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NCT01294358 · ClinicalTrials.gov registry record · Phase 1
Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT01294358: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01294358 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01294358, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: \- Pancreatic cancer is difficult to treat because by the time most cases are diagnosed, the tumors are too large to be removed surgically. Standard intravenous chemotherapy may shrink some of the tumor, but even with chemotherapy only about 25 percent of patients will live for 1 year following diagnosis. Several preliminary studies have shown that it is safe to give chemotherapy directly into the pancreas in the area of the tumor, and that giving gemcitabine over a longer period increases the amount of drug that is available to the tumor. Researchers are interested in studying whether giving the approved pancreatic cancer chemotherapy drug gemcitabine directly into the pancreas in the area of the cancer and at a slow rate of infusion is a safe and effective treatment. Objectives: \- To test the safety and effectiveness of administering gemcitabine directly to a pancreatic tumor at a slow rate of infusion. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with pancreatic cancer that is currently too large to be removed surgically but has not yet spread to other organs. Design: * Participants will be screened with a full medical history and physical examination, blood and urine tests, and imaging studies. * Participants will undergo pancreatic angiography and embolization, during which a catheter will be threaded into the blood vessels near the pancreas and a contrast dye will be used to show the blood vessels supplying the tumor. These blood vessels will then be surgically closed off. * After the embolization, gemcitabine will be given as an infusion into the area around the tumor over 24 hours. * Participants will return to the clinical center every 2 weeks after the first infusion for additional infusions of gemcitabine, using the same procedures as above. Participants will be monitored with frequent blood tests and imaging studies. * Two weeks after the fourth treatment (course 1), participants will have more imaging
Interventions
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2011-01-26 |
| Est. Completion | 2014-07-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01294358
The ClinicalTrials.gov registry entry for NCT01294358 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gemcitabine is the first listed.
NCT01294358 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01294358 about?
NCT01294358 is a clinical study titled "Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial". Background: \- Pancreatic cancer is difficult to treat because by the time most cases are diagnosed, the tumors are too large to be removed surgically. Standard intravenous chemotherapy may shrink some of the tumor, but even with chemotherapy only about 25 percent of patients will live for 1 year f...
What is the current status of trial NCT01294358?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2011-01-26. Estimated completion is 2014-07-23.
What interventions are being tested in trial NCT01294358?
The interventions under investigation include: Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT01294358?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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