Radiation Therapy Oncology Group Phase II - SBRT - Medically Inoperable I /II NSCLC Follow-up Form RTOG Study No. 0813 Case # Name RTOG Patient ID INSTRUCTIONS: Submit this form at the appropriate followup interval and whenever there is a change in the patient's status. Dates are mm-dd-yyyy unless otherwise specified. 1 (1) VITAL STATUS 1 Alive 2 Dead 2 (2) - - DATE OF LAST CONTACT OR DEATH 3 (3) PRIMARY CAUSE OF DEATH 1 Due to this disease (whether local, regional, or distant) 2 Due to a second primary or other malignancy 3 Due to protocol treatment (explain in COMMENTS, requires a grade 5 toxicity code) 4 Due to other cause (describe cause of death in comment section) 5a (6) RESPONSE OF TARGET LESION AT THIS ASSESSMENT (TARGET VOLUME ONLY) 1 Complete Response (CR) 2 Partial Response (PR) 3 Stable Disease (SD) 4 Local Enlargement (LE) 5 Primary tumor failure (PTF) 6 Not evaluated 5b RESPONSE CONFIRMED DATE - - (7) 6 STATUS OF LESIONS OUTSIDE OF TARGET VOLUME(8) 0 Not evaluated 1 Disease present, answer all 4 items in 6b 2 Disease absent 6b STATUS DATE CONFIRMED 4a (4). kg WEIGHT 4b (5) PERFORMANCE STATUS (ZUBROD)(0-5, 9=Unknown) Marginal Failure (MF)(9) Involved lobe failure(100) Regional Failure (RF)(11) Metastatic Dissemination (MD)(13) - - (10) - - (101) - - (12) - - (14) 7 HAS PATIENT BEEN DIAGNOSED WITH A NEW PROGRESSION? (From this primary lung tumor) PROGRESSION 0 Not evaluated METHOD OF EVALUATION 0 Not applicable 1 Physical Exam 2 CT Scan 3 MRI Scan 4 PET Scan 5 Pathologic 6 Chest x-ray SITE OF PROGRESSION #1 #2 (15) Lung (Primary Site) (16) (17) (19) Lung (Primary, margin or stump) (20) (21) (23) Ipsilateral lung (Not primary site) (24) (25) (27) Contralateral lung (28) (29) (31) Regional lymph nodes (32) (33) (35) Pleura (36) (37) (39) Brain (40) (41) (43) CNS (Not brain) (44) (45) (47) Liver (48) (49) (51) Bone (52) (53) (55) Distant lymph nodes, specify(56) (57) (58) (60) Skin or subcutaneous, specify(61) (62) (63) (65) Other site, specify(66) (67) (68) DATE RESPONSE LAST DOCUMENTED (18) - - (22) - - (26) - - (30) - - (34) - - (38) - - (42) - - (46) - - (50) - - (54) - - (59) - - (64) - - (69) - - 0813 F1a 09-30-10 1 of 5
8 HAS A NEW PRIMARY CANCER OR MDS (MYELODYSPLASTIC SYNDROME) BEEN DIAGNOSED THAT HAS NOT BEEN PREVIOUSLY REPORTED?(70) NEW PRIMARY SITE 11 Oral cavity 12 Oropharynx 13 Hypopharynx 14 Larynx 15 Nasopharynx 16 Other H + N 17 AML/MDS 18 BCC 19 Bladder 20 Brain 21 Colorectal 22 Esophageal 23 Gastric 24 Liver 25 Lung 26 Melanoma 27 NHL 28 Pancreatic 29 Renal 30 Squamous-Skin 31 Prostate 32 Other Hematologic 33 Other solid 34 Unknown primary METHOD OF EVALUATION 1 Physical Exam 2 CT Scan 3 MRI Scan 4 PET Scan 5 Pathologic 6 Chest x-ray SITES(S) OF NEW PRIMARY METHOD OF EVALUATION DATE OF DIAGNOSIS (71) (72) - - (73) (74) (75) - - (76) (77) (78) - - (79) 9 (80) WERE PULMONARY FUNCTION TESTS PERFORMED? Date - - (81) (82). BEST FORCED EXPIRATORY VOLUME 1 (FEV 1) L/SEC (83). % OF PREDICTED VALUE (FEV 1) (84). % OF CARBON MONOXIDE DIFFUSION (DLCO) (85). FORCED VITAL CAPACITY (FVC) L/sec (86). % OF PREDICTED FORCED VITAL CAPACITY 10 (87) IS THE PATIENT RECEIVING ANY NON-PROTOCOL CANCER THERAPY NOT PREVIOUSLY REPORTED? (code all boxes) (88) PCI (89) Non-Protocol Radiation Therapy (excluding PCI) (90) Non-Protocol Surgery (91) Non-Protocol Chemotherapy (92) Other Non-Protocol therapy (specify below): (93) 0813 F1a 09-30-10 2 of 5
11 PROTOCOL SPECIFIC EVENTS DURING THIS PERIOD (94) (All events below must be coded) Protocol Specific Adverse Event Evaluation. Score most severe grade observed during report period (Grade 1-5). If the AE did not occur, code "0".. AE's > grade 3 require date of onset.. Assign attribution to protocol treatment for each AE reported; indicate whether SAE was submitted A. Attribution to Protocol Treatment 1 Unrelated 2 Unlikely 3 Possible 4 Probable 5 Definite B. SAE Report Submitted MedDRA 12 ADVERSE EVENT CODE CTCAE V4 TERM GRADE START DATE A B 1 0 0 3 4 4 7 4 1 0 0 3 4 4 8 4 1 0 0 3 8 7 4 8 1 0 0 1 3 9 5 0 1 0 0 1 5 4 6 1 1 0 0 6 5 8 5 1 (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) 1 0 0 1 5 3 8 7 1 0 0 5 5 4 7 2 1 0 0 1 5 4 4 8 1 0 0 1 5 4 5 1 1 0 0 1 5 3 8 4 1 0 0 6 5 4 1 7 1 0 0 3 8 1 3 0 1 0 0 2 8 5 2 4 1 0 0 0 3 5 9 8 1 0 0 2 1 1 4 3 1 0 0 3 5 5 9 8 1 0 0 3 5 7 4 2 1 0 0 3 7 3 8 3 1 0 0 6 5 7 4 6 Pericardial effusion Pericarditis Restrictive cardiomyopathy Dysphagia Esophagitis Esophageal fistula Esophageal obstruction (337) (338) (339) - - (340) (341) (342) Esophageal perforation (343) (344) (345) - - (346) (347) (348) Esophageal stenosis (349) (350) (351) - - (352) (353) (354) Esophageal ulcer (355) (356) (357) - - (358) (359) (360) Esophageal hemorrhage (361) (362) (363) - - (364) (365) (366) Brachial plexopathy (367) (368) (369) - - (370) (371) (372) Recurrent laryngeal nerve palsy (373) (374) (375) - - (376) (377) (378) Myelitis (379) (380) (381) - - (382) (383) (384) Atelectasis (391) (392) (393) - - (394) (395) (396) Hypoxia (397) (398) (399) - - (400) (401) (402) Pleural effusion (403) (404) (405) - - (406) (407) (408) Pneumonitis (409) (410) (411) - - (412) (413) (414) Pulmonary fibrosis (415) (416) (417) - - (418) (419) (420) Bronchopulmonary hemorrhage (421) (422) (423) - - (424) (425) (426) 0813 F1a 09-30-10 3 of 5
MedDRA 12 ADVERSE EVENT CODE CTCAE V4 TERM GRADE START DATE A B 1 0 0 5 6 3 5 6 1 0 0 5 5 3 1 9 1 0 0 6 2 5 4 8 1 0 0 0 6 4 3 7 1 0 0 6 5 8 7 3 1 0 0 5 3 4 8 1 1 0 0 6 5 7 8 7 1 0 0 0 6 4 4 0 1 0 0 4 4 2 9 1 Mediastinal hemorrhage (439) (440) (441) - - (442) (443) (444) Pleural hemorrhage (445) (446) (447) - - (448) (449) (450) Tracheal hemorrhage (457) (458) (459) - - (460) (461) (462) Bronchial fistula (463) (464) (465) - - (466) (467) (468) Pulmonary fistula (469) (470) (471) - - (472) (473) (474) Bronchopleural fistula (475) (476) (477) - - (478) (479) (480 Tracheal fistula (481) (482) (483) - - (484) (485) (486) Bronchial obstruction (487) (488) (489) - - (490) (491) (492) Tracheal obstruction (493) (494) (495) - - (496) (497) (498) 0813 F1a 09-30-10 4 of 5
12 ANY OTHER TREATMENT RELATED ADVERSE EVENTS?(95) 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 to Protocol Treatment 1 Unrelated 2 Unlikely 3 Possible 4 Probable 5 Definite B. SAE Report Submitted Adverse Event Code CTCAE V4 Term Grade Start Date A B (499) (500) (501) - - (502) (503) (504) (505) (506) (507) - - (508) (509) (510) (511) (512) (513) - - (514) (515) (516) (517) (518) (519) - - (520) (521) (522) (523) (524) (525) - - (526) (527) (528) (529) (530) (531) - - (532) (533) (534) (535) (536) (537) - - (538) (539) (540) (541) (542) (543) - - (544) (545) (546) (547) (548) (549) - - (550) (551) (552) (553) (554) (555) - - (556) (557) (558) (559) (560) (561) - - (562) (563) (564) (565) (566) (567) - - (568) (569) (570) (571) (572) (573) - - (574) (575) (576) (577) (578) (579) - - (580) (581) (582) (583) (584) (585) - - (586) (587) (588) (589) (590) (591) - - (592) (593) (594) (595) (596) (597) - - (598) (599) (600) (601) (602) (603) - - (604) (605) (606) (607) (608) (609) - - (610) (611) (612) Comments (96-97) - - Signature of person completing this form (98) Date form originally completed (99) 0813 F1a 09-30-10 5 of 5