Combination Chemotherapy and/or Radiation Therapy in Treating Young Patients With Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00417014|
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : December 28, 2006
Last Update Posted : August 2, 2013
RATIONALE: Drugs used in chemotherapy, such as chlorambucil, vinblastine, procarbazine, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy and/or radiation therapy works in treating young patients with Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment|
|Lymphoma||Drug: chlorambucil Drug: prednisolone Drug: procarbazine hydrochloride Drug: vinblastine sulfate Radiation: radiation therapy|
- Establish a uniform practice for the management of children with Hodgkin's lymphoma.
- Document the long-term side effects of such management.
- Establish whether or not children can be safely managed without staging laparotomy and splenectomy.
- Establish whether or not chlorambucil, vinblastine, procarbazine hydrochloride, and prednisolone (CLVPP) is an effective alternative to mechlorethamine, vincristine, procarbazine hydrochloride, and prednisone (MOPP) chemotherapy.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 treatment regimens according to disease stage and presence of bulky mediastinal disease.
- Involved-field radiotherapy (for patients with stage IA [nodal] disease): Patients undergo involved-field radiotherapy 5 days a week for 4 weeks.
- CLVPP chemotherapy (for patients with all other stages of disease AND no bulky mediastinal disease): Patients receive CLVPP chemotherapy comprising oral chlorambucil, oral procarbazine hydrochloride, and oral prednisolone on days 1-14 and vinblastine IV on days 1 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
- CLVPP chemotherapy and radiotherapy (for patients with all other stages of disease AND bulky mediastinal disease): Patients receive CLVPP chemotherapy as above. Patients then undergo radiotherapy to the mediastinum beginning 2 weeks after completing the last course of CLVPP chemotherapy.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 358 patients were accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||358 participants|
|Masking:||None (Open Label)|
|Official Title:||Hodgkins Disease Study|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417014
|Study Chair:||John Martin, MD||Royal Liverpool Children's Hospital, Alder Hey|
|OverallOfficial:||A. Barratt, MD||Royal Marsden NHS Foundation Trust|