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NCT01821729 · ClinicalTrials.gov registry record · Phase 2
Radiation w/FOLFIRINOX-Losartan for Pancreatic Cancer
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01821729: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT01821729 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01821729, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
This is a Phase II clinical trial, which tests the safety and effectiveness of an investigational combination of drugs to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is being studied. It also means that the FDA has not yet approved it for your type of cancer. Proton beam radiation therapy is an FDA approved radiation delivery system. Conventional radiation therapy uses photons to treat cancer before patients undergo surgery to remove the tumor. In this study we are using radiation with protons, which spares surrounding tissue and organs from radiation. Proton radiation delivers radiation to the area requiring radiation with no dose beyond the treatment area. This may reduce side effects that patients would normally experience with conventional radiation therapy. Researchers in the laboratory have discovered pathways inside cancer cells which contribute to the growth and survival of tumors. The FOLFIRINOX chemotherapy regimen is a combination of the drugs 5-fluorouracil, leucovorin and oxaliplatin. These chemotherapy drugs, along with the chemotherapy drug capecitabine, work by blocking these pathways and thereby preventing tumor growth. Capecitabine is FDA approved to be used alone or with other drugs to treat other types of advanced cancer, but not pancreatic cancer. In past research studies, FOLFIRINOX followed by radiation therapy with capecitabine has been identified as the most effective and active chemotherapy for patients with cancer that is spreading, and this is why we are using it to treat your type of cancer. Losartan is classified as an angiotensin-receptor blocker (ARB), and is FDA approved for use in people with high blood pressure. Recent studies in people with different types of cancer, including pancreatic cancer, have shown that combining chemotherapy drugs with an ARB can help reduce/stop tumor growth more effectively than chemotherapy alone. Losartan has been
Primary Outcome
R0 resection means that no cancer cells were seen microscopically at the surgical resection margin.
Interventions
- DRUG Losartan
- DRUG FOLFIRINOX
- RADIATION Proton Beam Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-08-16 |
| Est. Completion | 2022-05-11 |
| Phase | Phase 2 |
What the finished NCT01821729 record still lists
NCT01821729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 3 interventions - of which Losartan is the first listed.
NCT01821729 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01821729 about?
NCT01821729 is a clinical study titled "Radiation w/FOLFIRINOX-Losartan for Pancreatic Cancer". This is a Phase II clinical trial, which tests the safety and effectiveness of an investigational combination of drugs to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is being studied. It also means that the FDA has...
What is the current status of trial NCT01821729?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2013-08-16. Estimated completion is 2022-05-11.
What interventions are being tested in trial NCT01821729?
The interventions under investigation include: Losartan (DRUG), FOLFIRINOX (DRUG), Proton Beam Radiation (RADIATION).
Who is sponsoring clinical trial NCT01821729?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01821729's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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