NCT03935256
Adjuvant Sequential & Concurrent CarboTaxol + Radiotherapy for High Risk Endometrial Cancer
PHASE2
ACTIVE_NOT_RECRUITING
NCT03935256
INTERVENTIONAL
Phase II Study of Concurrent and Sequential Carboplatin and Paclitaxel With Adjuvant Radiotherapy for High Risk Endometrial Cancer
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.
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.
Endometrial Cancer
- TREATMENT
-
- Type: DRUG
- Name: Carboplatin and Paclitaxel
- Description: Regimen I: Carboplatin AUC 6 \& Paclitaxel 175mg/m2 given intravenously for 4 cycles during weeks 1, 10, 13, 16 Regimen II: Carboplatin AUC 2 \& Paclitaxel 45mg/m2 given intravenously for 2 cycles during weeks 4 \& 7 concurrent with radiotherapy
- Arm Group Labels: Full Dose Chemo, Reduced Dose Chemo + RT, Full Dose Chemo
-
- Type: RADIATION
- Name: Radiation Therapy
- Description: An external beam radiation dose of 45 Gy in 25 fractions is routinely prescribed to the Planning Target Volume (PTV) for postoperative radiotherapy. The Vaginal Brachytherapy (VBT) Boost will be delivered after the external beam radiation. Doses of 12-18 Gy in 2-3 fractions are often prescribed to the surface of the vagina to a treatment length of 3-5 cm. There is no standard dose or fractionation schedule, so this dose, fractionation, location of dose specification , and length of vagina treated will be individualized for the patient and will be at the discretion of the treating radiation oncologist.
- Arm Group Labels: Full Dose Chemo, Reduced Dose Chemo + RT, Full Dose Chemo
- Loyola University