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NCT03490292 · ClinicalTrials.gov registry record · Phase 1
Avelumab With Chemoradiation for Stage II/III Resectable Esophageal and Gastroesophageal Cancer
A Phase 1 study of GastroEsophageal Cancer and Resectable Esophageal Cancer, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT03490292: Completed Phase 1 study of GastroEsophageal Cancer and Resectable Esophageal Cancer, sponsored by University of Wisconsin, Madison.
NCT03490292 is a Phase 1 study of GastroEsophageal Cancer and Resectable Esophageal Cancer that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 22 participants, below the 496-participant average among 23 other GastroEsophageal Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03490292, a Phase 1 study of GastroEsophageal Cancer and Resectable Esophageal Cancer, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 2 part Phase I/II clinical trial evaluating the safety, tolerability and efficacy of avelumab in combination with chemoradiation in patients with resectable esophageal and gastroesophageal cancer. Part 1: This is the run-in phase of the trial. This portion will determine the safety and tolerability of avelumab in combination with chemoradiotherapy in 6 patients. The proposed combination will be considered as safe if dose limiting toxicities are observed in at most 1 patient. Part 2: This is a Phase 2 portion of the trial, which will evaluate the efficacy of the proposed treatment regimen in patients with stage II/III resectable esophageal and gastroesophageal cancer
Primary Outcome
A total number of 6 subjects will be enrolled during the run-in phase of the trial. A sample size of 6 is sufficient to estimate the true dose limiting toxicity rate of the proposed avelumab/chemoradiation therapy with adequate accuracy.The proposed treatment combination will be considered as safe if dose limiting toxicities are observed in at most 1 patient.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- RADIATION Radiation
- COMBINATION_PRODUCT Avelumab combined with Chemoradiation
Study Locations (1)
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-05-29 |
| Est. Completion | 2023-07-12 |
| Phase | Phase 1 |
What the finished NCT03490292 record still lists
NCT03490292 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 496-participant average among 23 other GastroEsophageal Cancer trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with GastroEsophageal Cancer appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT03490292 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03490292 about?
NCT03490292 is a clinical study titled "Avelumab With Chemoradiation for Stage II/III Resectable Esophageal and Gastroesophageal Cancer". This is a 2 part Phase I/II clinical trial evaluating the safety, tolerability and efficacy of avelumab in combination with chemoradiation in patients with resectable esophageal and gastroesophageal cancer. Part 1: This is the run-in phase of the trial. This portion will determine the safety and to...
What is the current status of trial NCT03490292?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2018-05-29. Estimated completion is 2023-07-12.
What conditions does trial NCT03490292 study?
This clinical trial studies the following conditions: GastroEsophageal Cancer, Resectable Esophageal Cancer.
What interventions are being tested in trial NCT03490292?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Radiation (RADIATION), Avelumab combined with Chemoradiation (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03490292?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03490292 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03490292's enrollment target sits among peer trials
22 20th of 23 higher than 4 of 23 other GastroEsophageal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other GastroEsophageal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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