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NCT04743999 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Outcomes in Women Undergoing Multimodality Treatment for Advanced Stage Endometrial Carcinoma
A Phase 2 study, sponsored by Henry Ford Health System.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT04743999 is a Phase 2 study that was terminated before completion, run by Henry Ford Health System. The registered enrollment target is 9 participants.
The verdict
NCT04743999, a Phase 2 study, was terminated before completion, sponsored by Henry Ford Health System.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
Patients with FIGO stage III endometrial carcinoma often require multimodality adjuvant therapy to improve survival and recurrence rates; however, the optimal adjuvant therapy sequence is yet to be established. Several studies have tried to answer this question including RTOG 9708, PORTEC-3, and GOG 258. Collectively, these studies show that concurrent chemotherapy and radiation (chemoRT) with cisplatin followed by additional chemotherapy (CT) and CT alone are acceptable regimens. However, both strategies show that distant recurrence remains a problem when CT is delayed after RT, and local control is compromised without RT. We wish to prospectively assess outcomes of women with advanced endometrial carcinoma who receive concurrent chemoRT with a carboplatin/paclitaxel-based regimen. A total of 60 patients with FIGO stage III uterine carcinoma will be prospectively enrolled after undergoing surgical staging (currently accruing). CT will start approximately 4 weeks after surgery. Patients will receive 6 cycles of carboplatin (AUC 6) and paclitaxel (175 mg/m2). RT will be given during CT cycles 1-3. External beam RT will be given via intensity-modulated RT in once-daily fractions of 1.8-2.0 Gy for a total dose of 44-45 Gy to the pelvis (vaginal cuff, pelvic LN, and para-aortic lymph nodes). If there is grossly visible nodal disease seen at the time of treatment planning, a boost to 54 Gy will be given to those areas. If the patient has cervical stromal invasion, we will recommend that she receive a brachytherapy boost. Data will be collected on OS and PFS endpoints. Data will also be collected on provider- and patient-reported treatment toxicity. Patients will receive a series of questionnaires at baseline, 3, 6, 12, and 24 months after surgery. These are prospectively-validated questionnaires and include FACT-G, FACT-En, FACT/GOG-NTX, and FACT-C. For statistical analyses, continuous and categorical variables will be analyzed. Kaplan-Meier survival estimates will
Interventions
- OTHER Quality of life questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-02-27 |
| Est. Completion | 2023-06-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04743999
The ClinicalTrials.gov registry entry for NCT04743999 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry Ford Health System, which has 234 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Quality of life questionnaire is the first listed.
NCT04743999 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04743999 about?
NCT04743999 is a clinical study titled "Evaluation of Outcomes in Women Undergoing Multimodality Treatment for Advanced Stage Endometrial Carcinoma". Patients with FIGO stage III endometrial carcinoma often require multimodality adjuvant therapy to improve survival and recurrence rates; however, the optimal adjuvant therapy sequence is yet to be established. Several studies have tried to answer this question including RTOG 9708, PORTEC-3, and GO...
What is the current status of trial NCT04743999?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2020-02-27. Estimated completion is 2023-06-27.
What interventions are being tested in trial NCT04743999?
The interventions under investigation include: Quality of life questionnaire (OTHER).
Who is sponsoring clinical trial NCT04743999?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
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