The H10 EORTC/GELA randomized Intergroup trial on early FDG-PET scan guided treatment adaptation versus standard combined modality treatment in patients with supradiaphragmatic stage I/II Hodgkin's lymphoma. - H10
- Conditions
- Hodgkin’s lymphomaMedDRA version: 8.1 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease
- Registration Number
- EUCTR2005-002765-37-SK
- Lead Sponsor
- Euopean Organisation of Research and Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1950
- Histologically proven Hodgkin’s lymphoma, except for the nodular lymphocyte predominant subtype (nodular paragranuloma)
- Supradiaphragmatic Ann Arbor clinical stage I or II, both favorable and unfavorable
prognostic subsets (for definition of favorable (F) and unfavorable (U), see at the end of this section)
- Previously untreated
- Age 15 through 70 years
- FDG-PET scan already prospectively planned after two cycles of ABVD for all patients
(see Appendix G).
- WHO performance status grades 0, 1, 2 or 3 (see Appendix B) during the whole duration of study treatment.
- Absence of severe cardiac, pulmonary, neurologic psychiatric or metabolic disease. Patients with unstable diabetes mellitus are excluded (to avoid uninterpretable FDG-PET scan).
- Adequate liver and renal function (total serum bilirubin = 2.5 x ULN, serum creatinine = 2.5 x ULN)
- No concomitant or previous malignancies with the exception of basal cell skin tumors, adequately treated carcinoma in situ of the cervix and any cancer that has been in complete remission for >5 years
- No known HIV infection
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate whether chemotherapy alone is as effective, but less toxic, as combined modality treatment, in patients with stage I/II Hodgkin’s lymphoma who are FDG-PET scan negative after two cycles of ABVD. This question will be addressed in the group of patients with favorable stages I/II disease (F) as well as in those with unfavorable stage I/II disease (U).;Secondary Objective: To evaluate whether chemotherapy with escalated BEACOPP improves the outcome of PET positive patients – after 2 cycles of chemotherapy - when compared with standard therapy;Primary end point(s): progression-free survival (PFS). PFS is defined as time interval form the date of randomization until documentation of first progression or death whichever comes first
- Secondary Outcome Measures
Name Time Method