RTOG 90-01
Pelvic radiation with concurrent fluorouracil and cisplatin versus pelvic and para-aortic radiation for high-risk cervical cancer (RTOG 90-01)
N = 403
- Population
- Women with advanced cervical cancer confined to the pelvis: stages IIB through IVA, or stage IB or IIA with a tumour diameter of at least 5 cm or involvement of pelvic lymph nodes
- Design
- Randomised comparison, 1990 to 1997: 45 Gy to the pelvis and para-aortic lymph nodes (extended-field radiotherapy), or 45 Gy to the pelvis alone plus two cycles of fluorouracil and cisplatin (days 1 to 5 and 22 to 26 of radiation); low-dose-rate intracavitary radiation followed in both groups, with a third chemotherapy cycle planned in the combined-therapy group. 403 women were eligible; 193 per group could be evaluated.
- Arms
- Pelvic and para-aortic radiotherapy (control, n = 193): 45 Gy to the pelvis and para-aortic lymph nodes, then intracavitary radiation
- Pelvic radiotherapy with fluorouracil and cisplatin (experimental, n = 193): 45 Gy to the pelvis plus fluorouracil and cisplatin (two cycles, third planned with intracavitary radiation), then intracavitary radiation
- People
- Morris M, senior author Mutch DG, Radiation Therapy Oncology Group
Δ 60-month OS+15 pointsΔ 60-month DFS+27 pointsΔ 96-month OS+26 points
Show the numbers
| Endpoint | Analysis | Pelvic radiotherapy with fluorouracil and cisplatin | Pelvic and para-aortic radiotherapy | Effect |
|---|---|---|---|---|
| OSEvaluable patients (193 per group, of 403 eligible) | primarymedian follow-up 43 monthsMorris 1999 | 73% at 5 y | 58% at 5 y | P=0.004Estimated cumulative rates of survival at five years. |
| DFSEvaluable patients (193 per group, of 403 eligible) | primarymedian follow-up 43 monthsMorris 1999 | 67% at 5 y | 40% at 5 y | P<0.001Cumulative rates of disease-free survival at five years. |
| OSWomen randomised in the trial (403); the abstract does not name the analysis population | long term-updatemedian follow-up 6.6 yearsEifel 2004 | 67% at 8 y | 41% at 8 y | P<.0001Median follow-up of 6.6 years was for the 228 surviving patients. The abstract also reports an overall reduction in the risk of disease recurrence of 51% (95% CI, 36% to 66%) with chemotherapy plus radiotherapy, and similar rates of serious late complications in the two arms. |
| Endpoint | Analysis | Pelvic radiotherapy with fluorouracil and cisplatin | Pelvic and para-aortic radiotherapy | Effect |
|---|---|---|---|---|
| OSEvaluable patients (193 per group, of 403 eligible) | primarymedian follow-up 43 monthsMorris 1999 | 73% at 5 y | 58% at 5 y | P=0.004Estimated cumulative rates of survival at five years. |
| DFSEvaluable patients (193 per group, of 403 eligible) | primarymedian follow-up 43 monthsMorris 1999 | 67% at 5 y | 40% at 5 y | P<0.001Cumulative rates of disease-free survival at five years. |
| OSWomen randomised in the trial (403); the abstract does not name the analysis population | long term-updatemedian follow-up 6.6 yearsEifel 2004 | 67% at 8 y | 41% at 8 y | P<.0001Median follow-up of 6.6 years was for the 228 surviving patients. The abstract also reports an overall reduction in the risk of disease recurrence of 51% (95% CI, 36% to 66%) with chemotherapy plus radiotherapy, and similar rates of serious late complications in the two arms. |
Appears in
Sources
Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, et al. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999;340(15):1137-43.
Eifel PJ, Winter K, Morris M, Levenback C, Grigsby PW, Cooper J, et al. Pelvic irradiation with concurrent chemotherapy versus pelvic and para-aortic irradiation for high-risk cervical cancer: an update of radiation therapy oncology group trial (RTOG) 90-01. J Clin Oncol. 2004;22(5):872-80.