HD 18 for advanced stages: treatment optimization trial in the first line treatment of advanced stage Hodgkin Lymphoma; treatment stratification by means of FDG-PET. - HD 18
Phase 1
- Conditions
- Hodgkin's Lymphoma advanced stage
- Registration Number
- EUCTR2007-003187-22-NL
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2101
Inclusion Criteria
- Hodgkin Lymfoma
- First diagnosis, no previous treatment, histologically proven
- Age: 18-60 years
- Stage IIB with large mediastinal mass or extranodal lesions, stage III or IV.
Are the trial subjects under 18? no
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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- composite lymphoma
- previous malignancy
- prior chemotherapy or radiation
- concurrent disease which precludes protocol treatment
- pregnancy, lactation
- non-compliance
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: The diagnostic value of a FDG-PET examination that is performed after 2 cycles of escalated BEACOPP is to be determined.;Primary end point(s): Progression Free survival (PFS)<br>;Main Objective: To individualize treatment for each patient by adapting it to early response after 2 cycles of escalated BEACOPP and thus to continue intensive treatment only with those patients who show an inadequate treatment response.<br>For patients with adequate response, the intensity of treatment is to be reduced while its efficacy should be maintained at the same high level.
- Secondary Outcome Measures
Name Time Method