Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients who have advanced Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have advanced Hodgkin's lymphoma.

Detailed Description
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OBJECTIVES: Compare relapse-free and overall survival of patients with previously untreated advanced Hodgkin's lymphoma treated with bleomycin, doxorubicin, etoposide, mechlorethamine, vinblastine, vincristine, and prednisone (Stanford V) vs doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I (Stanford V): Patients receive mechlorethamine on weeks 1, 5, and 9; vinblastine and doxorubicin on weeks 1, 3, 5, 7, 9, and 11; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and vincristine and bleomycin on weeks 2, 4, 6, 8, 10, and 12. Patients also receive oral prednisone every other day on days 1-63 followed by a taper on days 64-84. Treatment continues for 12 weeks. Arm II (ABVD): Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine on days 1 and 15. Treatment repeats every 28 days for 6-8 courses. All patients achieving a complete remission or partial remission after chemotherapy undergo involved field radiotherapy if they had initial bulky mediastinal disease, initial nodal masses at least 5 cm in diameter, or initial splenic disease. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: Approximately 700-850 patients will be accrued for this study.

Official Title
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Protocol for a Randomized Phase III Study of the Stanford V Regimen, Compared With ABVD for the Treatment of Advanced Hodgkin's Disease

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: bleomycin sulfate
* Drug: ABVD regimen
* Drug: Stanford V regimen
* Drug: dacarbazine
* Drug: doxorubicin hydrochloride
* Drug: etoposide
* Drug: mechlorethamine hydrochloride
* Drug: prednisone
* Drug: vinblastine sulfate
* Drug: vincristine sulfate
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed Hodgkin's lymphoma (any sub-type) Stage IB, IIB, IIIA, IIIB, or IV OR Stage IA or IIA with locally extensive disease (e.g., bulky mediastinal disease (e.g., greater than 0.33 of the maximum transthoracic diameter on routine chest X-ray or at least 2 extranodal sites of disease)) PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Complete blood count normal unless directly due to Hodgkin's lymphoma Hepatic: Hepatic function normal unless directly due to Hodgkin's lymphoma Renal: Renal function normal unless directly due to Hodgkin's lymphoma Cardiovascular: No pre-existing cardiac disease Pulmonary: No pre-existing pulmonary disease Other: Not pregnant Fertile patients must use effective contraception during and for six months after study HIV negative No other prior malignancy except basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior therapy for Hodgkin's lymphoma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: bleomycin sulfate|nan|
|Drug: ABVD regimen|nan|
|Drug: Stanford V regimen|nan|
|Drug: dacarbazine|nan|
|Drug: doxorubicin hydrochloride|nan|
|Drug: etoposide|nan|
|Drug: mechlorethamine hydrochloride|nan|
|Drug: prednisone|nan|
|Drug: vinblastine sulfate|nan|
|Drug: vincristine sulfate|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, adult lymphocyte predominant Hodgkin lymphoma, adult lymphocyte depletion Hodgkin lymphoma, adult nodular sclerosis Hodgkin lymphoma, adult mixed cellularity Hodgkin lymphoma