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

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Cameron Bond
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1 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 TREATMENT 1 ASSIGNED TREATMENT ARM(1) 1 Arm 1 2 Arm 2 2 PATIENT HEIGHT (CM)(2) A REASON FOR DOSE MODIFICATION modification 2 Disease progression, relapse during active treatment 3 Adverse event/side effects/complications 4 Death on study 5 Patient withdrawal / refusal after beginning protocol therapy 6 Patient withdrawal / refusal prior to beginning protocol therapy 7 Alternative therapy 8 Other complicating disease 98 Other B REASON TREATMENT TERMINATED 1 Treatment completed per protocol criteria 2 Disease progression, relapse during active treatment 3 Adverse event / side effects / complications 4 Death on study 5 Patient withdrawal / refusal after beginning protocol therapy 6 Patient withdrawal / refusal prior to beginning protocol therapy 7 Alternative therapy, specify in comments 8 Patient off (protocol) treatment for other complicating disease (followup and data submission will continue) 98 Other, specify in comments 3 ARM 1 ONLY - DAY 1 PATIENT WEIGHT (KG, )(26) BODY SURFACE AREA (M 2, )(27) BODY SURFACE AREA (M 2,VALUE USED TO CALCULATE DOSE IF BSA> 2)(28) Agent Name CISPLATIN Date Agent Administered - - (29) Agent Total Dose (mg) (30) (use code table A) (31) (use code table B) (32) 1016 a of 10

2 3a DAY 22 PATIENT WEIGHT (KG, )(33) BODY SURFACE AREA (M 2, )(34) BODY SURFACE AREA (M 2,VALUE USED TO CALCULATE DOSE IF BSA> 2) (35) Agent Name CISPLATIN Date Agent Administered - - (36) Agent Total Dose (mg) (37) (use code table A) (38) (use code table B) (39) 3b DID PATIENT RECEIVE ANY NON- PROTOCOL CETUXIMAB DURING RADIATION THERAPY?(40) 4 ARM 2 ONLY - WEEK 1 - INITIAL DOSE PATIENT WEIGHT (KG)(41) BODY SURFACE AREA(M 2 )(42) Date Agent Administered - - (43) Agent Total Dose (mg) (44) (use code table A) (45) (use code table B) (46) 4a WEEK 2 PATIENT WEIGHT (KG)(47) BODY SURFACE AREA(M 2 )(48) Date Agent Administered - - (49) Agent Total Dose (mg) (50) (use code table A) (51) (use code table B) (52) 1016 a of 10

3 4b WEEK 3 PATIENT WEIGHT (KG)(53) BODY SURFACE AREA(M 2 )(54) Date Agent Administered - - (55) Agent Total Dose (mg) (56) (use code table A) (57) (use code table B) (58) 4c WEEK 4 PATIENT WEIGHT (KG)(59) BODY SURFACE AREA(M 2 )(60) Date Agent Administered - - (61) Agent Total Dose (mg) (62) (use code table A) (63) (use code table B) (64) 4d WEEK 5 PATIENT WEIGHT (KG)(65) BODY SURFACE AREA(M 2 )(66) Date Agent Administered - - (67) Agent Total Dose (mg) (68) (use code table A) (69) (use code table B) (70) 4e WEEK 6 PATIENT WEIGHT (KG)(71) BODY SURFACE AREA(M 2 )(72) Date Agent Administered - - (73) Agent Total Dose (mg) (74) (use code table A) (75) (use code table B) (76) 1016 a of 10

4 4f WEEK 7 PATIENT WEIGHT (KG)(77) BODY SURFACE AREA(M 2 )(78) Date Agent Administered - - (79) Agent Total Dose (mg) (80) (use code table A) (81) (use code table B) (82) 4g WEEK 8 PATIENT WEIGHT (KG)(83) BODY SURFACE AREA(M 2 )(84) Date Agent Administered - - (85) Agent Total Dose (mg) (86) (use code table A) (87) (use code table B) (88) 4h DID PATIENT RECEIVE ANY NON-PROTOCOL CISPLATIN DURING RADIATION THERAPY?(89) 5 DID THE PATIENT RECEIVE ANY ADDITIONAL SUPPORTIVE CARE DURING THE REPORTING PERIOD? (SEE PROTOCOL 90) (91) 5a IF YES, TYPE OF SUPPORTIVE CARE GIVEN; SPECIFY (92) 6 WAS THE PATIENT HOSPITALIZED FOR ANY TREATMENT RELATED COMPLICATIONS IN THIS REPORT PERIOD?(93) 1016 a of 10

5 7 DOES THE PATIENT CURRENTLY REQUIRE TUBE FEEDING?(94) 7a IF YES, IS PATIENT DEPENDENT ON TUBE FEEDING FOR >50% OF NUTRITIONAL SUPPORT?(95) 8a DENTAL GINGIVAL HEALTH (96) 0 Normal: Edentulous, with no gingival disease; native teeth in place with gingiva in excellent condition 1 Mild changes/good dental health: mild periodontal inflammation-routine cleaning indi cated; < 5 restorations indicated; no extractions indicated 2 Moderate/fair dental health: moderate periodontal inflammation; deep perodontal cleaning indicated; 6 or more restorations indicated; less than full mouth extractions indicated 3 Severe changes in dental health: widespread periodontal disease with extensive procedure/ surgery indicated; full month extractions indicated 4 Life-threatening dental condition: extensive abscess, extensive soft tissue or bone infection, sepsis; urgent intervention indicated 8b NUMBER OF NATIVE TEETH IN PLACE (0-32)(97) 1016 a of 10

6 9 PROTOCOL SPECIFIC ADVERSE EVENT EVALUATION Code each of the following using Version 4 (MedDRA 12) 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 CODE 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 C AE led to discontinuation of treatment TERM GRADE BEGIN DATE A B C Ear and labyrinth disorders Hearing impaired (115) - - (116) (117) (118) (119) Tinnitus (120) - - (121) (122) (123) (124) Gastrointestinal disorders Constipation (125) - - (126) (127) (128) (129) Diarrhea (130) - - (131) (132) (133) (134) Dry mouth (135) - - (136) (137) (138) (139) Dyspepsia (140) - - (141) (142) (143) (144) Dysphagia (145) - - (146) (147) (148) (149) Mucositis oral (150) - - (151) (152) (153) (154) Nausea (155) - - (156) (157) (158) (159) Vomiting (160) - - (161) (162) (163) (164) General disorders & administraton site conditions Fatigue (165) - - (166) (167) (168) (169) Pain (170) - - (171) (172) (173) (174) Injury, poisoning and procedural complications Dermatitis radiation (175) - - (176) (177) (178) (179) Metabolism & nutrition disorders Anorexia (180) - - (181) (182) (183) (184) Musculoskeletal and connective tissue disorders Avascular necrosis (185) - - (186) (187) (188) (189) Head soft tissue necrosis (190) - - (191) (192) (193) (194) Neck soft tissue necrosis (195) - - (196) (197) (198) (199) Trismus (200) - - (201) (202) (203) (204) 1016 a of 10

7 9 PROTOCOL SPECIFIC ADVERSE EVENT EVALUATION Code each of the following using Version 4 (MedDRA 12) 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 CODE 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 C AE led to discontinuation of treatment TERM GRADE BEGIN DATE Nervous system disorders A B C Dysgeusia (205) - - (206) (207) (208) (209) Peripheral sensory neuropathy (210) - - (211) (212) (213) (214) Psychiatric disorders Insomnia (215) - - (216) (217) (218) (219) Respiratory, thoracic and mediastinal disorders Cough (220) - - (221) (222) (223) (224) Pharyngeal mucositis (225) - - (226) (227) (228) (229) Skin and subcutaneous tissue disorders Alopecia (230) - - (231) (232) (233) (234) Dry skin (235) - - (236) (237) (238) (239) Nail loss (240) - - (241) (242) (243) (244) Pruritus (245) - - (246) (247) (248) (249) Rash acneiform (250) - - (251) (252) (253) (254) Rash maculo-papular (255) - - (256) (257) (258) (259) 1016 a of 10

8 10 NEW OR CONTINUING ADVERSE EVENTS? (not reported Q9) (300) (skip to comments) Adverse Events: Use the CTCAE version 4 (MedDRA 12) 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 CODE 1 Unrelated 2 Unlikely 3 Possible 4 Probable 5 Definite B SAE Report Submitted C AE led to discontinuation of treatment MedDRA Code CTCAE Term (specify if "other") CTCAE Grade CTCAE Begin Date A B C (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) (396) (397) (398) (399) (400) (401) - - (402) (403) (404) (405) (406) (407) (408) - - (409) (410) (411) (412) (413) (414) (415) - - (416) (417) (418) (419) (420) (421) (422) - - (423) (424) (425) (426) (427) (428) (429) - - (430) (431) (432) (433) 1016 a of 10

9 11 INDICATE UNITS TO BE USED FOR LAB VALUES(698) 1 Conventional 2 SI 12 LAB VALUES USING STANDARD US UNITS INSTRUCTIONS: Record laboratory values USING STANDARD US UNITS include normal ranges Normal Range Pre-Rx Date (mm/dd) Year: / / / / / / / / Hgb (g/dl) Hct (%) WBC (x1000) mm 3 Platelets (x1000) mm 3 Neutrophils (%) ANC (mm 3 ) Sodium (meq/l) Potassium (meq/l) Chloride (meq/l) BUN (mg/dl) Creatinine (mg/dl) Calc Creatinine Clear (ml/min) Total Bilirubin (mg/dl) Alk PO4 (ImU/ml) LDH (U/L) SGOT (IU/L) SGPT (IU/L) Total Protein (g/dl) Albumin (g/dl) Uric Acid (mg/dl) Calcium (mg/dl) Glucose(mg/dl) Mg (meq/l) U/A COMMENTS ( ) The reported case report information has been reviewed and confirmed by the principal investigator (1275) Person completing form - - (1276) Date 1016 a of 10

10 13 LAB VALUES USING STANDARD INTERNATIONAL UNITS INSTRUCTIONS: Record laboratory values USING STANDARD INTERNATIONAL UNITS include normal ranges Normal Range Pre-Rx Date (mm/dd) Year: / / / / / / / / Hgb (mmol/l) Hct (volume fraction) WBC (x10 9 liter) Platelets (x10 9 liter) Neutrophils (fraction) ANC (mm 3 ) Sodium (mmol/l) Potassium (mmol/l) Chloride (mmol/l) BUN (mmol/l) Creatinine (umol/l) Calc Creatinine Clear (ml/sec/m 2 ) Total Bilirubin (umol/l) Alk PO4 (U/L) LDH (IU/L) SGOT (U/L) SGPT (U/L) Total Protein (g/l) Albumin (g/l) Uric Acid (mmol/l) Calcium (mmol/l) Glucose (mmol/l) Mg (mmol/l) U/A COMMENTS ( ) The reported case report information has been reviewed and confirmed by the principal investigator (1840) Person completing form - - (1841) Date 1016 a of 10

B. PANITUMUMAB DOSE LEVEL 0 No dose reduction 1 Level -1 2 Level Other, specify in comments for this cycle

B. PANITUMUMAB DOSE LEVEL 0 No dose reduction 1 Level -1 2 Level Other, specify in comments for this cycle Radiation Therapy Oncology Group Phase II Study Pre-operative Chemo- Radiation + Panitumumab for Potentially Operable Lung Cancer Concurrent Summary Form AMENDED DATA YES INSTRUCTIONS: Submit all pages