At a glance
ClinicalIndex Comparison Record- ✓Stage III, IV, or recurrent endometrial carcinoma with poor prognosis for cure by radiation or surgery alone
- ✓Pathological confirmation and ER/PR status of primary tumor mandatory (results do not need to be available before registration)
- ✓No prior cytotoxic chemotherapy (chemotherapy for radiation sensitization also excluded)
- ✓Prior radiation, hormonal, or biologic therapy allowed if discontinued before study entry
- ✕Concomitant malignancy other than non-melanoma skin cancer; prior invasive malignancy within 5 years or with prior chemotherapy for that malignancy
- ✕Pathological confirmation or ER/PR status not obtainable
- ✕Planned radiation therapy during or after study chemotherapy prior to documented progression
- ✕Serious uncontrolled infection, uncontrolled angina, or serious peripheral neuropathy making treatment hazardous
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF Versus Carboplatin/Paclitaxel in Patients With Stage III &Amp; IV or Recurrent Endometrial Cancer
In Brief
A Phase 3 clinical trial evaluating Carboplatin, Cisplatin, and 6 other interventions for Recurrent Uterine Corpus Carcinoma and 5 related conditions. Completed, enrolled 1,381 participants across 650 sites in 3 countries.
Detailed Summary
This randomized phase III trial compares how well two different combination chemotherapy regimens (doxorubicin hydrochloride, cisplatin, and paclitaxel versus carboplatin and paclitaxel) work in treating patients with endometrial cancer that is stage III-IV or has come back (recurrent). Drugs used in chemotherapy such as doxorubicin hydrochloride, cisplatin, paclitaxel, and carboplatin, 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. It is not yet known which combination chemotherapy regimen is more effective in treating endometrial cancer.
Study Details
Timeline
Interventions
Given IV
Given IV
Given IV
Given SC
Correlative studies
Given IV
Given SC
Ancillary studies