SWOG-9133 RT w/ or w/o Doxorubicin and Vinblastine in Stage I or Stage II Hodgkin's Disease

Lymphoma Clinical Trial

Official title:

Randomized Trial of Subtotal Nodal Irradiation Versus Doxorubicin, Vinblastine and Subtotal Nodal Irradiation for Stage I-IIA Hodgkin's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002495
• Other study ID #: CDR0000077691
• Secondary ID: U10CA032102SWOG-
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: February 16, 2017
• Start date: September 1992
• Est. completion date: April 2014

Study information

• Verified date: February 2017
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: April 2014
• Est. primary completion date: November 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Drug:
• doxorubicin hydrochloride
25 mg/m^2 on days 1 and 15
• vinblastine
6 mg/m^2 on days 1 and 15

Radiation:
• standard subtotal nodal irradiation
3600-4000 cGy delivered over 20 fractions

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Vermont Cancer Center	Burlington	Vermont
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of California San Diego Cancer Center	La Jolla	California
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	University of Tennessee, Memphis Cancer Center	Memphis	Tennessee
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Mount Sinai Medical Center, NY	New York	New York
United States	Rhode Island Hospital	Providence	Rhode Island
United States	MBCCOP - Massey Cancer Center	Richmond	Virginia
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	State University of New York - Upstate Medical University	Syracuse	New York
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	CCOP - Christiana Care Health Services	Wilmington	Delaware
United States	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina
United States	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Southwest Oncology Group	Cancer and Leukemia Group B, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Ganz PA, Moinpour CM, McCoy S, et al.: Predictors of vitality (energy/fatigue) in early stage Hodgkin's disease (HD): results from Southwest Oncology Group (SWOG) study 9133. [Abstract] J Clin Oncol 22 (Suppl 14): A-6546, 569s, 2004.

Ganz PA, Moinpour CM, Pauler DK, Kornblith AB, Gaynor ER, Balcerzak SP, Gatti GS, Erba HP, McCoy S, Press OW, Fisher RI. Health status and quality of life in patients with early-stage Hodgkin's disease treated on Southwest Oncology Group Study 9133. J Cli — View Citation

Press OW, LeBlanc M, Lichter A, et al.: A phase III randomized intergroup trial of subtotal lymphoid irradiation (STLI) versus doxorubicin, vinblastine, and STLI for stage IA-IIA Hodgkin's disease (SWOG 9133, CALGB 9391). [Abstract] Blood 96(11 pt 1), A-2

Press OW, LeBlanc M, Lichter AS, Grogan TM, Unger JM, Wasserman TH, Gaynor ER, Peterson BA, Miller TP, Fisher RI. Phase III randomized intergroup trial of subtotal lymphoid irradiation versus doxorubicin, vinblastine, and subtotal lymphoid irradiation for — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter
Primary	overall survival		every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter