Adjuvant Sequential & Concurrent CarboTaxol + Radiotherapy for High Risk Endometrial Cancer
Status:
Recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
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.