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NCT02598349 · ClinicalTrials.gov registry record · Phase 2
Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas
A Phase 2 study of Pancreatic Cancer, sponsored by Proton Collaborative Group.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 4
- Study locations
NCT02598349: Recruiting Phase 2 study of Pancreatic Cancer, sponsored by Proton Collaborative Group.
NCT02598349 is a Phase 2 study of Pancreatic Cancer that is actively recruiting participants, run by Proton Collaborative Group. The registered enrollment target is 60 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (85% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02598349, a Phase 2 study of Pancreatic Cancer, is actively recruiting participants, sponsored by Proton Collaborative Group.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 4
- Study locations
Study Summary
The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having "borderline resectable" disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability. It may be argued that intensification of local and regional therapy might 1.) Increase the share of patients able to undergo curative surgery and 2.) Improve the local disease control interval and extend survival for patients who remain unresectable. Therefore, the purpose of this research study is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).
Primary Outcome
The trial is designed to allow detection of an improvement in the 12 month overall survival rate to 75% compared to the expected historical rate of 50%.
Conditions Studied
Interventions
- DRUG Capecitabine
- PROCEDURE Surgical resection
- RADIATION Proton Radiation
Study Locations (4)
Florida
- University of Florida Proton Therapy Institute - Jacksonville
Illinois
- Northwestern Medicine Chicago Proton Center - Warrenville
Michigan
- McLaren Proton Therapy Center - Flint
Virginia
- Inova Schar Cancer Institute - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2016-04 |
| Est. Completion | 2040-10 |
| Phase | Phase 2 |
What NCT02598349 shows while recruiting
NCT02598349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 3 interventions - of which Capecitabine is the first listed.
NCT02598349 reports a single indexed study location in Florida, Illinois, Michigan.
Frequently Asked Questions
What is clinical trial NCT02598349 about?
NCT02598349 is a clinical study titled "Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas". The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having "borderline resectable" disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resec...
What is the current status of trial NCT02598349?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2016-04. Estimated completion is 2040-10.
What conditions does trial NCT02598349 study?
This clinical trial studies the following conditions: Pancreatic Cancer.
What interventions are being tested in trial NCT02598349?
The interventions under investigation include: Capecitabine (DRUG), Surgical resection (PROCEDURE), Proton Radiation (RADIATION).
Who is sponsoring clinical trial NCT02598349?
This trial is sponsored by Proton Collaborative Group, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02598349 being conducted?
This trial has 4 study locations across Florida, Illinois, Michigan, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02598349's enrollment target sits among peer trials
60 137th of 278 higher than 138 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic 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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