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Proton beam plus chemo: a new hope for pancreatic cancer?

NCT ID NCT03652428

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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