PLACE LABEL HERE. Radiation Therapy Oncology Group Phase II Nasopharyngeal Cancer Follow-Up Form

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Tamsin Baldwin
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1 F1 AMENDED DATA Radiation Therapy Oncology Group Phase II Nasopharyngeal Cancer Follow-Up Form YES No INSTRUCTIONS: Submit this form at the appropriate follow-up interval and at death Dates are recorded as mm-dd-yyyy unless otherwise specified 1 TIMEPOINT(1) 11 Year 1, month 2 (after completion of concurrent treatment) 12 Year 1, month 4 (after completion of adjuvant treatment) 13 Year 1, month 6 14 Year 1, month 9 15 Year 1, month Year 2, month 3 17 Year 2, month 6 18 Year 2, month 9 19 Year 2, month Year 3, month 6 21 Year 3, month Year 4, month 6 23 Year 4, month Year 5, month 6 25 Year 5, month Year 6, or later 2 DATE OF LAST CONTACT OR DEATH - - (2) 6 DOES THE PATIENT CURRENTLY REQUIRE TUBE FEEDING?(8) 6a IF YES, IS PATIENT DEPENDENT ON TUBE FEEDING FOR >50% OF NUTRITIONAL SUPPORT?(9) 7 WAS A FEEDING TUBE INSERTED DURING THIS REPORTING PERIOD?(10) 7a DATE FEEDING TUBE PLACED - - (11) 3 PATIENT'S VITAL STATUS(3) 1 Alive 2 Dead 4 PRIMARY CAUSE OF DEATH(4) 1 Due to this disease (local, regional, or distant) 2 Due to second primary or other malignancy 3 Due to protocol treatment (specify below) 4 Due to other cause (specify below) Specify (5) 5 DOES THE PATIENT CURRENTLY HAVE SWALLOWING PROBLEMS?(6) 5a IF YES, HOW LONG HAVE SWALLOWING PROBLEMS BEEN PRESENT?(7) 1 Less than 1 month 2 1 to <7 months 3 7 to <13 months 4 13 to <19 months 5 19 to <24 months 6 2 years or longer 8 WAS A FEEDING TUBE DISCONTINUED DURING THIS REPORTING PERIOD?(12) 8a IF YES, DATE FEEDING TUBE DISCONTINUED - - (13) 9 WAS A TRACHEOSTOMY PERFORMED DURING THIS REPORTING PERIOD?(14) 9a IF YES, DATE TRACH PLACED - - (15) 10 WAS USE OF A TRACHEOSTOMY DISCONTINUED DURING THIS REPORTING PERIOD?(16) 10a IF YES, DATE TRACHEOSTOMY WAS CLOSED - - (17) 0615 F1d of 8

2 11 HAS THE PATIENT HAD A DOCUMENTED CLINICAL ASSESSMENT FOR THIS CANCER (SINCE SUBMISSION OF THE PREVIOUS FOLLOW-UP FORM)?(18), date of last clinical assessment - - (19) 12 HAS THE PATIENT BEEN DIAGNOSED WITH FIRST LOCAL-REGIONAL RECURRENCE OR PROGRESSION (SINCE SUBMISSION OF THE PREVIOUS FOLLOW-UP FORM)?(20) 0 Not applicable, patient has not been assessed 12a DATE OF FIRST LOCAL-REGIONAL PROGRESSION - - (21) 13 HAS THE PATIENT BEEN DIAGNOSED WITH FIRST DISTANT RECURRENCE OR PROGRESSION (SINCE SUBMISSION OF THE PREVIOUS FOLLOW-UP FORM)?(22) 0 Not applicable, patient has not been assessed 13a DATE OF FIRST DISTANT PROGRESSION - - (23) NEW PRIMARY SITE 00 None 01 Oral cavity 02 Oropharynx 03 Hypopharynx 04 Larynx 05 Nasopharynx 06 H + N 07 AML/MDS* 08 BCC 14a DATE OF DIAGNOSIS - - (28) 09 Bladder 10 Brain 11 Colorectal 12 Esophageal 13 Gastric 14 Liver 15 Lung 16 Melanoma 17 NHL No 14b SITE(S) OF NEW PRIMARY (USE CODETABLE BELOW) (29) (30) (31) 18 Pancreatic 19 Renal 20 Squamous-Skin 21 Prostate 22 Hematologic,specify 23 solid, specify 24 Unknown primary *If new primary is AML/MDS, please submit report via AdEERS 15 WAS ANY NON-PROTOCOL THERAPY GIVEN (RELATED TO CANCER UNDER STUDY SINCE SUBMISSION OF THE PREVIOUS FOLLOW-UP FORM)? 15a NON-PROTOCOL SURGERY(32) Non-protocol surgery date - - (33) 13b SITE(S) OF DISTANT PROGRESSION (USE CODETABLE FROM Q14) (24) (25) (26) 14 HAS A NEW PRIMARY CANCER OR MDS (MYELODYSPLASTIC SYNDROME) BEEN DIAGNOSED (SINCE SUBMISSION OF THE PREVIOUS FOLLOW-UP FORM)?(27) 0 Not applicable, patient has not been assessed 15b 15c 15d 15e NON-PROTOCOL CHEMOTHERAPY(34) Non-protocol chemotherapy date - - (35) NON-PROTOCOL BIOLOGIC RESPONSE MODIFIER(36) Non-protocol biologic response modifier date - - (37) NON-PROTOCOL RADIATION THERAPY(38) Non-protocol RT start date - - (39) OTHER NON-PROTOCOL THERAPY(40) non-protocol therapy start date - - (41) 0615 F1d of 8

3 PROTOCOL TREATMENT 16 PATIENT HEIGHT (CM)(52) No 17 PATIENT WEIGHT (KG)(53) 18 BODY SURFACE AREA (M 2 )(54) 19 TREATMENT PHASE(55) 1 Concurrent 2 Adjuvant Maintenance 4 Post-treatment follow-up (skip to Q31) 20 HAS PROTOCOL TREATMENT BEEN COMPLETED PER PROTOCOL OR TERMINATED PRIOR TO COMPLETION?(56) (treatment is continuing) AGENT NAME Bevacizumab Cisplatin 5-FU 21 AGENT START DATE (FOR CYCLES BEING REPORTED) (57) - - (66) - - (75) AGENT END DATE (FOR CYCLES BEING REPORTED) (58) - - (67) - - (76) AGENT DOSE #1 (59) (68) (77) 24 AGENT DOSE #2 (60) (69) (78) 25 AGENT DOSE #3 (61) (70) (79) 26 AGENT DOSE #4 (62) (71) (80) 27 TOTAL NUMBER OF CYCLES GIVEN (FOR CYCLES BEING REPORTED) (63) (72) (81) 28 REASON FOR DOSE MODIFICATION (Use code table below) (64) (73) (82) 29 REASON TREATMENT ENDED (Use code table below) (65) (74) (83) 0 None 1 Treatment completed per protocol criteria 2 Disease progression, relapse during active treatment 3 Toxicity/side effects/complications 4 Death on study 5 Patient withdrawal or refusal after beginning protocol therapy 6 Patient withdrawal or refusal prior to beginning protocol therapy 7 Alternative therapy, specify alternative therapy (84) 8 complicating disease, specify complicating disease (85) 98, specify (86) 0615 F1d of 8

4 No 30 INSTRUCTIONS: Record laboratory values and normal ranges See protocol for lab schedules Grade lab abnormalities on page 1 Date (mm-dd) Year: Pre-Rx / / / / / Treatment Week Hgb (gms) Hct (%) WBC (x1000) Platelets (x1000) Neutrophils/gran (%) ANC BUN Creatinine (mg%) Calc Creatinine Clearance Bilirubin (total) (mg%) Alkaline Phosphatase LDH SGOT SGPT Total Protein (gm%) Uric Acid (mg%) Albumin (gm%) Potassium (mg/l) Calcium (mg/d) Chemistries Blood Studies Glucose Sodium (meq/l) Normal Range Remarks (use R1, R2, R3, etc) Comments 0615 F1d of 8

5 No 31 Protocol Specific Adverse Event Evaluation Code each of the following using CTC AE Version 30 Score most severe grade observed during report period (Grade 1-5) If the AE did not occur, code "0" If unknown code "9" LEAVE NO GRADE BLANK AE's > grade 3 require date of onset Assign attribution to protocol treatment for each AE reported; indicate whether SAE was submitted Document unrelated AE's if > grade 3 and during or within 30 days of completing protocol treatment A Attribution to Protocol Treatment See protocol sections 6 & 7 for definitions of "protocol treatment" 1 Unrelated 2 Unlikely 3 Possible 4 Probable 5 Definite B Serious Adverse Event Report Submitted CTC AE TERM GRADE START DATE A B Neuropathy: sensory (97) - - (98) (99) (100) Pain - Neuralgia/peripheral nerve (101) - - (102) (103) (104) Hearing: patients without baseline audiogram and not in monitoring program (105) - - (106) (107) (108) Edema, larynx [Includes need for tracheostomy] (109) - - (110) (111) (112) Dysphagia (difficulty swallowing) (113) - - (114) (115) (116) Mucositis/stomatitis (clinical exam) -Oral Cavity (117) - - (118) (119) (120) -Pharynx (121) - - (122) (123) (124) -Larynx (125) - - (126) (127) (128) Dry mouth / salivary gland, (xerostomia) (129) - - (130) (131) (132) Induration/fibrosis (skin and subcutaneous tissue) (133) - - (134) (135) (136) Osteonecrosis (avascular necrosis) [includes maxilla and scull] (137) - - (138) (139) (140) Soft tissue necrosis -Head (141) - - (142) (143) (144) -Neck (145) - - (146) (147) (148) Rash:dermatitis associated with radiation -Radiation (149) - - (150) (151) (152) -Chemoradiation (153) - - (154) (155) (156) 0615 F1d of 8

6 32 WERE THERE ANY HEMORRAGE EVENTS DURING THIS REPORT PERIOD?(167) (skip to Q34) Protocol Specific Adverse Event Evaluation Code each of the following using CTC AE Version 30 Score most severe grade observed during report period (Grade 1-5) If the AE did not occur, code "0" If unknown code "9" LEAVE NO GRADE BLANK AE's > grade 3 require date of onset Assign attribution to protocol treatment for each AE reported; indicate whether SAE was submitted Document unrelated AE's if > grade 3 and during or within 30 days of completing protocol treatment No A Attribution to Protocol Treatment See protocol sections 6 & 7 for definitions of "protocol treatment" 1 Unrelated 2 Unlikely 3 Possible 4 Probable 5 Definite B Serious Adverse Event Report Submitted CTC AE TERM GRADE START DATE A B Hemorrhage, CNS (168) - - (169) (170) (171) (172) (173) (174) Hemorrhage, pulmonary/upper respiratory - Nose (175) - - (176) (177) (178) (179) (180) (181) Hemorrhage, pulmonary/upper respiratory - Pharynx (182) - - (183) (184) (185) (186) (187) (188) Hemorrhage, GI - Upper GI NOS (189) - - (190) (191) (192) (193) (194) (195) Hemorrhage, GI - Abdomen NOS (196) - - (197) (198) (199) (200) (201) (202) Hemorrhage, GI - Lower GI NOS (203) - - (204) (205) (206) (207) (208) (209) 0615 F1d of 8

7 Record below any hemorrhagic event experienced in this report period that was not specified in Q32 If none, skip to Q33 Adverse Event Code GRADE START DATE No A B (210) (211) - - (212) (213) (214) (215) (216) (217) (218) (219) - - (220) (221) (222) (223) (224) (225) (226) (227) - - (228) (229) (230) (231) (232) (233) 33 If any hemorrhagic event was experienced in this report period, record below the lab values at the time of hemorrhage If none, skip to Q34 INR (International Normalized Ratio of prothrombin time) Value (244) LLN (245) ULN (246) PTT (Partial Thromboplastin Time) Value (247) LLN (248) ULN (249) PT (Prothrombin Time) Value (250) LLN (251) ULN (252) Platelets (x1000 / cmm) Value (253) LLN (254) ULN (255) 34 DID THE PATIENT EXPERIENCE A GRADE 5 ADVERSE EVENT OTHER THAN THOSE SPECIFIED ABOVE?(266) (skip to Q35) Adverse Event Code GRADE START DATE A B (267) (268) - - (269) (270) (271) (272) (273) (274) 0615 F1d of 8

8 35 ANY CONTINUING OR NEW TREATMENT RELATED ADVERSE EVENTS SINCE LAST REPORT? (Not reported in Q31-34)(300) (skip to comments) No Adverse Events: Use the CTCAE version 30 to code all events Score most severe grade observed during report period (grade 1-5) Adverse Events of grade 3 or higher require start date Assign attribution to protocol treatment for each AE and indicate if an SAE was reported A Attribution to Protocol Treatment 1 Unrelated 2 Unlikely 3 Possible 4 Probable 5 Definite Adverse Event Code B SAE Report Submitted Adverse Event Shortname (specify if "other") Grade Start Date A B (301) (302) (303) - - (304) (305) (306) (307) (308) - - (309) (310) (311) (312) (313) - - (314) (315) (316) (317) (318) - - (319) (320) (321) (322) (323) - - (324) (325) (326) (327) (328) - - (329) (330) (331) (332) (333) - - (334) (335) (336) (337) (338) - - (339) (340) (341) (342) (343) - - (344) (345) (346) (347) (348) - - (349) (350) (351) (352) (353) - - (354) (355) (356) (357) (358) - - (359) (360) (361) (362) (363) - - (364) (365) (366) (367) (368) - - (369) (370) (371) (372) (373) - - (374) (375) (376) (377) (378) - - (379) (380) (381) (382) (383) - - (384) (385) (386) (387) (388) - - (389) (390) (391) (392) (393) - - (394) (395) COMMENTS (501) (502) - - (503) Person completing form Form completion date, original 0615 F1d of 8

INSTRUCTIONS: 1. Use codetable on page 1 for modifications / termination reasons

INSTRUCTIONS: 1. Use codetable on page 1 for modifications / termination reasons Radiation Therapy Oncology Group Phase III Head & Neck Cancer Treatment Summary Form AMENDED DATA YES INSTRUCTIONS: 1 Use codetable on page 1 for modifications / termination reasons SUMMARY OF SYSTEMIC