Surgery Alone, Surgery With Cyclophosphamide, Vinblastine, and Prednisolone (CVP), or CVP Alone in Treating Young Patients With Stage IA or Stage IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma
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.
Drug: vinblastine sulfate
Other: watchful waiting
Procedure: therapeutic conventional surgery
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents|
- Event-free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Significant upstaging at relapse defined as development of B-symptoms, extranodal disease, or relapse higher than stage II [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Complications of surgery [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
watch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL
|Other: watchful waiting Procedure: therapeutic conventional surgery|
3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone)
Other Name: CYCDrug: prednisolone Drug: vinblastine sulfate
Other Name: VBL
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088750
|Contact: Dieter Koerholz, MDfirstname.lastname@example.org|
|Contact: Christine Mauz-Koerholz, MDemail@example.com|
|Giessen, Germany, D-35385|
|Contact: Contact Person 0049-641-985- ext 57921 firstname.lastname@example.org|
|Contact: Christine Mauz-Koerholz, MD email@example.com|
|Principal Investigator:||Dieter Koerholz, MD||Universitaetsklinikum Giessen und Marburg|