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2	The Case Study--- Your site has chosen a protocol (Sample trial 7776) for site activation and eventual patient accrual. In order to get this ball rolling, you need to ---
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9	RTOG 7776 An “Abridged” Trial 1. Not all sections of a standard trial have been included in your handout 2. We have included enough info to complete the case study- and hopefully not enough information to lose you!
10	RTOG 7776 An “Abridged” Trial 3. The protocol in this handout should never be used to treat patients 4. Similarities to any active RTOG trials are purely coincidental!!!
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23	Forms Review A5- Demographic form I1- Initial Evaluation form TF- Treatment Summary with AE - Adverse Event form F1- Follow-up form with AE - Adverse Event form
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46	BREAK OUT GROUPS
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52	"TF forms collect" TF forms collect drug information. Surgery and Radiation are collected on unique forms for those modalities.
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57	Treatment Plan Cetuximab (also known as C225) -Week 1- Loading dose at 400 mg/m2 -Weeks 2 to 7 at 250 mg/m2 Cisplatin (since arm 1) -Weeks 2 to 7 at 30 mg/m2 Radiation therapy -Weeks 2 to 7 for minimum dose of 58 Gy to max dose 66 Gy
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59	Tf page 1 typed
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89	Review the source documentation regarding the patient’s three-month follow-up visit and complete the F1 form. Also complete an AE case report form for any adverse events, if applicable. Discussion questions are listed at the end. A selected list of MEdDRA codes are found on the last page of this hand-out.
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93	"When was the tongue mass..." When was the tongue mass first identified? What was the last contact date? Where is the biopsy reported on the form? Is this a recurrence of the primary or a new primary tumor? If the patient has another type of cancer, is the treatment for that cancer reported in Question 10? If the patient had nodal disease in the left neck at his 3 month follow-up, would you consider this to be nodal recurrence or new regional disease?
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