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NCT03652428 · ClinicalTrials.gov registry record · Phase 1
Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)
A Phase 1 study of Locally Advanced Pancreatic Cancer, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT03652428: Recruiting Phase 1 study of Locally Advanced Pancreatic Cancer, sponsored by University of Maryland, Baltimore.
NCT03652428 is a Phase 1 study of Locally Advanced Pancreatic Cancer that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 24 participants, below the 113-participant average among 3 other Locally Advanced Pancreatic Cancer trials with a reported enrollment target (79% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03652428, a Phase 1 study of Locally Advanced Pancreatic Cancer, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to determine the maximum tolerated dose of the chemotherapy drugs nab-paclitaxel and gemcitabine when combined with hypofractionated ablative proton therapy for the treatment of locally advanced pancreatic cancer. You will receive proton therapy once a day (Monday - Friday) for 3 weeks. Participants will also receive chemotherapy on each Monday of those three weeks.
Primary Outcome
Maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of concurrent nab-paclitaxel + gemcitabine combined with hypofractionated ablative proton therapy for the treatment of locally advanced pancreatic cancer.
Conditions Studied
Interventions
- DRUG Gemcitabine
- RADIATION Hypofractionated Ablative Proton Therapy
Study Locations (2)
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Maryland
- University of Maryland Medical Center/Maryland Proton Treatment Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-04-02 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT03652428 shows while recruiting
NCT03652428 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 113-participant average among 3 other Locally Advanced Pancreatic Cancer trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Locally Advanced Pancreatic Cancer appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine is the first listed.
NCT03652428 reports a single indexed study location in District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT03652428 about?
NCT03652428 is a clinical study titled "Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)". The purpose of this study is to determine the maximum tolerated dose of the chemotherapy drugs nab-paclitaxel and gemcitabine when combined with hypofractionated ablative proton therapy for the treatment of locally advanced pancreatic cancer. You will receive proton therapy once a day (Monday - Frid...
What is the current status of trial NCT03652428?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-04-02. Estimated completion is 2026-12-31.
What conditions does trial NCT03652428 study?
This clinical trial studies the following conditions: Locally Advanced Pancreatic Cancer.
What interventions are being tested in trial NCT03652428?
The interventions under investigation include: Gemcitabine (DRUG), Hypofractionated Ablative Proton Therapy (RADIATION).
Who is sponsoring clinical trial NCT03652428?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03652428 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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