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NCT04106856 · ClinicalTrials.gov registry record · Phase 1
Losartan and Hypofractionated Rx After Chemo for Tx of Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer (SHAPER)
A Phase 1 study of Stage III Pancreatic Cancer AJCC v8 and Stage II Pancreatic Cancer AJCC v8, sponsored by University of Utah.
- Active
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT04106856: Active Phase 1 study of Stage III Pancreatic Cancer AJCC v8 and Stage II Pancreatic Cancer AJCC v8, sponsored by University of Utah.
NCT04106856 is a Phase 1 study of Stage III Pancreatic Cancer AJCC v8 and Stage II Pancreatic Cancer AJCC v8 that is active but no longer recruiting, run by University of Utah. The registered enrollment target is 22 participants, below the 59-participant average among 23 other Stage III Pancreatic Cancer AJCC v8 trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04106856, a Phase 1 study of Stage III Pancreatic Cancer AJCC v8 and Stage II Pancreatic Cancer AJCC v8, is active but no longer recruiting, sponsored by University of Utah.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects of losartan and hypofractionated radiation therapy after chemotherapy in treating patients with pancreatic cancer that may or may not be removed by surgery (borderline resectable) or has spread from its original site of growth to nearby tissues or lymph nodes and is not amenable to surgical resection (locally advanced unresectable). Losartan may improve blood flow and allows for better tissue oxygenation. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving losartan and hypofractionated radiation therapy may work better in treating patients with pancreatic cancer compared to hypofractionated radiation therapy alone.
Primary Outcome
A DLT is an event that occurred less than or equal to 84 days of finishing RT, has a possible causal relationship with lstudy treatment, and is one of the following: * Any grade ≥ 4 GI-related event; or * A grade ≥ 3 * Gastric or duodenal ulcer; * Gastric, small bowel, or colonic hemorrhage from areas inside the hdPTV or pPTV; * Gastric or small bowel obstruction or stenosis located to areas inside the hdPTV or pPTV; * Gastrointestinal fistula in areas inside the hdPTV or pPTV; * Gas
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- RADIATION Hypofractionated Radiation Therapy
- DRUG Losartan
- DRUG Losartan Potassium
Study Locations (1)
Utah
- Huntsman Cancer Institute/University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2019-08-08 |
| Est. Completion | 2026-08-08 |
| Phase | Phase 1 |
What the registry record for NCT04106856 still lists
NCT04106856 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 59-participant average among 23 other Stage III Pancreatic Cancer AJCC v8 trials with a reported enrollment target (63% lower).
The record links to 7 conditions, with Stage III Pancreatic Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04106856 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT04106856 about?
NCT04106856 is a clinical study titled "Losartan and Hypofractionated Rx After Chemo for Tx of Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer (SHAPER)". This phase I trial studies the side effects of losartan and hypofractionated radiation therapy after chemotherapy in treating patients with pancreatic cancer that may or may not be removed by surgery (borderline resectable) or has spread from its original site of growth to nearby tissues or lymph no...
What is the current status of trial NCT04106856?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2019-08-08. Estimated completion is 2026-08-08.
What conditions does trial NCT04106856 study?
This clinical trial studies the following conditions: Stage III Pancreatic Cancer AJCC v8, Stage II Pancreatic Cancer AJCC v8, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma, Stage IIA Pancreatic Cancer AJCC v8.
What interventions are being tested in trial NCT04106856?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Hypofractionated Radiation Therapy (RADIATION), Losartan (DRUG), Losartan Potassium (DRUG).
Who is sponsoring clinical trial NCT04106856?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04106856 being conducted?
This trial has 1 study location across Utah. 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 NCT04106856's enrollment target sits among peer trials
22 18th of 23 higher than 6 of 23 other Stage III Pancreatic Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Pancreatic Cancer AJCC v8 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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