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NCT02780648 · ClinicalTrials.gov registry record · NA
Respiratory-gated Stereotactic Body Radiation Therapy for Adenocarcinoma of the Pancreas or Periampullary Region
A NA study of Pancreatic Neoplasms, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT02780648: Completed NA study of Pancreatic Neoplasms, sponsored by Indiana University.
NCT02780648 is a NA study of Pancreatic Neoplasms that has completed, run by Indiana University. The registered enrollment target is 36 participants, below the 600-participant average among 30 other Pancreatic Neoplasms trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02780648, a NA study of Pancreatic Neoplasms, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a single center, single arm unblinded prospective study of the safety of pancreatic stereotactic body radiation therapy (SBRT) in patients with unresectable, borderline resectable, or recurrent pancreatic/periampullary cancers who have previously undergone treatment with chemotherapy, surgery, photodynamic therapy, conventionally fractionated radiation treatment, or any combination of these therapies. Primary Objective • To estimate rates of acute (within 3 months of treatment) grade 3 or greater gastrointestinal and hematologic toxicity in patients treated with Linac-based SBRT for pancreatic or periampullary cancers who have previously received other treatment. Secondary Objectives * To estimate rates of late (\> 3 months after treatment) grade 2 gastritis, enteritis, fistula, and ulcer, or any other grade 3 or greater gastrointestinal toxicity in patients treated with Linac-based SBRT for pancreatic or periampullary cancers * To estimate rates of local progression, overall survival, metastasis-free survival, and progression-free survival in patients with pancreatic or periampullary cancers treated with fractionated Linac-based SBRT. * To evaluate the ability of Linac-based SBRT to provide pain control in patients with pain related to a pancreatic or periampullary tumor. * To evaluate quality of life in patients undergoing treatment with Linac-based SBRT for pancreatic or periampullary cancers.
Primary Outcome
Measures include the percentage of patients who experienced the toxicity with a grade of 3 or higher. Only those adverse events that were related to stereotactic body radiation therapy (SBRT) were considered. Patients were considered at risk for an adverse event if they started SBRT treatment. Toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
Conditions Studied
Interventions
- RADIATION Stereotactic Body Radiation
Study Locations (2)
Indiana
- Indiana University Health Hospital - Indianapolis
- Indiana University Health Melvin and Bren Simon Cancer Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2016-05-01 |
| Est. Completion | 2025-05-15 |
| Phase | NA |
What the finished NCT02780648 record still lists
NCT02780648 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 600-participant average among 30 other Pancreatic Neoplasms trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Pancreatic Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Stereotactic Body Radiation is the first listed.
NCT02780648 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT02780648 about?
NCT02780648 is a clinical study titled "Respiratory-gated Stereotactic Body Radiation Therapy for Adenocarcinoma of the Pancreas or Periampullary Region". This is a single center, single arm unblinded prospective study of the safety of pancreatic stereotactic body radiation therapy (SBRT) in patients with unresectable, borderline resectable, or recurrent pancreatic/periampullary cancers who have previously undergone treatment with chemotherapy, surger...
What is the current status of trial NCT02780648?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2016-05-01. Estimated completion is 2025-05-15.
What conditions does trial NCT02780648 study?
This clinical trial studies the following conditions: Pancreatic Neoplasms.
What interventions are being tested in trial NCT02780648?
The interventions under investigation include: Stereotactic Body Radiation (RADIATION).
Who is sponsoring clinical trial NCT02780648?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02780648 being conducted?
This trial has 2 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02780648's enrollment target sits among peer trials
36 23rd of 30 higher than 8 of 30 other Pancreatic Neoplasms trials
participants (enrollment target), bucketed by value
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