Clinical trial · Interventional
Adjuvant Sequential & Concurrent CarboTaxol + Radiotherapy for High Risk Endometrial Cancer
Phase II Study of Concurrent and Sequential Carboplatin and Paclitaxel With Adjuvant Radiotherapy for High Risk Endometrial Cancer
- 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)
The purpose of this trial is to evaluate the safety of sequential and concurrent carboplatin and paclitaxel with adjuvant external beam radiotherapy for locally advanced endometrial cancer. The primary objective is to assess the acute toxicities namely grade 3-4 non hematologic and grade 4 hematologic toxicities associated with the above regimen. The null hypothesis is that the unacceptable toxic response rate is ≥40%. This will be tested against a one-sided alternative that the toxicity rate is 20% or less. Simon's two-stage design was used to power this aim. In the first stage, 11 patients will be accrued. If there are 5 or more toxic responses in these 11 patients, the study will be stopped for safety reasons. Otherwise, 13 additional patients will be accrued for a total of 24 patients. Under these conditions, the probability of stopping early is 47% if the toxic response rate is truly higher than 20.0%. If this regimen is safe then its efficacy can be studied in a Phase III study.
Conditions
Conditions (1)
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 Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin and Paclitaxel | Drug | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Full Dose Chemo, Reduced Dose Chemo + RT, Full Dose Chemo
- description
- Week 1 : Cycle 1: Full Dose Carboplatin and Paclitaxel Week 4: Pelvic Radiotherapy Begins Cycle 2: Dose reduced Carboplatin and Paclitaxel Week 7 : Cycle 3: Dose reduced Carboplatin and Paclitaxel Weeks 10,13,16: Cycle 4-6: Full Dose Carboplatin and Paclitaxel
- interventionNames
- Drug: Carboplatin and Paclitaxel
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Acute Toxicities (CTCAE v5.0)
- timeFrame
- 24 weeks
- description
- The primary outcome will be the number of Grade 3-4 acute non-hematologic and grade 4 hematologic toxicities associated with sequential and concurrent carboplatin and paclitaxel with EBRT in the adjuvant management of endometrial cancer patients as described in CTCAE version 5.0. These toxicities will be assess during the on treatment visits by the radiation and medical oncologist. If there are 5 or more toxic responses in the first 11 patients the study will be stopped for safety reasons.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Surgically managed endometrial cancer with total or radical hysterectomy with pathology of endometrioid, serous, clear cell or carcinosarcoma histologies
* Any patient for whom combination of adjuvant radiotherapy and chemotherapy is recommended following pathology review
* Endometrioid type FIGO Stage I-II with high risk features AND IIIC1, IVA
* Serous Carcinoma, Clear Cell Carcinoma, Carcinosarcoma Stage I-IIIC1, IVA
* ECOG Performance Status 0-2
* No prior history of pelvic radiotherapy
* No clinical or radiographic evidence of nodal disease or distant metastases
* Ability to understand and willingness to sign a written informed consent.
Exclusion Criteria:
* Patients undergoing irradiation of the para-aortic node chain
* Prior history of endometrial cancer
* Prior local radiotherapy for a pelvic malignancy
* Prior platinum or taxane based chemotherapy for any malignancy
* Patients receiving any other investigational agents
* Patients with a known malignancy with a disease free interval \< 6 months prior to enrollment
* Uncontrolled intercurrent illness including but not limited to ongoing or active infection, severely symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that could limit compliance with study requirements
* Patients enrolled on a competing investigational study.References
Publications (27)
- BACKGROUNDBachaud JM, Fu RC, Delannes M, Izar F, Martel P, David JM, Shubinski RE, Daly NJ, Montana GS. Non-randomized comparative study of irradiation alone or in combination with surgery in stage Ib, IIa and "proximal" IIb carcinoma of the cervix. Radiother Oncol. 1991 Oct;22(2):104-10. doi: 10.1016/0167-8140(91)90005-2. PMID 1957000
- BACKGROUNDConklin CM, Longacre TA. Endometrial stromal tumors: the new WHO classification. Adv Anat Pathol. 2014 Nov;21(6):383-93. doi: 10.1097/PAP.0000000000000046. PMID 25299308
- BACKGROUNDde Boer SM, Powell ME, Mileshkin L, Katsaros D, Bessette P, Haie-Meder C, Ottevanger PB, Ledermann JA, Khaw P, Colombo A, Fyles A, Baron MH, Kitchener HC, Nijman HW, Kruitwagen RF, Nout RA, Verhoeven-Adema KW, Smit VT, Putter H, Creutzberg CL; PORTEC study group. Toxicity and quality of life after adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1114-1126. doi: 10.1016/S1470-2045(16)30120-6. Epub 2016 Jul 7. PMID 27397040
- BACKGROUNDAalders J, Abeler V, Kolstad P, Onsrud M. Postoperative external irradiation and prognostic parameters in stage I endometrial carcinoma: clinical and histopathologic study of 540 patients. Obstet Gynecol. 1980 Oct;56(4):419-27. PMID 6999399
- BACKGROUNDCreasman WT, Morrow CP, Bundy BN, Homesley HD, Graham JE, Heller PB. Surgical pathologic spread patterns of endometrial cancer. A Gynecologic Oncology Group Study. Cancer. 1987 Oct 15;60(8 Suppl):2035-41. doi: 10.1002/1097-0142(19901015)60:8+3.0.co;2-8. PMID 3652025
- BACKGROUNDCreutzberg CL, van Putten WL, Koper PC, Lybeert ML, Jobsen JJ, Warlam-Rodenhuis CC, De Winter KA, Lutgens LC, van den Bergh AC, van de Steen-Banasik E, Beerman H, van Lent M. Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma: multicentre randomised trial. PORTEC Study Group. Post Operative Radiation Therapy in Endometrial Carcinoma. Lancet. 2000 Apr 22;355(9213):1404-11. doi: 10.1016/s0140-6736(00)02139-5.