Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer
Summary
This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with cervical cancer has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of \[cancer/tumor\] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kills more tumor cells.
Timeline
- Start
- 2012-01-09
- Primary completion
- 2021-07-09
- Completion
- 2021-07-09
Outcome
Missed primary endpoint
paper p=0·81 PMID 37080223 ↗
paper Adjuvant carboplatin and paclitaxel chemotherapy given after standard cisplatin-based chemoradiotherapy for unselected locally advanced cervical cancer increased short-term toxicity and did not improve overall survival PMID 37080223 ↗
Publications
- Mileshkin LR, Moore KN, Barnes EH, Gebski V, Narayan K, King MT, Bradshaw N, Lee YC, Diamante K, Fyles AW, Small W Jr, Gaffney DK, Khaw P, Brooks S, Thompson JS, Huh WK, Mathews CA, Buck M, Suder A, Lad TE, Barani IJ, Holschneider CH, Van Dyk S, Quinn M, Rischin D, Monk BJ, Stockler MR. Adjuvant chemotherapy following chemoradiotherapy as primary treatment for locally advanced cervical cancer versus chemoradiotherapy alone (OUTBACK): an international, open-label, randomised, phase 3 trial. Lancet Oncol. 2023 May;24(5):468-482. doi: 10.1016/S1470-2045(23)00147-X. Epub 2023 Apr 17.
- Gould HJ 3rd, Miller PR, Edenfield S, Sherman KJ, Brady CK, Paul D. Emergency Use of Targeted Osmotic Lysis for the Treatment of a Patient with Aggressive Late-Stage Squamous Cell Carcinoma of the Cervix. Curr Oncol. 2021 Jun 8;28(3):2115-2122. doi: 10.3390/curroncol28030196.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Subject | Paclitaxel | Small molecule | 155 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 40 mg/m2 | Intravenous |