Proton beam plus chemo: a new hope for pancreatic cancer?
NCT ID NCT03652428
First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times
Summary
This study is testing a combination of two chemotherapy drugs (gemcitabine and nab-paclitaxel) with a precise type of radiation called proton therapy for people with locally advanced pancreatic cancer that cannot be removed by surgery. The goal is to find the highest safe dose of the chemo drugs when given with the radiation. Participants will receive proton therapy daily for three weeks and chemo once a week during that time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gemcitabine and nab-paclitaxel (chemotherapy drugs) plus proton radiation therapy
- What this could lead to
- If successful, this could lead to a more effective treatment option for locally advanced pancreatic cancer that may shrink tumors and improve survival.
- What could go wrong
- This is an early-phase trial with only 24 participants, so results may not apply broadly. The combination of chemo and radiation can cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2019
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Cytologic or histologic proof of adenocarcinoma of the pancreas. 2. Nonmetastatic pancreatic cancer. Metastatic disease includes spread to distant (non-regional) lymph nodes, organs, peritoneum and ascites. 3. 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. 4. ECOG Performance Status 0 or 1. 5. Absolute neutrophil count ≥1,000/mm3 6. Platelet count ≥100,000/mm3 7. Creatinine ≤1.5 × upper limit of normal 8. Calculated creatinine clearance \>45 mL/min 9. Total bilirubin ≤2 mg/dL Exclusion Criteria: 1. Patients with resectable or borderline resectable pancreatic cancer are ineligible. 2. No prior definitive resection of pancreatic cancer. 3. No prior radiation therapy to the abdomen that would overlap fields required in this study. Prior radiotherapy for other disease is allowed. 4. No prior chemotherapy except for FOLFIRINOX, Gem-Abrax, or Gem-Cap. A patient may be registered for the trial while undergoing chemotherapy. 5. Any grade 4 toxicity prior to start of chemoradiotherapy that may be due to induction chemotherapy. 6. Greater than 2 dose reductions during induction chemotherapy. 7. 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. 8. Baseline Grade ≥ 2 neuropathy. Known Gilbert's disease or known homozygosity for UGAT1A1\*28 polymorphism. 9. Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of study entry if they are in childbearing years/premenopausal. 10. Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with gemcitabine and nab-paclitaxel. 11. Non-compliance with induction chemotherapy.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Locally advanced pancreatic cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
-
University of Maryland Medical Center/Maryland Proton Treatment Center
Baltimore, Maryland, 21201, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two oral drugs join chemotherapy in a bid to shrink pancreatic tumors
- Can a Triple-Drug combo outsmart pancreatic cancer?
- New personalized vaccine takes on tough cancers
- New radiation bead treatment targets Hard-to-Treat pancreatic tumors
- New catheter targets pancreatic cancer tumors directly
- New hope for pancreatic cancer? drug combo trial launches