Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00002840

Collaborator

Medical Research Council (Other)

350

Enrollment

Locations

8.8

Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, and may be an effective treatment for anaplastic oligodendroglioma. Combining combination chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare radiation therapy with and without combination chemotherapy in patients with resected anaplastic oligodendroglioma.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: lomustine Drug: procarbazine hydrochloride Drug: vincristine sulfate Radiation: radiation therapy	Phase 3

Detailed Description

OBJECTIVES: I. Compare survival and time to first progression in patients with anaplastic oligodendroglioma treated with radiotherapy with or without adjuvant procarbazine, lomustine, and vincristine (PCV) following surgical resection. II. Investigate the effect of PCV on quality of life and neurologic function in these patients. III. Determine the toxicity of PCV in these patients. IV. Correlate chromosomal lesions (1p and/or 19q, 9p, p53 loss and mutation, amplification of chromosome 7, or loss of chromosome 10) with progression-free and overall survival in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age, extent of resection, performance status, prior surgery, and participating center. Patients are randomized to one of two treatment arms. Arm I: Within 4-6 weeks after surgery, patients undergo radiotherapy over 7 weeks to the residual tumor volume. Arm II: Patients undergo radiotherapy as in arm I, then begin chemotherapy within 4 weeks after the completion of radiotherapy. Patients receive oral lomustine on day 1, oral procarbazine on days 8-21, and vincristine IV on days 8 and 29. Treatment repeats every 6 weeks in stable and responding patients for a total of 6 courses. Patients with disease recurrence may receive 6 additional courses of chemotherapy as above or another modality at the investigator's discretion. Patients are followed every 3 months for 1 year and then every 6 months for survival.

PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 4 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

PHASE III STUDY OF ADJUVANT PROCARBAZINE, CCNU AND VINCRISTINE CHEMOTHERAPY IN PATIENTS WITH HIGHLY ANAPLASTIC OLIGODENDROGLIOMA

Study Start Date :

Aug 1, 1996

Actual Primary Completion Date :

Mar 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Newly diagnosed oligodendroglioma or oligoastrocytoma (with at least 25% oligodendral elements) Low-grade oligodendroastrocytoma or oligodendroglioma that is recurrent after surgery without radiotherapy is allowed Prior partial or gross total resection of tumor (or biopsy only in case of no further surgical option) required At least 3 of the following histologic anaplastic features: High cellularity Endothelial abnormalities Nuclear abnormalities Necrosis Mitoses

PATIENT CHARACTERISTICS: Age: 16 to 69 Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.4 mg/dL Renal: Creatinine no greater than 1.3 mg/dL Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception No active or uncontrolled infection No other disease, including malignancy, that would preclude study No neurologic or psychiatric disturbance that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to the skull Surgery: See Disease Characteristics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Franz Josef Hospital	Vienna (Wien)		Austria	A-1100
2	Academisch Ziekenhuis der Vrije Universiteit Brussel	Brussels (Bruxelles)		Belgium	1090
3	Hopital Universitaire Erasme	Brussels		Belgium	1070
4	Hopital de Jolimont	Haine Saint Paul		Belgium	7100
5	U.Z. Gasthuisberg	Leuven		Belgium	B-3000
6	Turku University Central Hospital	Turku		Finland	FIN-2-0521
7	Centre Hospitalier Regional de Lille	Lille		France	59037
8	CHU de la Timone	Marseille		France	13385
9	CHU de Nancy - Hopital Neurologique	Nancy		France	54035
10	CRLCC Nantes - Atlantique	Nantes-Saint Herblain		France	44805
11	Hopital Pasteur	Nice		France	06002
12	Centre Antoine Lacassagne	Nice		France	06189
13	C.H.R. de Nimes - Hopital Caremeau	Nimes		France	30000
14	CHU Pitie-Salpetriere	Paris		France	75651
15	Centre Eugene Marquis	Rennes		France	35064
16	Institut Gustave Roussy	Villejuif		France	F-94805
17	Neurologische Klinik der Henriettenstiftung	Hannover		Germany	D-30559
18	Klinikum der Friedrich-Schiller Universitaet Jena	Jena		Germany	D-07740
19	National Institute of Neurosurgery	Budapest		Hungary	1145
20	Azienda Ospedaliera di Padova	Padova (Padua)		Italy	35128
21	Universita di Padova	Padova		Italy	35128
22	Medisch Centrum Haaglanden	's-Gravenhage (Den Haag, The Hague)		Netherlands	2501 CK
23	Vrije Universiteit Medisch Centrum	Amsterdam		Netherlands	1001HV
24	Academisch Medisch Centrum	Amsterdam		Netherlands	1105 AZ
25	Academisch Ziekenhuis Groningen	Groningen		Netherlands	9713 EZ
26	University Medical Center Nijmegen	Nijmegen		Netherlands	NL-6500 HB
27	Rotterdam Cancer Institute	Rotterdam		Netherlands	3075 EA
28	St. Elisabeth Ziekenhuis	Tilburg		Netherlands	5022 GC
29	Dr. Bernard Verbeeten Instituut	Tilburg		Netherlands	5042 SB
30	Academisch Ziekenhuis Utrecht	Utrecht		Netherlands	3584 CX
31	Instituto Portugues de Oncologia de Francisco Gentil	Lisbon		Portugal	1093
32	University Hospital of Linkoping	Linkoping		Sweden	S-581 85
33	Umea Universitet	Umea		Sweden	S-901 85
34	Centre Hospitalier Universitaire Vaudois	Lausanne		Switzerland	CH-1011
35	Nottingham General Hospital	Nottingham	England	United Kingdom	NG1 6HA
36	Nottingham City Hospital NHS Trust	Nottingham	England	United Kingdom	NG5 1PB
37	Queen's Medical Centre	Nottingham	England	United Kingdom	NG7 2UH
38	Royal South Hants Hospital	Southampton	England	United Kingdom	SO14 0YG
39	Southampton General Hospital	Southampton	England	United Kingdom	SO16 6YD
40	Royal Marsden Hospital	Sutton	England	United Kingdom	SM2 5PT