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NCT02207465 · ClinicalTrials.gov registry record · Phase 1
A Phase I Dual Dose Escalation Study of Radiation and Nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer
A Phase 1 study of Locally Advanced Unresectable Pancreatic Cancer Treated With Chemoradiotherapy and Borderline Resectable Pancreatic Cancer Treated With Chemoradiotherapy, sponsored by Abramson Cancer Center at Penn Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 2
- Study locations
NCT02207465: Active Phase 1 study of Locally Advanced Unresectable Pancreatic Cancer Treated With Chemoradiotherapy and Borderline Resectable Pancreatic Cancer Treated With Chemoradiotherapy, sponsored by Abramson Cancer Center at Penn Medicine.
NCT02207465 is a Phase 1 study of Locally Advanced Unresectable Pancreatic Cancer Treated With Chemoradiotherapy and Borderline Resectable Pancreatic Cancer Treated With Chemoradiotherapy that is active but no longer recruiting, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02207465, a Phase 1 study of Locally Advanced Unresectable Pancreatic Cancer Treated With Chemoradiotherapy and Borderline Resectable Pancreatic Cancer Treated With Chemoradiotherapy, is active but no longer recruiting, sponsored by Abramson Cancer Center at Penn Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 2
- Study locations
Study Summary
The investigators hypothesize that intensification of local therapy will lead to improvements in local control and survival in patients with unresectable and borderline resectable pancreatic cancer. We propose to do this by combining nab-paclitaxel concurrently with dose-escalated radiation therapy. In the first part of this phase I study (sub-trial 1), the nab-paclitaxel dose will be escalated while the radiation dose is held constant at a standardly accepted level. The use of this novel chemoradiotherapy regimen will take advantage of nab-paclitaxel's specific anti-tumor and anti-stromal properties, which may enhance the efficacy of radiation therapy, and thereby improve local control. After the MTD of nab-paclitaxel had been determined, a second arm in sub-trial 1 will evaluate the addition of paricalcitol to nab-paclitaxel concurrently with dose-escalated radiation therapy. In addition, after the MTD of the nab-paclitaxel is reached in sub-trial 1 arm A, in the second part of this study (sub-trial 2), we will administer nab-paclitaxel at the determined MTD concurrently with escalated doses of radiation. We will utilize IMRT or protons to safely deliver high doses of radiation while maximally sparing surrounding normal tissue. Patients will also preferentially have 2-3 fiducial markers placed in or around the tumor for daily localization. Chemotherapy before and/or after chemoradiotherapy may be given as per standard of care. Correlative tissue and serum biomarkers are an important, but optional, part of this study.
Conditions Studied
Interventions
- RADIATION Radiotherapy
- DRUG Abraxane
Study Locations (2)
Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania - Philadelphia
- Chester County Hospital - West Chester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2014-07 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What the registry record for NCT02207465 still lists
NCT02207465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 2 conditions, with Locally Advanced Unresectable Pancreatic Cancer Treated With Chemoradiotherapy appearing as the primary indexed condition, and to 2 interventions - of which Radiotherapy is the first listed.
NCT02207465 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02207465 about?
NCT02207465 is a clinical study titled "A Phase I Dual Dose Escalation Study of Radiation and Nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer". The investigators hypothesize that intensification of local therapy will lead to improvements in local control and survival in patients with unresectable and borderline resectable pancreatic cancer. We propose to do this by combining nab-paclitaxel concurrently with dose-escalated radiation therapy....
What is the current status of trial NCT02207465?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2014-07. Estimated completion is 2026-12.
What conditions does trial NCT02207465 study?
This clinical trial studies the following conditions: Locally Advanced Unresectable Pancreatic Cancer Treated With Chemoradiotherapy, Borderline Resectable Pancreatic Cancer Treated With Chemoradiotherapy.
What interventions are being tested in trial NCT02207465?
The interventions under investigation include: Radiotherapy (RADIATION), Abraxane (DRUG).
Who is sponsoring clinical trial NCT02207465?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02207465 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02207465's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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