Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery
Summary
This randomized phase III trial studies radiation therapy with chemotherapy to see how well they work compared to radiation therapy alone in treating patients with stage I-IIA cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.
Timeline
- Start
- 2010-04-12
- Primary completion
- 2024-01-15
- Completion
- 2024-04-02
Outcome
Missed primary endpoint
registry analysis (superiority test); Arm I (Radiation) vs Arm II (Cisplatin + Radiation); p = 0.0927; NCT01101451 ↗
paper Although RFS and OS favored CRT, the addition of cisplatin during RT did not statistically improve RFS or OS in cervical cancer patients PMID 40947016 ↗
Publications
- Ryu SY, Deng W, Albuquerque K, Koh WJ, Mayadev J, Heugel A, Kim BJ, Kim DY, Cho CH, Kim JW, No JH, Mannel RS, Miller K, Fabian D, Chase DM, Gil KM, Small W Jr, Rodgers W, Leath CA 3rd, Monk BJ. Randomized phase III trial of adjuvant radiation versus chemoradiation in intermediate-risk, early-stage cervical cancer following radical hysterectomy and lymphadenectomy: results from NRG Oncology/GOG-263/KGOG 1008. Ann Oncol. 2025 Dec;36(12):1514-1524. doi: 10.1016/j.annonc.2025.09.003. Epub 2025 Sep 12.
- Kim H, Park W, Kim YS, Kim YJ. Chemoradiotherapy is not superior to radiotherapy alone after radical surgery for cervical cancer patients with intermediate-risk factor. J Gynecol Oncol. 2020 May;31(3):e35. doi: 10.3802/jgo.2020.31.e35. Epub 2019 Nov 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 40 mg/m2 | Intravenous |