Adjuvant Sequential & Concurrent CarboTaxol + Radiotherapy for High Risk Endometrial Cancer

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

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.