Clinical trial · Interventional
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
A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Clear Cell Adenocarcinoma | Endometrial Clear Cell Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Serous Adenocarcinoma | Endometrial Serous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IA Uterine Corpus Cancer AJCC v7 | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Uterine Corpus Cancer AJCC v7 | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Uterine Corpus Cancer AJCC v7 | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Uterine Corpus Cancer AJCC v7 | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Internal Radiation Therapy | Radiation | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)
- description
- Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Carboplatin
- Drug: Cisplatin
- Radiation: Internal Radiation Therapy
- Drug: Paclitaxel
- Other: Quality-of-Life Assessment
- Radiation: Radiation Therapy
- type
- ACTIVE_COMPARATOR
- label
- Arm II (paclitaxel and carboplatin)
- description
- Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients with surgical stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria including clear cell and serous papillary and undifferentiated carcinoma * Surgical stage III disease includes those patients with positive adnexa, parametrial involvement, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement * Surgical stage IVA patients with bladder or bowel mucosal involvement, but no spread outside the pelvis * Patients with FIGO 2009 surgical stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology * Surgery must have included a hysterectomy and bilateral salpingo-oophorectomy; pelvic lymph node sampling and para-aortic lymph node sampling are optional * Patients with a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 * White blood cell (WBC) \>= 3,000/mcl * Absolute neutrophil count (ANC) \>= 1,500/mcl * Platelet count \>= 100,000/mcl * Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =\< 2.5 x upper limit of normal (ULN) * Alkaline phosphatase =\< 2.5 times ULN * Bilirubin =\< 1.5 times ULN * Creatinine =\< institutional ULN * Patients who have met the pre-entry requirements; testing values/results must meet eligibility criteria * Patients who have signed an approved informed consent and authorization permitting release of personal health information * Entry into the study is limited to no more than 8 weeks from the date of surgery Exclusion Criteria: * Patients with carcinosarcoma * Patients with recurrent endometrial cancer * Patients with residual tumor after surgery (any single site) exceeding 2 cm in maximum dimension * Patients who have had pelvic or abdominal radiation therapy * Patients with positive pelvic washings as the only extra-uterine disease are NOT eligible if the histology is other than clear cell or papillary serous carcinoma * Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy * Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy * Patients with an estimated survival of less than three months * Patients with FIGO 2009 stage IVB endometrial cancer * Patients with parenchymal liver metastases * Patients who have received prior chemotherapy for endometrial cancer * Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment
References
Publications (3)
- DERIVEDMatei 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. PMID 39700442
- DERIVEDMatulonis 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. PMID 34903380
- DERIVEDMatei 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. PMID 31189035