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NCT03073785 · ClinicalTrials.gov registry record · Phase 2
Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer
A Phase 2 study of Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v6 and v7, sponsored by University of Nebraska.
- Active
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT03073785: Active Phase 2 study of Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v6 and v7, sponsored by University of Nebraska.
NCT03073785 is a Phase 2 study of Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v6 and v7 that is active but no longer recruiting, run by University of Nebraska. The registered enrollment target is 46 participants, below the 99,464-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03073785, a Phase 2 study of Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v6 and v7, is active but no longer recruiting, sponsored by University of Nebraska.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
Pancreatic cancer, most commonly adenocarcinoma, is the fourth leading cause of cancer death in the United States. The mainstay of management centers on surgical resection (if resectable) and although low (15% to 20%), resectability rates are associated with dismal survival. An estimated 80% to 85% of the patients recur after surgical resection, leading to a median survival of 20 to 24 months and potentially even less depending on lymph nodal involvement or positive margins. The rationale for utilizing neoadjuvant therapy, commonly fluoropyrimidine-based or gemcitabine based chemotherapy or Chemoradiotherapy (CRT), involves possibly down staging borderline resectable and unresectable patients, potentially making them resectable candidates. This randomized phase II trial will study how well hypofractionated stereotactic body radiation therapy (SBRT) and fluorouracil or capecitabine with or without zoledronic acid work in treating participants with pancreatic cancer that has spread to nearby tissue or lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor using smaller doses over several days which may cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Zoledronic acid is used in cancer patients to reduce cancer symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid may work better in treating pancreatic cancer.
Primary Outcome
Local control of tumor will be determined by four dimensional (4D) computed tomography (CT) scans and comparison made between participants receiving Zometa and those who don't.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Fluorouracil
- RADIATION Stereotactic Body Radiation Therapy
- OTHER Laboratory Biomarker Analysis
- OTHER Pharmacological Study
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2016-09-16 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What the registry record for NCT03073785 still lists
NCT03073785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 99,464-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower).
The record links to 10 conditions, with Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT03073785 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT03073785 about?
NCT03073785 is a clinical study titled "Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer". Pancreatic cancer, most commonly adenocarcinoma, is the fourth leading cause of cancer death in the United States. The mainstay of management centers on surgical resection (if resectable) and although low (15% to 20%), resectability rates are associated with dismal survival. An estimated 80% to 85% ...
What is the current status of trial NCT03073785?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2016-09-16. Estimated completion is 2027-12.
What conditions does trial NCT03073785 study?
This clinical trial studies the following conditions: Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v6 and v7, Recurrent Pancreatic Carcinoma, Stage III Pancreatic Cancer AJCC v6 and v7, Stage II Pancreatic Cancer AJCC v6 and v7.
What interventions are being tested in trial NCT03073785?
The interventions under investigation include: Capecitabine (DRUG), Fluorouracil (DRUG), Stereotactic Body Radiation Therapy (RADIATION), Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT03073785?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03073785 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03073785's enrollment target sits among peer trials
46 36th of 62 higher than 26 of 62 other Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Adenocarcinoma 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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