Surgery Alone or With CYC VBL and PRED or CVP Alone in Stage IA or IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma
- Conditions
- Lymphoma
- Interventions
- Other: watchful waitingProcedure: therapeutic conventional surgery
- Registration Number
- NCT01088750
- Lead Sponsor
- Christine Mauz-Körholz
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, vinblastine, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Surgery to remove involved lymph nodes may be an effective treatment for young patients with nodular lymphocyte-predominant Hodgkin lymphoma.
PURPOSE: This phase IV trial is continuing to study the side effects of giving surgery alone or giving surgery with cyclophosphamide, vinblastine, and prednisolone compared with giving cyclophosphamide, vinblastine, and prednisolone alone in treating young patients with stage IA or stage IIA nodular lymphocyte-predominant Hodgkin lymphoma.
- Detailed Description
OBJECTIVES:
Primary
* Determine the 5-year event-free survival of children or adolescents with stage IA or IIA nodular lymphocyte-predominant Hodgkin lymphoma treated with surgery alone or with cyclophosphamide, vinblastine, and prednisolone.
Secondary
* Determine if this regimen results in a decrease in overall survival rates, in significant upstaging at relapse, or increased rates of histological transformation in these patients.
OUTLINE:
* Group 1 (patients with stage IA disease only): Patients undergo surgical resection of the involved lymph nodes. Patients who achieve complete resection then enter follow-up (watch and wait); patients who do not achieve complete resection enters group 2 treatment.
* Group 2 (patients with stage IIA disease or incompletely resected stage IA disease): Patients receive cyclophosphamide, vinblastine, and prednisolone for 3 courses. Patients with good response enter follow-up (watch and wait). Patients without a good response are taken off protocol.
After completion of study treatment, patients are followed-up periodically.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description surgery alone therapeutic conventional surgery watch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL surgery alone watchful waiting watch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL CVP Chemotherapy vinblastine sulfate 3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone) CVP Chemotherapy cyclophosphamide 3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone) CVP Chemotherapy prednisolone 3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone)
- Primary Outcome Measures
Name Time Method Event-free survival 5 years Time from treatment start until relapse/progression, secondary malignancy or death
- Secondary Outcome Measures
Name Time Method Overall survival 5 years Time from treatment start until death
Common Toxicity criteria toxicity Levels of therapy elements 5 years Evaluation of AEs, SAEs atc. according to CTC
Complications of surgery 5 years Listing of surgical complications
Significant upstaging at relapse defined as development of B-symptoms, extranodal disease, or relapse higher than stage II 5 years Stage greater than IIA at relapse diagnosis
Trial Locations
- Locations (1)
Universitaetsklinikum Giessen-Marburg
🇩🇪Giessen, Germany