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

• Status: Active, not recruiting
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborators: Fondazione Italiana Linfomi ONLUS; Lymphoma Study Association
• Treatments: Fluorodeoxyglucose F18

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed Hodgkin's lymphoma

• No nodular lymphocyte-predominant subtype (nodular paragranuloma)

• Supradiaphragmatic Ann Arbor clinical stage I or II disease

• Must meet criteria for 1 of the following prognostic subsets:

• Unfavorable subset, defined as meeting 1 of the following criteria:

• Clinical stage II disease with ≥ 4 nodal areas involved

• Mediastinum and hili are considered as 1 nodal area

• Age ≥ 50 years

• Erythrocyte sedimentation rate (ESR) ≥ 50 mm/hr with no B symptoms

• ESR ≥ 30 mm/hr with B symptoms

• Mediastinum/thoracic (MT) ratio ≥ 0.35

• Favorable subset, defined as meeting all of the following criteria:

• Clinical stage I disease OR stage II disease with ≤ 3 involved areas

• Age < 50 years

• ESR < 50 mm/hr (no B symptoms) OR ESR < 30 mm/hr (B symptoms present)

• MT ratio < 0.35

• Previously untreated disease

• Planning to undergo fludeoxyglucose F 18 positron emission tomography after the first 2 courses of study chemotherapy

PATIENT CHARACTERISTICS:

• WHO performance status 0-3

• Bilirubin ≤ 2.5 times upper limit of normal (ULN)

• Creatinine ≤ 2.5 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No severe cardiac, pulmonary, neurologic, psychiatric, or metabolic disease

• No unstable diabetes mellitus

• No other malignancies within the past 5 years except for basal cell skin cancer or adequately treated carcinoma in situ of the cervix

• No known HIV infection

• No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• Not specified