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NCT03064490 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab, Radiotherapy, and Chemotherapy in Neoadjuvant Treatment of Malignant Esophago-gastric Diseases (PROCEED)
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT03064490 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 35 participants.
The verdict
NCT03064490, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a single-institution, prospective phase II trial with an initial safety run-in to evaluate the efficacy and safety of neoadjuvant pembrolizumab combined with chemoradiotherapy and adjuvant pembrolizumab in patients with locally advanced esophageal and gastric cancers (EGC). Chemoradiation therapy (45Gy in 25 fractions with concurrent, weekly carboplatin \[AUC 2\] and paclitaxel \[50mg/m2 of BSA\]) with three cycles of pembrolizumab will be administered as neoadjuvant therapy. These patients will also receive three cycles of adjuvant pembrolizumab after surgical resection
Interventions
- DRUG Pembrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2017-10-17 |
| Est. Completion | 2023-11-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03064490
The ClinicalTrials.gov registry entry for NCT03064490 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pembrolizumab is the first listed.
NCT03064490 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03064490 about?
NCT03064490 is a clinical study titled "Pembrolizumab, Radiotherapy, and Chemotherapy in Neoadjuvant Treatment of Malignant Esophago-gastric Diseases (PROCEED)". This is a single-institution, prospective phase II trial with an initial safety run-in to evaluate the efficacy and safety of neoadjuvant pembrolizumab combined with chemoradiotherapy and adjuvant pembrolizumab in patients with locally advanced esophageal and gastric cancers (EGC). Chemoradiation th...
What is the current status of trial NCT03064490?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2017-10-17. Estimated completion is 2023-11-22.
What interventions are being tested in trial NCT03064490?
The interventions under investigation include: Pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT03064490?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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