Status:
UNKNOWN
Fludeoxyglucose F 18 PET Scan-Guided Therapy or Standard Therapy in Treating Patients With Previously Untreated Stage I or Stage II Hodgkin's Lymphoma
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborating Sponsors:
Lymphoma Study Association
Fondazione Italiana Linfomi - ETS
Conditions:
Lymphoma
Eligibility:
All Genders
15-70 years
Phase:
PHASE3
Brief 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 c...
Detailed Description
OBJECTIVES: Primary * Evaluate whether chemotherapy alone is as effective, but less toxic, as combined modality treatment, in terms of progression-free survival (PFS), in patients with favorable or ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1952 Patients enrolled
Trial Details
Trial ID
NCT00433433
Start Date
October 1 2006
Last Update
February 3 2021
Active Locations (1)
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1
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, Netherlands, NL-6500 HB