This trial is active, not recruiting.

Condition lymphoma
Treatments bleomycin sulfate, abvd regimen, stanford v regimen, dacarbazine, doxorubicin hydrochloride, etoposide, mechlorethamine hydrochloride, prednisone, vinblastine sulfate, vincristine sulfate, radiation therapy
Phase phase 3
Sponsor Mount Vernon Cancer Centre at Mount Vernon Hospital
Start date October 2001
Trial size 850 participants
Trial identifier NCT00041210, BNLI-STANFORDV, CDR0000069453, EU-20206


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Relapse-free survival
time frame:

Secondary Outcomes

Overall survival
time frame:
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Protocol for a Randomized Phase III Study of the Stanford V Regimen, Compared With ABVD for the Treatment of Advanced Hodgkin's Disease
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).