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NCT01360593 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma
A Phase 2 study, sponsored by David A. Clump, MD, PhD.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT01360593: Completed Phase 2 study, sponsored by David A. Clump, MD, PhD.
NCT01360593 is a Phase 2 study that has completed, run by David A. Clump, MD, PhD. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01360593, a Phase 2 study, has completed, sponsored by David A. Clump, MD, PhD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
The current study seeks to further investigate the impact of up-front systemic therapy in combination with fractionated SBRT for potentially resectable, locally-advanced pancreatic adenocarcinoma.
Primary Outcome
LPFS is defined as the time from enrollment to first documentation of progressive disease (PD) in the target lesion. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume. Death or development of distant disease is not regarded as an event. Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, progressive disease is defined as at least a 25% inc
Interventions
- DRUG Capecitabine
- DRUG Gemcitabine
- RADIATION Stereotactic Body Radiation Therapy (SBRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2011-07-25 |
| Est. Completion | 2018-10 |
| Phase | Phase 2 |
What the finished NCT01360593 record still lists
NCT01360593 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 3 interventions - of which Capecitabine is the first listed.
NCT01360593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01360593 about?
NCT01360593 is a clinical study titled "Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma". The current study seeks to further investigate the impact of up-front systemic therapy in combination with fractionated SBRT for potentially resectable, locally-advanced pancreatic adenocarcinoma.
What is the current status of trial NCT01360593?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2011-07-25. Estimated completion is 2018-10.
What interventions are being tested in trial NCT01360593?
The interventions under investigation include: Capecitabine (DRUG), Gemcitabine (DRUG), Stereotactic Body Radiation Therapy (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT01360593?
This trial is sponsored by David A. Clump, MD, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01360593's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 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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