Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer

Summary

This randomized phase III trial studies carboplatin and paclitaxel to see how well they work with or without cisplatin and radiation therapy in treating patients with stage I-IVA endometrial cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether carboplatin and paclitaxel are more effective with or without cisplatin and radiation therapy in treating patients with endometrial cancer.

Timeline

Start

2009-06-29

Primary completion

2016-02-15

Completion

2024-07-28

Outcome

Missed primary endpoint

paper Chemotherapy plus radiation was not associated with longer relapse-free survival than chemotherapy alone in patients with stage III or IVA endometrial carcinoma. PMID 31189035 ↗

Publications

• Matei DE, Enserro DM, Randall ME, Mutch D, Small W, DiSilvestro PA, Spirtos NM, O'Malley DM, Cantuaria GH, Michelin D, Waggoner S, Shahin M, Guntupalli S, Lara O, Ueland FR, Warshal D, Bonebrake A, Tewari KS, Tan A, Powell MA, Walker JL, Santin AD, Kim JH, Miller DS. Long-Term Follow-Up and Overall Survival in NRG258, a Randomized Phase III Trial of Chemoradiation Versus Chemotherapy for Locally Advanced Endometrial Carcinoma. J Clin Oncol. 2025 Mar 20;43(9):1055-1060. doi: 10.1200/JCO.24.01121. Epub 2024 Dec 19.
• Matulonis UA, Huang HQ, Filiaci VL, Randall M, DiSilvestro PA, Moxley KM, Fowler JM, Powell MA, Spirtos NM, Tewari KS, Richards WE, Nakayama JM, Mutch DG, Miller DS, Matei D, Wenzel LB. Patient reported outcomes for cisplatin and radiation followed by carboplatin/paclitaxel versus carboplatin/paclitaxel for locally advanced endometrial carcinoma: An NRG oncology study. Gynecol Oncol. 2022 Feb;164(2):428-436. doi: 10.1016/j.ygyno.2021.11.021. Epub 2021 Dec 11.
• Matei D, Filiaci V, Randall ME, Mutch D, Steinhoff MM, DiSilvestro PA, Moxley KM, Kim YM, Powell MA, O'Malley DM, Spirtos NM, Small W Jr, Tewari KS, Richards WE, Nakayama J, Matulonis UA, Huang HQ, Miller DS. Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer. N Engl J Med. 2019 Jun 13;380(24):2317-2326. doi: 10.1056/NEJMoa1813181.

Drugs

Indications