NCT03652428Active, not recruitingPhase 1/2
Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)
Phase I Study of Concurrent Nab-Paclitaxel + Gemcitabine With Hypofractionated, Ablative Proton Therapy for Locally Advanced Pancreatic Cancer
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 22 Aug 2018
- Start date
- 2 Apr 2019
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Pancreatic cancer
- NCT number
- NCT03652428
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 24
- From 2 Apr 2019 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No prior definitive resection of pancreatic cancer.
- No prior radiation therapy to the abdomen that would overlap fields required in this study. Prior radiotherapy for other disease is allowed.
- No prior chemotherapy except for FOLFIRINOX, Gem-Abrax, or Gem-Cap. A patient may be registered for the trial while undergoing chemotherapy.
- Any grade 4 toxicity prior to start of chemoradiotherapy that may be due to induction chemotherapy.
- Greater than 2 dose reductions during induction chemotherapy.
- Chronic concomitant treatment with strong inhibitors of CYP3A4. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to the start of study treatment. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment.
- Non-compliance with induction chemotherapy.
Other illness
- Patients with resectable or borderline resectable pancreatic cancer are ineligible.
- Baseline Grade ≥ 2 neuropathy. Known Gilbert's disease or known homozygosity for UGAT1A1\*28 polymorphism.
- Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with gemcitabine and nab-paclitaxel.
Other
- Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of study entry if they are in childbearing years/premenopausal.
Who the study is looking for
- Cytologic or histologic proof of adenocarcinoma of the pancreas.
- Nonmetastatic pancreatic cancer. Metastatic disease includes spread to distant (non-regional) lymph nodes, organs, peritoneum and ascites.
- Unequivocal radiographic findings contraindicating resection including, but not limited to, solid tumor contact with any of the following: 1) the SMA \>180º; 2) the celiac axis \>180º; 3) the first jejunal superior mesenteric artery (SMA) branch; 4) unreconstructible superior mesenteric vein (SMV)/portal vein due to tumor involvement or occclusion; 5) the most proximal draining jejunal branch into the SMV.
- ECOG Performance Status 0 or 1.
- Absolute neutrophil count ≥1,000/mm3
- Platelet count ≥100,000/mm3
- Creatinine ≤1.5 × upper limit of normal
- Calculated creatinine clearance \>45 mL/min
- Total bilirubin ≤2 mg/dL
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Maryland Medical Center/Maryland Proton Treatment Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| MedStar Georgetown University Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.