drugset / Trial / NCT00002495
SWOG-9133 RT w/ or w/o Doxorubicin and Vinblastine in Stage I or Stage II Hodgkin's Disease
Phase 3
Completed
348 enrolled
SWOG Cancer Research Network
Cancer and Leukemia Group B · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 1992-09
- Primary completion
- 2000-11
- Completion
- 2014-04
Outcome
Met primary endpoint
paper markedly superior failure-free survival (FFS) rate for patients on the CMT arm (94%) compared with the STLI arm (81%). PMID 11709567 ↗
paper 10 patients have experienced relapse or died on the chemoradiotherapy arm, compared with 34 on the radiotherapy arm (P <.001). PMID 11709567 ↗
Publications
- Results 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 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.
- Results 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 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 25 mg/m2 | — |
| Subject | Vinblastine | Small molecule | 6 mg/m2 | — |