(7) VITAL SIGNS (8) LEVEL OF CONSCIOUSNESS (9) MENTAL STATUS (10) SPEECH (11) VISION (12) FUNDUS (PAPILLEDEMA)
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1 Radiation Therapy Oncology Group Phase II CNS Lymphoma Follow-Up Form RTOG Study No Case # Amended Data Yes INSTRUCTIONS: Submit this form as indicated in the protocol. All dates need to be recorded as mm-dd-yyyy unless otherwise specified DATE OF LAST CONTACT OR DEATH(1) mm-dd-yyyy 2 (2) PATIENT VITAL STATUS 1 Alive 2 Dead 3 (3) CAUSE OF DEATH 1 Primary intracranial lymphoma 2 Radiotherapy related neurotoxicity 3 Leptomeningeal dissemination 4 Both primary intracranial lymphoma and leptomeningeal dissemination 5 Disseminated lymphoma outside CNS 6 CNS lymphoma and disseminated lymphoma outside CNS 7 Complications of protocol therapy * 8 Complications of other therapy * 9 Other, specify * 10 Unknown * specify (4) 4 (5) KARNOFSKY PERFORMANCE STATUS 5 (6) NEUROLOGICAL FUNCTION 0 No neurological symptoms; fully active at home/ work without assistance 1 Minor neurological symptoms; fully active at home/work without assistance 2 Moderate neurological symptoms; fully active at home/work but requires assistance 3 Moderate neurologic symptoms; less than fully active at home/work and requires assistance 4 Severe neurologic symptoms; totally inactive requireing complete assistance at home or in institution; unable to work 6 NEUROLOGICAL ASSESSMENT 0 Normal 1 Slightly or minimally abnormal 2 Moderately abnormal 3 Severely or markedly abnormal 4 Unable to evaluate (7) VITAL SIGNS (8) LEVEL OF CONSCIOUSNESS (9) MENTAL STATUS (10) SPEECH (11) VISION (12) FUNDUS (PAPILLEDEMA) (13) CRANIAL NERVES (Specify CN # if abnormal) CN # (14) (15) MOTOR FUNCTION (16) SENSORY FUNCTION (17) GAIT OR LIMB ATAXIA 7 OTHER EVALUATIONS 0 Not done 1 Negative 2 Positive *Specify 3 Equivocal (18) OPTHALMOLOGIC EXAM DATE - - (19) specify (20) (21) LUMBAR PUNCTURE DATE - - (22) specify (23) 1114 F1a of 6
2 8 RECURRENT DISEASE(24), complete SR Form 3 Unknown IF YES, PLEASE SPECIFY PATERN OF RECURRENCE: (25) 1 Brain 2 Spinal cord 3 CSF 4 Eyes 5 Systemic lymphoma 6 Combination of the above specify (26) 9 SINCE THE LAST VISIT, HAS THE PATIENT RECEIVED ANY NON-PROTOCOL CANCER THERAPY NOT PREVIOUSLY REPORTED? (27) (if no, skip to Q11) (if yes Q10 a-g must be answered) (skip to Q11) 10a EXTENT OF RESECTION (28) 0 Not applicable 1 Biopsy 2 Subtotal 3 Total (gross) 4 Other, specify (29) - - DATE OF RESECTION(30) if yes to Surgery, enter pathology findings at surgery WAS THERE GROSS EVIDENCE OF TUMOR?(31) 0 Undetermined 10b NON-PROTOCOL WHOLE- BRAIN RADIATION THERAPY (33) - - Non-Protocol RADIATION THERAPY START DATE (34). (Gy)TOTAL DOSE OF RADIATION THERAPY(35) OTHER TYPE OF RADIATION THERAPY (36) If yes, specify (37) 10c NON-PROTOCOL CHEMOTHERAPY(38) 10d CORTICOSTEROIDS(39) Specify (40) Date of last dose - - (41) WAS RT NECROSIS PRESENT?(32) 0 Undetermined 1114 F1a of 6
3 11 SYSTEMIC MANAGEMENT (42) CORTICOSTEROID, - - Date of Initial Dose(43) Specify Drug (44) (45) ANTICONVULSANT, - - Date of Initial Dose(46) Specify Drug (47) (48) CHEMOTHERAPY Specify Drug 1 (49) - - Date of Initial Dose(50) Specify Drug 2 (51) - - Date of Initial Dose(52) Specify Drug 3 (53) - - Date of Initial Dose(54) Specify Drug 4 (55) - - Date of Initial Dose(56) Specify Drug 5 (57) - - Date of Initial Dose(58) (59) STEM CELL TRANSPLANT (60) OTHER, Specify (61) - - Date of Initial Dose(62) 12 (63) IN THE INVESTIGATOR'S OPINION, HAS THE PATIENT EXPERIENCED NEUROTOXICITY, DEFINED AS SEVERE COGNITIVE DETERIORATION IN COMPARISON TO POST-TREATMENT BASELINE, ACCOMPANIED BY PSYCHOMOTOR SLOWNESS AND GAIT ATAXIA AND THAT CANNOT BE ACCOUNTED FOR BY DISEASE RECURRENCE? If yes, define (64) 1114 F1a of 6
4 13 ANY ADDITIONAL ADVERSE EVENTS?(65) Adverse Events: Use the CTCAE version 4.0 MedDRA 12.0 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. CTC AE Attribution Code 1 Unrelated 2 Unlikely 3 Possible 4 Probable 5 Definite B. SAE Report Submitted MeDRA Disease Code CTC Adverse Event Term CTC AE CTC AE Begin Date Grade 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) (396) (397) (398) (399) - - (400) (401) (402) (403) (404) (405) - - (406) (407) (408) (409) (410) (411) - - (412) (413) (414) 1114 F1a of 6
5 UNITS(601) 1 Conventional (use flowsheet below) 2 SI (skip to Q#13 flowsheet) 14 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 ( )(1277) The reported case report information has been reviewed and confirmed by the principal investigator. (1275) Investigator Signature - - (1276) Date 1114 F1a of 6
6 15 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 1114 F1a of 6
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