SWOG-9133 RT w/ or w/o Doxorubicin and Vinblastine in Stage I or Stage II Hodgkin's Disease
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without doxorubicin and vinblastine in treating patients with stage I or stage II Hodgkin's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: doxorubicin hydrochloride Drug: vinblastine Radiation: standard subtotal nodal irradiation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Trial of Subtotal Nodal Irradiation Versus Doxorubicin, Vinblastine and Subtotal Nodal Irradiation for Stage I-IIA Hodgkin's Disease |
- progression-free survival [ Time Frame: every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter ] [ Designated as safety issue: No ]
| Enrollment: | 348 |
| Study Start Date: | September 1992 |
| Estimated Study Completion Date: | May 2015 |
| Primary Completion Date: | November 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nodal RT
subtotal nodal irradiation will consist of mantle and periaortic/spleen fields treated sequentially. Total dose 3600-4000 cGy over 20 fractions.
|
Radiation: standard subtotal nodal irradiation
3600-4000 cGy delivered over 20 fractions
|
|
Experimental: Chemotherapy + Nodal RT
3 cycles (28 days each) of chemotherapy (doxorubicin 25 mg/m^2 on days 1 and 15, vinblastine 6 mg/m^2 on days 1 and 15). Four weeks after last cycle, subtotal nodal irradiation (total dose 3600-4000 cGy over 20 fractions) will be given as described for the Nodal RT arm.
|
Drug: doxorubicin hydrochloride
25 mg/m^2 on days 1 and 15
Drug: vinblastine
6 mg/m^2 on days 1 and 15
Radiation: standard subtotal nodal irradiation
3600-4000 cGy delivered over 20 fractions
|
Detailed Description:
OBJECTIVES: I. Compare progression-free and overall survival of patients with clinical Stage IA/IIA Hodgkin's disease who have not undergone laparotomy and who are randomized to treatment with subtotal nodal irradiation with vs. without 3 courses of doxorubicin/vinblastine. II. Compare the long-term toxicities associated with these treatments, including cardiopulmonary toxicity, secondary malignancies, and infertility. III. Identify subgroups of patients (based on age, gender, tumor histology, number of disease sites, and presence of high neck presentation) that are particularly responsive to these treatments.
OUTLINE: Randomized study. Arm I: Radiotherapy. Subtotal nodal irradiation using megavoltage equipment (4-10 MeV). Arm II: 2-Drug Combination Chemotherapy followed by Radiotherapy. Doxorubicin, DOX, NSC-123127; Vinblastine, VBL, NSC-49842; followed by subtotal nodal irradiation as in Arm I.
PROJECTED ACCRUAL: 210 patients/arm will be enrolled over about 7 years.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Biopsy-proven Hodgkin's disease, subclassified according to the Rye system Clinical Stages IA, IEA, IIA, and IIEA according to modified Ann Arbor system Staging laparotomy not allowed Completely resected disease allowed Residual disease, if present, must be bidimensionally measurable No mediastinal mass greater than 1/3 the maximum chest diameter No infradiaphragmatic presentation No pericardial E lesions (small pericardial effusions in the absence of nodular pericardial disease allowed) Concurrent registration on protocol SWOG-9208 (quality-of-life study) required unless patient does not understand or read English
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: SWOG 0-2 Hematopoietic: AGC at least 2,000 Platelets within normal limits Hepatic: Bilirubin within normal limits Renal: Creatinine within normal limits Cardiovascular: LVEF normal No serious EKG abnormality Pulmonary: No serious pulmonary condition Other: No serious medical condition other than Hodgkin's disease No known AIDS or HIV-associated complex No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Adequately treated in situ carcinoma of the cervix No pregnant or lactating women Adequate contraception required of fertile patients Blood/body fluid analyses to determine eligibility completed within 14 days prior to registration; imaging studies for tumor measurement completed within 28 days prior to registration; screening exams other than blood/body fluid analyses, and imaging studies of nonmeasurable disease or uninvolved organs completed within 42 days prior to registration
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy for any reason Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for any reason Surgery: No staging laparotomy
Contacts and Locations
Show 22 Study Locations| Study Chair: | Oliver W. Press, MD, PhD | University of Washington |
| Study Chair: | Todd H. Wasserman, MD | Washington University Siteman Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00002495 History of Changes |
| Other Study ID Numbers: | CDR0000077691, U10CA032102, SWOG-9133, CLB-9391 |
| Study First Received: | November 1, 1999 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Doxorubicin Vinblastine |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013