Clinical trial · Interventional
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer
Phase II Trial of Vaginal Cuff Brachytherapy Followed by Adjuvant Chemotherapy With Carboplatin and Dose Dense Paclitaxel in Patients With High-Risk Endometrial Cancer
NCT03189446CI-TRIAL-00074860completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the feasibility of treatment in patients with high risk endometrial cancer treated by vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Endometrial Cancer | Endometrial Neoplasm | PROBABILISTIC | 0.70 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Papillary Serous | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Vaginal Cuff Brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vaginal Cuff Brachytherapy + Chemotherapy
- description
- Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles
- interventionNames
- Radiation: Vaginal Cuff Brachytherapy
- Drug: Carboplatin
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Number of Patients Completing the Protocol
- timeFrame
- 4 months
- description
- Defined as completion of vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy
Secondary outcomes (5)
- measure
- Frequency of Adverse Events Related to Acute Toxicity During Treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria:
1. All patients must have undergone hysterectomy. Bilateral salpingooophorectomy is strongly encouraged but not mandatory.
2. Pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged. Peritoneal washing are optional.
3. If either a bilateral salpingo-oophorectomy or nodal dissection was not performed, post-operative pre-treatment CT/MRI is required and must not demonstrate evidence suggestive of metastatic disease (adnexa, nodes, intraperitoneal disease). Post-operative, pre-treatment CT/MRI must be performed if a pelvic and para-aortic nodal dissection was not performed.
4. All patients will be staged according to the FIGO 2009 staging system and with endometrial carcinoma (endometrioid types) confined to the corpus uteri or with endocervical glandular involvement fitting one of the following high-intermediate risk factor categories:
* age ≥18 years with 3 risk factors
* Risk factors:
1. Grade 2 or 3 tumor, (+) lymphovascular space invasion, outer ½ myometrial invasion. Patients with these risk criteria may be enrolled with either positive or negative cytology.
2. Patients with Stage II endometrial carcinoma (any histology) with cervical stromal invasion. (occult or gross involvement), with or without high-intermediate risk factors.
3. Patients with serous or clear cell histology (with or without other high-intermediate risk factors) are eligible provided the disease is uterine-confined (with or without cervical stromal invasion or endocervical glandular involvement).
5. Patients must have GOG performance status 0, 1, or 2.
6. Patients must have adequate bone marrow, renal, hepatic and neurologic function per protocol.
7. Patients who have met the pre-entry requirements specified in protocol; testing values/results must meet eligibility criteria specified in protocol.
8. Patients must have signed an approved informed consent and authorization permitting release of personal health information.
Exclusion Criteria:
1. Patients with recurrent disease.
2. Patients with GOG performance status of 3 or 4.
3. Greater than 12 weeks elapsed from surgery to enrollment.
4. Patients have prior pelvic or abdominal radiation therapy.
5. Known hypersensitivity to any component of study treatment that resulted in drug discontinuation.
6. Significant intercurrent illness including, but not limited to, unstable angina pectoris, and cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
7. Active pregnancy or lactation.
8. Prior malignancy requiring treatment within the last 3 years.References
Publications (0)
Data not yet available
No reference posted for this study.