Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Eastern Cooperative Oncology Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Southwest Oncology Group
NCIC Clinical Trials Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00003389
First received: November 1, 1999
Last updated: April 2, 2013
Last verified: July 2006
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Biological: bleomycin sulfate
Drug: ABVD regimen
Drug: Stanford V regimen
Drug: cyclophosphamide
Drug: dacarbazine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: mechlorethamine hydrochloride
Drug: prednisone
Drug: vinblastine
Drug: vincristine sulfate
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of ABVD Versus Stanford V(+/-) Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease Without High Risk Features

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Failure-free survival as measured by two-sided 0.05 level logrank test at completion of therapy and then every 6 months for 3 years [ Designated as safety issue: No ]
  • Overall progression-free survival by two-sided 0.05 level logrank test 5 and 10 years following study completion [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary function by forced vital capacity and DLCO at baseline and 5 years following study completion [ Designated as safety issue: No ]
  • Second cancers [ Designated as safety issue: No ]
  • Reproductive function by Reproductive Health Assessment questionnaire, semen analysis, follicle-stimulating hormone, and luteinizing hormone at baseline and 5 years following study completion [ Designated as safety issue: No ]
  • Deaths from causes other than Hodgkin's disease [ Designated as safety issue: No ]
  • Corr. new EBV detect. tech. in plasma and tumor tissue w/ cytotoxic T-cell response to EBV antigens and antigens from other viruses before study tx, at 1 wk, at 1 mo. after compl. of tx, & 1 year from study entry [ Designated as safety issue: Yes ]
  • Corr. new EBV detect. tech. in plasma and tumor tiss. w/ impact of chemotherapy and/or radiotherapy on T-cell responses to EBV ags and ags from other viruses before study tx, at 1 wk, at 1 mo. after compl. of tx, & 1 year from study entry [ Designated as safety issue: No ]

Estimated Enrollment: 850
Study Start Date: November 2000
Detailed Description:

OBJECTIVES:

  • Compare the failure-free survival of patients with locally extensive or advanced Hodgkin's lymphoma treated with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) vs doxorubicin, vinblastine, vincristine, bleomycin, mechlorethamine, etoposide, and prednisone (Stanford V) with or without radiotherapy.
  • Compare the overall survival and freedom from progression in these patients at 5 and 10 years after treatment with these regimens.
  • Compare pulmonary function, incidence of second cancers, reproductive function, and deaths from causes other than Hodgkin's lymphoma in patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to number of adverse risk factors (0-2 vs 3-7) and disease characteristics (locally extensive vs advanced). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine IV on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
  • Arm II: Patients receive Stanford V chemotherapy comprising doxorubicin and vinblastine IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine and bleomycin IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide IV); etoposide IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.

Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 850 patients will be accrued for this study within 4.3 years.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven previously untreated classical Hodgkin's lymphoma of the following subtypes:

    • Nodular sclerosis
    • Mixed cellularity
    • Lymphocyte depletion
    • Lymphocyte rich
  • The following stages are eligible:

    • Stage I-IIA/B with massive mediastinal adenopathy
    • Stage III or IV
  • Measurable or evaluable disease

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 4,000/mm^3 (unless documented bone marrow involvement)
  • Platelet count at least 100,000/mm^3 (unless documented bone marrow involvement)

Hepatic:

  • Bilirubin no greater than 5.0 mg/dL

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • Ejection fraction determination recommended if over age 50 and/or have a history of cardiac disease

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Prior corticosteroids allowed

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Prior surgery allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003389

  Show 539 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Southwest Oncology Group
NCIC Clinical Trials Group
Cancer and Leukemia Group B
Investigators
Study Chair: Sandra J. Horning, MD Stanford University
Study Chair: Richard I. Fisher, MD James P. Wilmot Cancer Center
Study Chair: Joseph M. Connors, MD British Columbia Cancer Agency
Study Chair: Nancy L. Bartlett, MD Washington University Siteman Cancer Center
  More Information

Additional Information:
No publications provided by Eastern Cooperative Oncology Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00003389     History of Changes
Other Study ID Numbers: CDR0000066386, ECOG-2496, CAN-NCIC-HD7, CALGB-59905, SWOG-E2496
Study First Received: November 1, 1999
Last Updated: April 2, 2013
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
adult lymphocyte depletion Hodgkin lymphoma
adult nodular sclerosis Hodgkin lymphoma
adult mixed cellularity Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Mechlorethamine
Cyclophosphamide
Dacarbazine
Etoposide
Prednisone
Vinblastine
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 20, 2014