ASSIGNED TREATMENT ARM
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1 SF Radiation Therapy Oncology Group Phase III Lung High-dose vs Standard-dose Conformal XRT with Chemotherapy Consolidation Treatment Summary Form RTOG Study No Case # AMENDED DATA YES INSTRUCTIONS: Form is submitted 1 week after completion or termination of consolidation treatment. All 7 pages of the form must be submitted. Dates are mm-dd-yyyy unless specified otherwise. 1. HEIGHT (CM) (1) 2. WEIGHT (KG) (2) 3. BSA (M2) (3) 4 GENDER (4) 1 Male 2 Female 5 AGE (5) 6 ASSIGNED TREATMENT ARM (6) 1 (Chemo and standard dose 60 Gy paclitaxel and carboplatin on days 64 and 85.) 2 (Chemo and high dose 74 Gy - paclitaxel and carboplatin on days 71 and 92) 3 (Chemo and standard dose 60 Gy - paclitaxel and carboplatin on days 71 and 92 cetuximab on days 50, 57, 64, 71, 78, 85, 92, 99, and 106) 4 (Chemo and high dose 74 Gy - paclitaxel and carboplatin on days 78 and 99 cetuximab on days 57, 64, 71, 78, 85, 92, 99, 106, and 113) 7 WAS DOSE MODIFIED DUE TO WEIGHT LOSS? (7) (skip to Q#8) (complete question 7a) 7a IF DOSE WAS MODIFIED (code all below using codetable from Q#7) DAY #50 (8) DAY #57 (9) DAY #64 (10) DAY #71 (11) DAY #78 (12) DAY #85 (13) DAY #92 (14) DAY #99 (15) DAY #106 (16) DAY #113 (17) 0617 SF of 7
2 SF Consolidation Summary Form AMENDED DATA YES RTOG Study No.0617 Case # AGENT NAME PACLITAXEL CARBOPLATIN CETUXIMAB 8 DATE STARTED (18) - - (29) - - (40) DATE STOPPED (19) - - (30) - - (41) DOSE SPECIFICATIONS (20) DAY #64 mg (21) DAY #71 mg (22) DAY #78 mg (23) DAY #85 mg (24) DAY #92 mg (25) DAY #99 mg (31) DAY #64 mg (32) DAY #71 mg (33) DAY #78 mg (34) DAY #85 mg (35) DAY #92 mg (36) DAY #99 mg (42) DAY #50 mg (43) DAY #57 mg (44) DAY #64 mg (45) DAY #71 mg (46) DAY #78 mg (47) DAY #85 mg (48) DAY #92 mg (49) DAY #99 mg (50) DAY #106 mg (51) DAY #113 mg (26) AGENT TOTAL CUMULATIVE DOSE mg (37) AGENT TOTAL CUMULATIVE DOSE mg (52) AGENT TOTAL CUMULATIVE DOSE mg 11 DOSE MODIFICATION (CHANGE) (If yes, specify in comments) 0 Not applicable 1 Yes, planned, unplanned 3 No (27) (38) (53) 12 REASON TREATMENT ENDED (Use codetable from below) (28) (39) (54) REASON FOR TERMINATION 1 Treatment completed per protocol criteria 2 Disease progression, relapse during active treatment 3 Adverse events/side effects/complications (must code specific AE MedDRa code in Q#13) 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 (55) 98 Other, specify (56) (COMPLETE BELOW IF Q#12 CODED "3") 13 SPECIFY AE(s) THAT CAUSED TREATMENT TERMINATION. USE VERSION 3.0 MedDRA 9.0. ANY MedDRA CODE RECORDED BELOW MUST BE DETAILED IN Q#14 OR Q#15. MedDRA AE CODE (57) (58) (59) (60) 0617 SF of 7
3 SF Form - Consolidation Treatment Summary 14 Protocol Specific Adverse Event Evaluation Score all grades observed during this report period. Record all additional occurrences within this report period in Q#15. Use the CTCAE version 3.0 (MedDRA 9.0) to code all events. All toxicities must be graded. If none code 0. Do not leave blank. AE s require date of onset and resolution date (if applicable). A, B, C, D, E, F, and G must be coded. A. ATTRIBUTION CODE ANY PROTOCOL TREATMENT (Including investigational agent) 1 Unrelated 2 Unlikely 3 Possible 4 Probable 5 Definite TERM B. HAS AN ADEERS BEEN FILED 9 Unknown MedDRA AE CODE C. WAS THIS A SAE PER NCI DEFINITIONS (See table on page 5)? GRADE BEGIN DATE END DATE - - (62) - - (72) - - (82) - - (92) - - (102) - - (122) - - (132) - - (152) RTOG Protocol No Case # Institution Participant's Initials Participant's I.D. No. F. TREATMENT REQUIRED? ne 2 Concomitant medication 3 Procedural surgery Dry Skin ( ) (61) - - (63) (64) (65) (66) (67) (68) (69) (70) Nail Changes ( ) (71) - - (73) (74) (75) (76) (77) (78) (79) (80) Pruritis/Itching ( ) (81) - - (83) (84) (85) (86) (87) (88) (89) (90) Rash/desquamation ( ) (91) - - (93) (94) (95) (96) (97) (98) (99) (100) Rash:acne/ acneiform ( ) (101) - - (103) (104) (105) (106) (107) (108) (109) (110) Rash: dermatitis associated radiation - - (112) Select: Radiation ( ) (111) - - (113) (114) (115) (116) (117) (118) (119) (120) Select: Chemoradiation ( ) (121) - - (123) (124) (125) (126) (127) (128) (129) (130) Weight loss ( ) (131) - - (133) (134) (135) (136) (137) (138) (139) (140) Fever (In the absence of neutropenia, where neutropenia is defined as ANC < 1.0 x 10^9/L) - - (142) D. IS THERE A REASONABLE POSSIBILITY THAT THE EVENT MAY HAVE BEEN CAUSED BY THE INVESTIGATIONAL AGENT? E. ACTION TAKEN REGARDING STUDY THERAPY dose modification 2 Dose reduced 3 Drug interrupted 4 Drug discontinued 5 Dose delayed/omitted 6 IV Rate decreased A B C D E F G G. PRESENT STATUS t recovered/not resolved 2 Recovered/Resolved with 3 Recovered/Resolved without ( ) (141) - - (143) (144) (145) (146) (147) (148) (149) (150) Pain- Head/headache ( ) (151) - - (153) (154) (155) (156) (157) (158) (159) (160) Allergic reaction/hypersensitivity - - (162) (including drug fever) ( ) (161) - - (163) (164) (165) (166) (167) (168) (169) (170) 0617 SF of 7
4 15 (171) ANY OTHER TREATMENT RELATED ADVERSE EVENTS? 9 Unknown A. ATTRIBUTION CODE ANY PROTOCOL TREATMENT (Including investigational agent) 1 Unrelated 2 Unlikely 3 Possible 4 Probable 5 Definite MedDRA AE CODE Adverse Events: All multiple occurring AE s with varying grades must be recorded (grade 1-5). Use the CTCAE version 3.0 (MedDRA 9.0) to code all events. AE s require date of onset and resolution date (if applicable). A, B, C, D, E, F, and G must be coded. B. HAS AN ADEERS BEEN FILED 9 Unknown CTC ADVERSE EVENT TERM SF Form - Consolidation Treatment Summary C. WAS THIS A SAE PER NCI DEFINITIONS (See table on page 5)? GRADE D. IS THERE A REASONABLE POSSIBILITY THAT THE EVENT MAY HAVE BEEN CAUSED BY THE INVESTIGATIONAL AGENT? BEGIN DATE END DATE - - (304) - - (316) - - (328) - - (340) - - (352) - - (364) - - (376) - - (388) - - (400) - - (412) - - (424) RTOG Protocol No Case # Institution Participant's Initials Participant's I.D. No. F. TREATMENT REQUIRED? ne 2 Concomitant medication 3 Procedural surgery E. ACTION TAKEN REGARDING STUDY THERAPY dose modification 2 Dose reduced 3 Drug interrupted 4 Drug discontinued 5 Dose delayed/omitted 6 IV Rate decreased G. PRESENT STATUS t recovered/not resolved 2 Recovered/Resolved with 3 Recovered/Resolved without A B C D E F G (301) (302) (303) - - (305) (306) (307) (308) (309) (310) (311) (312) (313) (314) (315) - - (317) (318) (319) (320) (321) (322) (323) (324) (325) (326) (327) - - (329) (330) (331) (332) (333) (334) (335) (336) (337) (338) (339) - - (341) (342) (343) (344) (345) (346) (347) (348) (349) (350) (351) - - (353) (354) (355) (356) (357) (358) (359) (360) (361) (362) (363) - - (365) (366) (367) (368) (369) (370) (371) (372) (373) (374) (375) - - (377) (378) (379) (380) (381) (382) (383) (384) (385) (386) (387) - - (389) (390) (391) (392) (393) (394) (395) (396) (397) (398) (399) - - (401) (402) (403) (404) (405) (406) (407) (408) (409) (410) (411) - - (413) (414) (415) (416) (417) (418) (419) (420) (421) (422) (423) - - (425) (426) (427) (428) (429) (430) (431) (432) 0617 SF of 7
5 SF Form - Consolidation Treatment Summary SF RTOG Protocol No Case # MedDRA AE CODE CTC ADVERSE EVENT TERM GRADE BEGIN DATE END DATE Institution Participant's Initials Participant's I.D. No. A B C D E F G - - (436) - - (448) - - (460) - - (472) - - (484) - - (496) - - (508) - - (520) - - (532) (433) (434) (435) - - (437) (438) (439) (440) (441) (442) (443) (444) (445) (446) (447) - - (449) (450) (451) (452) (453) (454) (455) (456) (457) (458) (459) - - (461) (462) (463) (464) (465) (466) (467) (468) (469) (470) (471) - - (473) (474) (475) (476) (477) (478) (479) (480) (481) (482) (483) - - (485) (486) (487) (488) (489) (490) (491) (492) (493) (494) (495) - - (497) (498) (499) (500) (501) (502) (503) (504) (505) (506) (507) - - (509) (510) (511) (512) (513) (514) (515) (516) (517) (518) (519) - - (521) (522) (523) (524) (525) (526) (527) (528) (529) (530) (531) - - (533) (534) (535) (536) (537) (538) (539) (540) NCI SAE DEFINITION * Death * A life-threatening adverse drug experience; * Inpatient hospitalization or prolongation of existing hospitalization; * A persistent or significant disability/incapacity; * A congenital anomaly/birth defect 0617 SF of 7
6 SF Consolidation Summary Form UNITS(541) 1 Conventional (use flowsheet below) 2 SI (skip to Q#17 flowsheet) AMENDED DATA YES RTOG Study No.0617 Case # 16 INSTRUCTIONS: Record laboratory values USING STANDARD U.S. UNITS and normal ranges. See protocol for lab schedules Grade lab abnormalities on page 4 and/or 5. 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) Investigator Signature - - (1276) Date 0617 SF of 7
7 SF Consolidation Summary Form AMENDED DATA YES RTOG Study No.0617 Case # 17 INSTRUCTIONS: Record laboratory values USING STANDARD INTERNATIONAL UNITS and normal ranges. See protocol for lab schedules Grade lab abnormalities on page 4 and/or 5. 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) Investigator Signature - - (1841) Date 0617 SF of 7
B. PANITUMUMAB DOSE LEVEL 0 No dose reduction 1 Level -1 2 Level Other, specify in comments for this cycle
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