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Adverse Event Reporting for Clinical Trials 9.23.05


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  • I am glad to be here with you here in Orlando
    What brought me here was my first meeting with socra this past February.
    I attended a SOP work shop which was very well done.
    On the plane ride home I sat next to The director Erich Lukas. I was telling him of my concerns with collection of adverse events, So, here I am 8 months later telling you the same.
    Today I am mainly going to focus on H&N trials which I work on and the collection of Adverse Events.
    I added to my slide presentation with updates post a meeting with my team.
    I think the additions were necessary, but you have the majority
  • When sitting behind the computer this is the frustration I sometimes feel about Adverse Event collection.
    I am sure many of you are also feeling the frustration with clinical trials and the demands you face with reporting and data gathering.
    But all or efforts are worth the cause, to provide our patients with the best possible treatment for their condition.
  • Some of you probably already know the history of RTOG, but for those of you who don’t
    RTOG (Radiation Therapy Oncology Group) is one of the 12 Cooperative Groups under the NCI it’s headquarters is in Philadelphia along with the ACRIN (American College of Imaging Network).
    The american college of radiology is a professional organization which promotes education and research for radiation.
    The Cooperative groups formed in 1958 after congresses approved funding for cancer trials,
    Cooperative groups include researchers, cancer centers, and community physicians throughout the United States, Canada, and Europe.
    The Radiation Therapy Oncology Group (RTOG) was initially organized in 1968 under the direction of Dr. Simon Kramer for the purpose of conducting radiation therapy research and cooperative clinical investigations.
    Funding from the National Cancer Institute began in 1971. The primary areas of research include: BRAIN, H&N, LUNG, GATROINTESTINAL, GENITOURINARY, SARCOMA AND GYNECOLOGICAL.
    Our primary mission is how best to use radiation for treatment of cancer, by itself with chemo and or surgery.
  • I have managed trials for head and neck studies for the past 5 years and have seen the advancement of medicine.
    Cancer trials are using combined modalities and new biologics to treat patients.
    The outcome is higher acute and late adverse events.
    Recent research of Head and Neck Studies have shown evidence that more aggressive regimens improve local tumor control and survival of patients with head and neck cancer.
    Better treatment outcomes, however have come at the expense of increased patient morbidity, increase in sever grade 3-4 mucositis that causes substantial pain, interferes with the patients ability to chew and swallow and worsens the patients quality of life.
  • Dr. Trotti a Radiation Oncologist and active member of RTOG; Raises the question in the Journal of Clinical Oncology.
    How do we know that the benefits outweigh the harms of these aggressive programs?
    He states: “The higher rates of adverse effects have been generally perceived as “worth it” by the oncology community”
    When decisions about new intervention are being made, the “net clinical benefit” of the intervention needs to be assessed.
    Adverse Events experienced in a trial must be known in sufficient detail for their severity and relationship to treatment allocation to be judged.
    Dr. Trotti and I spoke in length about this subject at our June meeting
    Its important to know that all of you who are in data collection play a critical role for the outcome of study analysis and for new standards of care in treatment.
  • Difference is survival rate, what is the cost….
  • Our Challenge at RTOG is to address this issue of poor AE reporting and incorporate better data collection methods to ensure
    better and accurate reporting.
    Dr. Trotti is championing in helping and encouraging us to improve or process so each study can be improved.
    He has been actively involved in recent developing studies which I will speak on later.
    And to give you more background on the driving force for change is from a working group called (AERO-H&N)
    Adverse evens reporting in oncology working group head and neck.
  • The Cooperative Groups use the NCI/CTCAE or Common Terminology Criteria, for the Collection of Adverse events.
    This is used to facilitate the recognition and severity of adverse effects.
  • This slide just show the history of the grading systems used for Oncology Trials
    Let me take you through it.
    The WHO was the first criteria used in 1979, it collected acute toxicities for patients treated with chemo
    1984 There is 3 criteria used:
    The Common Toxicity Criteria or CTC for acute toxicities the modality being chemo
    The other two criteria RTOG early and late was used grading radiation effects
    Soma 1995 for Rt late effects
    In 1998, CTC 2.0 for all modalities, but collected the acute phase only which is days 1-90
    The RTOG was used to capture late effects.
    Finally we have the CTCAE 3.0 which has 1058 terms for all organs,
    all modalities Chemo, RT, Surgery, Biologics for acute and late effects.
  • At Headquarters I frequently receive calls from RA’s in the field asking my help in deciphering how to grade adverse
    Most of the time I get these calls because their source documentation has minimal information to determine
    the grade of the event or it is very vague.
    This is why from the beginning of data collection it is important to use the common language.
    The use of too general or vague such as “feels bad” gastrointestinal symptoms will not translate for grading.
  • These are the general guidelines in when using CTC for grading Adverse Events
    Read definitions:
    Mild- A symptomatic, no intervention needed
    Mod- symptomatic intervention needed, some interference with function
    Sever- Very undesirable, multiple disruptive symptoms, more serious interventions are indicated
    Life Threatening- Disabling resulting in loss of organ, organ function or limb.
    Some events are inherently difficult to describe and grade. Using some personal judgment and being familiar with the general CTC severity scaling will help determine most suitable grade.
  • In Summary; the criteria is important as it provides
    Recognition of the injury
    Common language for communication
    FLYS IN; For future analysis
    Common Schema Severity Scaling; (the grading of 1-4 I just went over)
    Data for Toxicity verses Safety Profiles or (risk to benefit ratio)
    It drives interventions
  • In summing up using the criteria, I want to say that we are all human and a lot of the time we go with our personal impressions,feelings and opinions rather than relying on facts.
    Being objective as possible is the key, subjectivity ones own interpretation leads to inaccurate reporting.
  • Every system has its flaws and a few problems were identified with the grading system.
    CTC provides a common language to identify and report AE’s, but it does not have guidelines
    For data collection and patient screening.
    This causes a wide variations of how sites collect AE’s and the method of patient assessments.
    SOME Examples: Pt screening is the most important part; it should be specific, comprehensive assessment
    We receive hematologic toxicities, these are identifiable, but what the pt is experiencing is not getting reported
    Common side effects such as fatigue, alopecia, dry mouth are all considered part of the tx regimen
    By health personnel and dont’ get reported as an adverse event.
    The NCI is trying to rectify the problem of data collection, they are in the process of developing a software
    program called the “SAFE-T Manager. This will guide the user in AE data collection and transmission process.
    Further details are pending.
  • This slide contains information which has not been published. It is the basis for a poster that Dr. Clement Gwede is presenting at ASTRO this October. The manuscript will be submitted this November by Dr. Trotti
    53 Reports from Jan 1990 to July 2001 were reviewed;
    The reports were from Randomized phase III clinical trials for head and neck cancer patients
    Patients who were followed for 2-3 years -- 7/15 reported on late events which is 47%
    For Late organ function:
    Minimal reporting was seen for feeding tube and tracheostomy dependence ( H&N studies such as 9914 I mentioned before is concerned how many people still have to use a feeding tube.
    Mortality or deaths caused by tx: 27/53 reports addressed whether pts died from treatment related events 51%
    Impact of surgery was addressed 5 out of 11 trials which contained surgery.
    “The findings suggest there is under-reporting of adverse events to varying degrees, especially late events”
    To paraphrase
    “Explainations for adverse event reporting deficiences include a history of “efficacy driven” development of cancer theraputics and lack of uniform methods and standards for reporting harms.
    These deficiencies are serious as they can prevent clinicians from being able to provide patients with
    balanced information about the scale and scope of risks associated with the different treatment strategies.
    Patient with follow-up of 2-3 years only 7/15 47% reported on late events.
    Late organ function minimal reporting for feeding tube and tracheostomy dependence
    Mortality: 27/53 51% of reports addressed whether pts died from treatment related events.
    Impact of surgery was addressed 5 out of 11 trials which contained surgery.
    These deficiencies are serious as they can prevent clinicians from being able to provide patients with
    balanced information about the scale and scope of risks associated with the different treatment strategies.
  • What RTOG Head and Neck group plans to do is incorporate methods for directed assessments rather than passive data collection.
    We looked into updating current protocols which have already been activated 0234 and 0421.
    0234 has already accrued 80/230 patients to the study, it was determined we are unable to revise the forms at this time.
    0421 Revisions will take place in January after the protocol has gone through the institutions IRB’s.
    Revision of the forms will be discussed at the January meeting among the Study Chairs and statisticians.
    I will be discussing what revisions for the CRF are desired in my future slides.
    0522 will be activated late October
    This study follows one of our large phase III studies 0129
    For this study the CRF’s were changed using directed hard coded elements and protocol specific instructions for assessments
    and a tool to be used for patient assessments. The tool used for screening patients is called a “closed system”
    In which responses are entered as circles around the correct answer.
    (HANDOUT) This tool will have most of the common AE experienced by H&N patients, thus making assessments more uniform
    Consistent with no guess of the grading.
  • RTOG case report forms have changed over the past few years from more directed to passive AE assessments.
    The case report form listed here is from 0129 a phase III head and neck trial.
    These CRF have a some hard coded elements, but fewer than
    Prior studies. The TF collects 5 hard coded and F1 10 terms.
  • The NEW CRF for RTOG 0234 and other new studies now use this blank form for AE collection.
    No hard coding elements.
    With the statistics of poor AE reporting the concern is will we receive the late events
    which are under reported.
    There is a proposal to look at the potential gaps in AE capture by 3 different approaches used over 3 different RTOG trials
    99-11, 0129 and 0234. This project was not pursued do to other priorities.
  • To give you an example of problematic data collection:
    I picked this study 0022, to show how passive data collection fails.
    What I observed in the study prompted me to come and share my concerns with all of you.
    It gave me a personal understanding of the need for better reporting of AEs
    The Study 0022 is an IMRT (Intense Modualated Radiation Therapy) Study for Oropharyngeal Cancer Patients.
    This includes tumors of the tonsil, base of tongue or palate
  • The objectives of this study is to assess:
    if there is adequate target coverage and salivary gland sparing with imrt techniques
    To determine the rate and pattern of loco regional tumor recurrence
    And determe the nature and prevalence of acute and late side effects.
  • One of the late effects most concerned with is Xerostomia or layman’s terms dry mouth syndrom.
    The study was interested in reducing high radiation doses to the major salivary glands
    Parotid, submandibular and sublingual.
    These glands produce 90% of salivary secretions and the minor produce the remaining.
    Standard radiation for oral pharyngeal tumors involves high doses of radiation to salivary glands bilaterally.
    Causing significant decrease in salivary output and dry mouth syndrome.
    Xerostomia is one of the major late side effects of radiation
    And is one of the major causes of decreased quality of life.
    Dry mouth syndrome causes alterations in speech, taste and mastication difficulties in turn causing secondary nutritional
    Oral mucosal dryness creates a predisposition to fissures and ulcers. The changes in oral flora lead to dental caries and infections.
  • It was noted later, about 2 years after the study opened one CRF did not include xerostomia/dry mouth among the hard coded elements.
  • As a result the form was revised to include dry mouth. It is now listed as a hard coded element on the bottom left.
    2 of 17 institutions reported dry mouth prior to the form being revised.
    The remaining 15 institutions were queried and asked to grade dry mouth syndrome.
    Of the 15 cases queried 11 reported dry mouth.
    This showed me at the time and I hope it shows you how directed patient assessments
    Are more effective for adverse event collection.
    The FS Form was revised on 7/22/04 to include hard coded element “Dry Mouth.” It was not initially included
  • Sufficient information is needed on acute and late adverse effects to properly compare treatments and describe risks to patients.
    The two head and neck studies conducted currently are trying to answer the question as to which treatment
    Method is better for sparing the major salivary glands.
    0244 is a salivary gland transfer study. The patient comes on study with unilateral neck disease, the salivary glands are
    Transfer to the unaffected side and the radiation will be directed to the affected side only.
  • Study 0421 For this study I am going to focus on collection of base line and long term follow-up.
    This is a new phase III Re-Irradiation trial which opened in April of 05.
    Patients coming on study are patients; who were previously irradiated; with recurrent disease or new primary tumors.
    Currently the standard of care for these patients is chemotherapy alone.
    OBJECTIVE of this STUDY:
    The objective of this study is to determine if irradiation plus concurrent chemotherapy improves overall survival
    as compared to conventional chemotherapy alone.
    To compare progression free survival and assess toxicity of each treatment regimen.
  • Patients coming on this study will have been previously treated with at least 45 to a maximum of 75 gray.
    This means these patient will be coming onto this trial with multiple baseline adverse events from prior treatment.
    These base line symptoms should be captured prior to starting a new treatment regimen.
    Long term follow-up and close monitoring of post late radiation effects is key for outcomes in this trial.
    Capturing the late effects and severity of re-irradiation is pivitol in deciding if the oncology community will accept this
    Method for treating recurrent head and neck patients.
  • I want to give you a better understanding of base line assessments.
    Collection of baseline symptoms represent the background against which new or worsening symptoms are compared.
    When analyzing the benefit to risk ratio, it is necessary to eliminate those adverse reactions that were related to non-trial factors.
    The caveat, however is that some Aes worsen during treatment, these would be considered related to protocol treatment.
  • This is a CRF which is collected when the pt comes on study.
    We designed the with questions regarding the pts swallowing function.
    There is some talk to add additional base line questions and hard coded elements for follow-up
    This will be determined at our next RTOG meeting in January. Your welcome to join us at the Miami beach fountain blue resort…!
  • Study 0234 is a good example regarding problematic issues with grading adverse events which arise from
    Trials treating patients with new investigational drugs.
    This study is a phase II Randomized trial of patient who have had a gross total resection
    Followed by concurrent treatment with the new investigational drug C-225 /Cetuximab with chemotherapy
    Cisplatin or Docetaxel
    This studies main focus has been on the Cetuximab related rash:
    The rash associated with EGFR inhibitors is a new dermatologic condition.
    It appears to be acne form but it is not considered a form of acne; rather it is a form of folliculitis.
    Skin manifestations include: erythema, follicle based papules which may ulcerate; pain itching; cosmetic disturbance
    And nail disorders.
    This rash may become infected and transform into cellulites.
  • To grade this rash studies have been using the NCI/CTC criteria
    Because this is a new drug on the market, the CTC doesn’t have the most appropriate definitions that fit for categorizing and recording of the skin rash.
    Capturing the severity is important here because data from several trials have shown a positive correlation between rash and response and or survival
  • Dr. Trotti has been working with BMS and RTOG to enable clinicians to categorize and grade these effects.
    The above criteria is the latest for grading, this will be listed in our newest trial 0522, 0234 will be amended shortly with this grading scale.
    This probably will be update in as more information is obtained.
    For more information on the the erbitux rash I would recommend
  • Transcript

    • 1. The Challenges of Safety Data Collection Linda Messett RN BSN MA CCRP Research Associate, Data Management American College of Radiology Radiation Therapy Oncology Group
    • 2. How NOT to Ensure Accuracy in AE Reporting Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 3. ACRIN NSABP EORTC GOG ECOG NCIC NCIC COG RTOG SWOG NCCTG CALGB NCI Radiation Therapy Oncology Group ACOSOG National Cancer Institute Cooperative Groups SOCRA 9/2005 L. Messett
    • 4. New Therapies, New Dilemmas • Combined Therapeutic Modalities Are Proving Beneficial in Many Studies • Concerns Are Growing Regarding the High Rate Adverse Events Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 5. The Delicate Balance Toxicity Efficacy Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 6. Treatment Toxicity Timelines Start of Treatment End of Treatment Acute Toxicity Radiation Therapy Oncology Group 180 days Late Toxicity SOCRA 9/2005 L. Messett
    • 7. Comparison of Survival and Toxicity • 9003 Standard of Care (Radiotherapy 2 Gray/FX QD 5 Days/week 70 Gray) – Acute Grade 3+ 39% – Late Grade 3+ 27% – 4-Year Survival 33% • 9914 72 Gray/42 FXs/6 Weeks AFX-CB Plus Cisplatin 100mg/M2 days 1 &22 – Acute Grade 3+ 92% – Late Grade 3+ 42% – 4-year Survival 54% – Feeding Tube Prior to Registration 24% – Follow-up 83% One Year From Start of TX 41%, 4 Years From Start of TX 17% Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 8. Our Challenge • Solve the Dilemma of Poor AE Reporting • Devise Methods to Improve Accuracy and More Complete Capture of AEs • Continuously Improve Data Collection to Meet New Therapies Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 9. Oncology Uses The Common Terminology Criteria for Evaluating The Negative Effects of Cancer Treatment Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 10. Evolution of Adverse Events Grading Systems System # Terms # Organs WHO (1979) 28 CTC (1984) 48 RTOG-A (1984) 14 RTOG-L (1984) 16 SOMA (1995) 152 CTC v 2.0 (1998) 260 9 13 13 13 22 24 CTCAE v 3.0 (2003) 1058* Al Modality Chemo Chemo Acute RT Late RT Late RT Chemo/Acute RT All Acute & Late The First Comprehensive Grading System for All Modalities
    • 11. Use Common Language I can’t help you unless you are more specific. Do you feel “icky” or just “yucky?” Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 12. CTC Grading General guidelines Low Grade High grade 1 2 Mild Moderate A Symptomatic No Interventions Indicated Symptomatic: Interventions Such As Local Treatment or Meds May Be Indicated; Some Interference With Function, but No Impact on ADLs Radiation Therapy Oncology Group 3 Severe Very Undesirable; Multiple, Disruptive Symptoms; More Serious Interventions, Including Surgery or Hospitalization May Be Indicated. SOCRA 9/2005 4 Life Threatening Life Threatening Catastrophic, Disabling or Result in Loss of Organ, Organ Function, or Limb. L. Messett
    • 13. Adverse Event Terminology & Grading Important Because It Provides: • Recognition of the Injury • Common Language for Communication • Common Schema for Severity Grading • Data for Toxicity/Safety Profiles • Drives Interventions Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 14. Interpret Subjective Symptoms in an Objective Manner Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 15. At Issue With the Grading System Currently No Reporting Guidelines For: • Data Collection • Patient Screening Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 16. The Negative Result 53 Papers From 41 Trials Show Wide Variations in Grading Systems and Reporting Methods: • Only 47% Reported on Late Events • Late Organ Function: – Only 3% Addressed Feeding Tube Dependence; – Only 7% Discussed Tracheostomy Dependence • Only 51% Reports Addressed Treatment Related Mortality Systematic Review of Variations in Safety Reporting In Phase III H&N Trials (1990-2003) Trotti A., Gwede C. (Submitted: ASTRO 3/2005) Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 17. Identified Improvements for RTOG Head & Neck Studies • Form Redesign for The Following Studies: – – • 0421 (Revision pending January) 0234 (The forms will not be updated) Improve Directed Patient Assessments for Capturing AEs (RTOG 0522) Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 18. RTOG 0129 Form RT Summary (Acute) Follow-up (Late) Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 19. New AE Case Report Form Protocol-Specific AE Form Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 20. RTOG 0022 Phase I/II Study: Conformal & Intensity Mod. Radiation for Oropharyngeal Cancer Eligibility: Squamous Cell Ca of the Oralpharyngeal (Tonsil, Base of Tongue or Palate) • T1-T2, No-n1, Mo • No Prior Surgery to the Tumor or Nodal Disease • No Radiotherapy to the Head and Neck; • No Previous Chemotherapy, Etc. Treatment Plan: • Conformal and or IMRT Techniques Utilized to Deliver a Maximum of 66 GY/30 Fractions. • The Major Salivary Gland Will Be Spared According to Specific Criteria. • Salivary Output Will Be Measured Before and Following Therapy. Oncology Group SOCRA 9/2005 L. Messett Radiation Therapy
    • 21. 0022 Protocol Objectives • Assess the Feasibility of Adequate Target Coverage and Major Salivary Gland Sparing in Patients With Oropharygeal Cancer Treated With IMRT Techniques. • Determine the Rate and Pattern of Locoregional Tumor Recurrence. • Determine the Nature and Prevalence of Acute and Late Side Effects (Using RTOG Scales) and Their Relationship to Local Dose. Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 22. Dry Mouth Syndrome (Xerostomia) • Determines Nature and Prevalence of Acute and Late Side Effects (Using RTOG Scales) • Determines Relationship to Local Dose Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 23. RTOG Head & Neck Form 0022 • Form Design Weakness Identified: Dry Mouth/Xerostomia AE Not Captured on the Majority of CRFs Sent to RTOG • Corrected Form Improves Data Collection Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 24. Revised FS Form for Study 0022 Form Now Includes Hard Coded Element: “Dry Mouth”
    • 25. Accurate Analysis of Adverse Effects Needed Which Treatment(s) Might Provide the Best Outcome to Preserving Salivary Gland Function? • 0022 IMRT • 0244 Salivary Gland Transfer • Radio-protectors: Pilocarpine/Amifostine Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 26. RTOG 0421 Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-irradiation and Chemo. vs. Chemo. Only Eligibility • Recurrent or Second Primary SCC of the Oral Cavity, Oropharynx, Hypopharynx, Larynx or Recurrent Neck Metastases With Unknown Primary • Measurable Disease • Patients Must Be Surgically Inoperable • No Signs of Carotid Exposure • Must Have Had Prior Radiation to the Head and Neck 45 to 75 Gray Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 27. 0421 Study Shows Why Baseline Data Is Important Patients in 0421 Study Have Had at Least 45 and up to a Maximum of 75 Gray Adverse Event Collection at Baseline & Careful Long Term Screening is Key for this Study Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 28. Differentiating Between a Baseline Symptom and A New One Can Be Challenging. Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 29. Collect Baseline Dysphagia Example: Study Form 0421 I1 CRF Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 30. RTOG Head & Neck Study 0234 Mild Moderate • Chemotherapy • Radiotherapy • C-225 (Cetuximab) • Recognition and Grading of Erbitux Rash Severe Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 31. Criteria Problems RTOG Head & Neck Study 0234 • Proper Grading Needed to Capture Skin Rash • Some Reports Suggest the More Severe the Rash, Perhaps the Better Outcome and Survival Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 32. CTC Terms Relevant for Grading EGFRi Rash Mild Mod Severe Disabling Pruritus/itching* 1 Mild of Localized 2 Intense or Widespread 3 Intense or Widespread And Interfering With ADL Macular or Papular Severe, Generalized EruptioN or Erythema With Erythroderma or Pruritus or Other Macular, Papular or Associated Symptoms; Vesicular Eruption; Localized Desquamation or Desquamation Covering Other Lesions Covering < > 50% Bsa 50% of Body Surface Area (Bsa) Rash/desquamation* Macular or Papular Eruption or Erythema Without Associated Symptoms Rash/acne/acneiform * Intervention Not Indicated Intervention Indicated Nail Changes* Discoloration; Ridging (Koilonychias); Pitting 4 - Partial or Complete Loss of Interfering With ADL Nail(s); Pain in Nail Bed(s) Rash: Dermatitis Associated With Radiation: − Select: − Chemo Radiation − Radiation 1 Faint Erythema or Dry Desquamation Radiation Therapy Oncology Group 2 Moderate to Brisk Desquamation Erythema; Patchy Moist, Mostly Confined to S kin Folds And Creases; Moderate Edema Generalized, Exfoliative, Ulcerative, or Bullous Dermatitis Associated With Pain, Disfigurement, Ulceration, or Desquamation 3 Moist Desquamation Other Than Skin Folds And Creases; Bleeding Induced by Minor Trauma or Abrasion SOCRA 9/2005 - - 4 Skin Necrosis or Ulceration of Full Thickness Dermis; Spontaneous Bleeding From Involved Site L. Messett
    • 33. Early And Late Effects Are Pivotal in Deciding New Standards of Care • Randomized Trials Needed to Estimate the Benefits of Combined or Single Therapies • Accurate Data Can Answer Whether Added Toxicity Provides Additional Benefits • Definitive Data Needed Before Therapies Become an Accepted Community Standard for a Patient Population Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 34. RTOG Plan of Action  Provide Clear Definitions for Grading AEs Not Clearly Defined in CTCAE 3.0  Provide a Check List to Use for Patient Assessments  Use More Hard Coded Elements on CRFs  Provide Protocol Specific Instruction for Assessments  Add Question to the Case Report Forms to Capture Base Line Information. E.G. 0421 Forms Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 35. What You Can Do ... • Review the Protocol Become Familiar With the Expected AEs for All Modalities Used • Create a Checklist for Consistent Patient Assessment • If Documentation is Lacking Ask the Person Assessing the Patient for More Information or an Addendum. • Follow Your Patient After Treatment Is Over to Capture the Late Effects Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett
    • 36. Thank You! Radiation Therapy Oncology Group SOCRA 9/2005 L. Messett