Phase 2
Completed N=23
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer
Endometrial Cancer · Papillary Serous
Source: ClinicalTrials.gov NCT00542490 ↗
Enrolled (actual)
23
Serious AEs
4.4%
Results posted
Sep 2017
Primary outcomePrimary: Number of Patients With Progression-free Survival at 2 Years — 19 Participants
Summary
The purpose of this study is to determine the progression-free survival of patients with surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with high-intermediate risk factors treated by vaginal cuff brachytherapy followed by chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Progression-free Survival at 2 Years |
19 | — |
| SECONDARY Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy |
23 | — |
Eligibility Criteria
Inclusion Criteria
- All patients must have undergone specified complete surgical staging.
- Patients must be surgically staged endometrial cancer patients at high-risk for recurrence.
- Patients must have adequate bone marrow, renal and hepatic function.
Exclusion Criteria
- Patients with recurrent disease.
- Patients with GOG performance status of 3 or 4.
Data sourced from ClinicalTrials.gov (NCT00542490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.