Fludeoxyglucose F 18 PET Scan-Guided Therapy or Standard Therapy in Treating Patients With Previously Untreated Stage I or Stage II Hodgkin's Lymphoma

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET scan), may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET scan-guided therapy is more effective than standard therapy in treating Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying FDG-PET scan-guided therapy to see how well it works compared with standard therapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.

Conditions

• Lymphoma

Interventions

DRUG

ABVD q4 weeks

Doxorubicin 25 mg/m2 i.v. day 1 and 15; Bleomycin 10 mg/m2 i.v./i.m. day 1 and 15; Vinblastine 6 mg/m2 i.v. day 1 and 15; Dacarbazine 375 mg/m2 i.v. day 1 and 15

DRUG

BEACOPP escalated q3 weeks

Cyclophosphamide 1250 mg/m2 i.v. day 1; Doxorubicin 35 mg/m2 i.v. day 1; Vincristine 1.4 mg/m2 i.v.(max.2mg) day 8; Bleomycin 10 mg/m2 i.v./i.m. day 8; Etoposide 200 mg/m2/ i.v. day 1 to 3; Procarbazine 100 mg/m2 orally day 1 to 7; Prednisone 40 mg/m2 orally day 1 to 14; G-CSF 5 mcg/kg s.c. day 9 to recovery leukocytes\>1.0x109/l

RADIATION

IN-RT 30 Gy (+ boost 6 Gy residual)

PROCEDURE

FDG-PET scan

Sponsors & Collaborators

• Lymphoma Study Association

  collaborator OTHER

• Fondazione Italiana Linfomi - ETS

  collaborator OTHER

• European Organisation for Research and Treatment of Cancer - EORTC

  lead NETWORK

Principal Investigators

• John Raemaekers, MD, PhD · EORTC - Universitair Medisch Centrum St. Radboud, Nijmegen, NL

• H. Eghbali, MD · EORTC - Institut Bergonie, Bordeaux, FR

• Marc Andre, MD · GELA - Centre Hospitalier Notre Dame - Reine Fabiola, Brussels, BE

• Oumedaly Reman, MD · GELA - CHU de Caen, Caen, FR

• Massimo Federico, MD · GIMEMA- Azienda Ospedaliera - Universitaria di Modena, Modena, IT

• Ercole Brusamolino, MD · GIMEMA - Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, IT

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-10-31

Primary Completion

2011-12-31

Countries

• Netherlands

Study Locations