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Study 13 of 344 for search of: | Canada, New Brunswick |
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Sponsors and Collaborators: |
National Cancer Institute of Canada Eastern Cooperative Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002561 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, with or without chemotherapy, with chemotherapy alone in treating patients with stage I or stage IIA Hodgkin's disease.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: ABVD regimen Drug: bleomycin Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: vinblastine Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A PHASE III STUDY OF RADIOTHERAPY OR ABVD PLUS RADIOTHERAPY VERSUS ABVD ALONE IN THE TREATMENT OF EARLY STAGE HODGKIN'S DISEASE |
Estimated Enrollment: | 450 |
Study Start Date: | January 1994 |
OBJECTIVES: I. Compare the 12-year survival of patients with clinical stage I-IIA Hodgkin's disease treated with radiotherapy with or without doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) versus ABVD only. II. Compare the freedom from progression at 5 and 10 years in patients treated with these regimens. III. Compare the complete remission rate, freedom from secondary disease progression at 5 and 10 years, and cause-specific survival at 5, 10, and 15 years in patients treated with these regimens. IV. Compare the short- and long-term toxicity of these regimens in these patients. V. Compare the quality of life of patients in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients who are under age 40 and have lymphocyte-predominant or nodular sclerosing histology, an erythrocyte sedimentation rate less than 50, and fewer than 4 disease sites (supradiaphragmatic or pelvic node sites) are assigned to cohort 1 (good prognosis). All other patients are assigned to cohort 2 (poor prognosis). Cohort 1: Arm I: Patients with supradiaphragmatic disease undergo radiotherapy to the supradiaphragmatic lymph node areas (mantle region), spleen, and para-aortic lymph nodes 5 days a week for 4 weeks. Patients with pelvic disease undergo radiotherapy to an "inverted-Y" field (excluding the spleen) 5 days a week for 4 weeks. Arm II: Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine IV on days 1 and 15 (ABVD). Treatment continues every 4 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete remission (CR) after course 2 receive 2 additional courses past CR. Patients with partial remission (PR) after course 2 receive 4 additional courses past PR. Patients with unconfirmed/uncertain complete remission (CRu) receive 2-4 additional courses past CRu. Cohort 2: Arm III: Patients receive ABVD as in arm II, followed 4-6 weeks later by concurrent radiotherapy to the mantle region and upper abdomen to the level of L2 5 days a week for 4 weeks. Alternatively, radiotherapy may also be administered sequentially to the mantle region 5 days a week for 4 weeks and then to the upper abdomen to the level of L2 5 days a week for 4 weeks. Arm IV: Patients receive ABVD only as in arm II. Patients with disease progression after treatment in arms II or IV are considered for radiotherapy. Quality of life is assessed on day 1 of each course of chemotherapy (arms II-IV) and on day 28 of the last course of chemotherapy (arms II and IV); on the first and final days of radiotherapy (arms I and III); at 4 weeks and at 3, 6, and 12 months after completion of radiotherapy (arms I and III) or chemotherapy (arms II and IV); and then annually for 2-10 years. Patients are followed at months 3, 6, and 12 and then annually thereafter.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 7.5 years.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven stage I-IIA Hodgkin's disease Needle core biopsy is sufficient for diagnosis Needle aspirate not sufficient for diagnosis Any histology allowed Up to 1 extranodal site allowed if encompassable in a standard radiotherapy field No extranodal disease that cannot be included in such a field (e.g., lung, bone) No B symptoms Iliofemoral, inguinal, or parailiac nodal involvement allowed No other intra-abdominal disease Complete excision at biopsy allowed Considered eligible for radiotherapy by radiation and medical oncologists No stage IA disease that might be treated with involved-field radiotherapy only and meets the following criteria: Lymphocyte-predominant or nodular sclerosing histology Disease bulk less than 3 cm Erythrocyte sedimentation rate less than 50 Unilateral high-neck only disease, defined by 1 of the following conditions: Disease located above the upper border of the thyroid cartilage Isolated epitrochlear adenopathy No bulky adenopathy, defined by 1 of the following criteria: Palpable nodal mass greater than 10 cm in diameter Mediastinal mass with a maximum diameter of at least one-third the maximum chest wall diameter If supradiaphragmatic disease present: No clinical splenic involvement, defined by 1 of the following criteria: Spleen palpable on physical exam and enlarged on imaging studies Spleen showing focal abnormalities on imaging study consistent with Hodgkin's disease No lytic or blastic lesions on plain radiograph or abnormalities on bone scan consistent with Hodgkin's disease No pleural effusions or ascites Pleural thickening or "blunting" of costophrenic angle only on x-ray may be allowed
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 125,000/mm3 Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) (unless elevation due to hemolytic anemia) Renal: Creatinine no greater than 2 times ULN Cardiovascular: No symptomatic congestive heart failure or coronary artery disease No known valvular disease (other than asymptomatic mitral valve prolapse) No congenital heart disease (other than asymptomatic atrial septal defects) Hypertension controlled with drug therapy allowed Pulmonary: FVC, FEV1, and DLCO at least 60% predicted for patients with symptomatic lung disease or asthma controlled by medication Other: HIV negative No clinical diagnosis of AIDS No other major medical illness that would preclude study therapy No other prior or concurrent malignancy (including carcinoma in situ of the cervix) except adequately treated basal cell skin cancer Not pregnant Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent growth factors during the first course of chemotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy Surgery: See Disease Characteristics No prior staging laparotomy Other: No other concurrent anticancer therapy No concurrent cardiac medications
Study Chair: | Ralph M. Meyer, MD, FRCPC | Margaret and Charles Juravinski Cancer Centre |
Study Chair: | Jane N. Winter, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000063481, CAN-NCIC-HD6, E-JHD06, NCI-V94-0427 |
Study First Received: | November 1, 1999 |
Last Updated: | January 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00002561 |
Health Authority: | United States: Federal Government |
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma adult lymphocyte predominant Hodgkin lymphoma |
adult lymphocyte depletion Hodgkin lymphoma adult nodular sclerosis Hodgkin lymphoma adult mixed cellularity Hodgkin lymphoma |
Lymphatic Diseases Dacarbazine Hodgkin's disease Immunoproliferative Disorders Hodgkin lymphoma, adult Vinblastine |
Sclerosis Lymphoproliferative Disorders Bleomycin Hodgkin Disease Lymphoma Doxorubicin |
Neoplasms by Histologic Type Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Antimitotic Agents Antibiotics, Antineoplastic |
Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Alkylating Alkylating Agents Antineoplastic Agents, Phytogenic |