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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
doxorubicin hydrochloride
vinblastine
standard subtotal nodal irradiation
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of California San Diego Cancer Center
  • CCOP - Christiana Care Health Services
  • Walter Reed Army Medical Center
  • CCOP - Mount Sinai Medical Center
  • University of Chicago Cancer Research Center
  • University of Iowa Hospitals and Clinics
  • University of Massachusetts Memorial Medical Center
  • University of Minnesota Cancer Center
  • Ellis Fischel Cancer Center - Columbia
  • Barnes-Jewish Hospital
  • CCOP - Southern Nevada Cancer Research Foundation
  • Norris Cotton Cancer Center
  • Roswell Park Cancer Institute
  • CCOP - North Shore University Hospital
  • Mount Sinai Medical Center, NY
  • State University of New York - Upstate Medical University
  • CCOP - Southeast Cancer Control Consortium
  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
  • Rhode Island Hospital
  • University of Tennessee, Memphis Cancer Center
  • Vermont Cancer Center
  • MBCCOP - Massey Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nodal RT

Chemotherapy + Nodal RT

Arm Description

subtotal nodal irradiation will consist of mantle and periaortic/spleen fields treated sequentially. Total dose 3600-4000 cGy over 20 fractions.

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.

Outcomes

Primary Outcome Measures

progression-free survival
overall survival

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 16, 2017
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Cancer and Leukemia Group B
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1. Study Identification

Unique Protocol Identification Number
NCT00002495
Brief Title
SWOG-9133 RT w/ or w/o Doxorubicin and Vinblastine in Stage I or Stage II Hodgkin's Disease
Official Title
Randomized Trial of Subtotal Nodal Irradiation Versus Doxorubicin, Vinblastine and Subtotal Nodal Irradiation for Stage I-IIA Hodgkin's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 1992 (undefined)
Primary Completion Date
November 2000 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Cancer and Leukemia Group B

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
348 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nodal RT
Arm Type
Experimental
Arm Description
subtotal nodal irradiation will consist of mantle and periaortic/spleen fields treated sequentially. Total dose 3600-4000 cGy over 20 fractions.
Arm Title
Chemotherapy + Nodal RT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Description
25 mg/m^2 on days 1 and 15
Intervention Type
Drug
Intervention Name(s)
vinblastine
Intervention Description
6 mg/m^2 on days 1 and 15
Intervention Type
Radiation
Intervention Name(s)
standard subtotal nodal irradiation
Intervention Description
3600-4000 cGy delivered over 20 fractions
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter
Title
overall survival
Time Frame
every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver W. Press, MD, PhD
Organizational Affiliation
University of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Todd H. Wasserman, MD
Organizational Affiliation
Washington University Siteman Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of California San Diego Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Ellis Fischel Cancer Center - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
CCOP - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Mount Sinai Medical Center, NY
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104-4241
Country
United States
Facility Name
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
University of Tennessee, Memphis Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Vermont Cancer Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-3498
Country
United States
Facility Name
MBCCOP - Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
PubMed Identifier
12972528
Citation
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 Clin Oncol. 2003 Sep 15;21(18):3512-9. doi: 10.1200/JCO.2003.01.044. Erratum In: J Clin Oncol. 2013 Jun 10;31(17):2231-2.
Results Reference
result
PubMed Identifier
11709567
Citation
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 stage IA to IIA Hodgkin's disease. J Clin Oncol. 2001 Nov 15;19(22):4238-44. doi: 10.1200/JCO.2001.19.22.4238.
Results Reference
result
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-2471, 575a, 2000.
Results Reference
result

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

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