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

Sponsor

Southwest Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00002495

Collaborator

National Cancer Institute (NCI) (NIH), Cancer and Leukemia Group B (Other)

348

Enrollment

Locations

Arms

259

Duration (Months)

15.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: doxorubicin hydrochloride Drug: vinblastine Radiation: standard subtotal nodal irradiation	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

348 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Sep 1, 1992

Actual Primary Completion Date :

Nov 1, 2000

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

progression-free survival [every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter]
overall survival [every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of California San Diego Cancer Center	La Jolla	California	United States	92093-0658
2	CCOP - Christiana Care Health Services	Wilmington	Delaware	United States	19899
3	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
4	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
5	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637
6	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
7	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01655
8	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
9	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri	United States	65203
10	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
11	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
12	Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756
13	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
14	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
15	Mount Sinai Medical Center, NY	New York	New York	United States	10029
16	State University of New York - Upstate Medical University	Syracuse	New York	United States	13210
17	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
18	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157-1082
19	Rhode Island Hospital	Providence	Rhode Island	United States	02903
20	University of Tennessee, Memphis Cancer Center	Memphis	Tennessee	United States	38163
21	Vermont Cancer Center	Burlington	Vermont	United States	05401-3498
22	MBCCOP - Massey Cancer Center	Richmond	Virginia	United States	23298-0037