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Can a triple therapy shrink pancreatic tumors enough for complete surgery?

NCT ID NCT01591733

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This phase II trial tests whether giving chemotherapy and proton beam radiation before surgery can help people with borderline-resectable pancreatic cancer. The goal is to shrink the tumor enough so that surgeons can remove it completely, with no cancer cells left at the edges. Participants receive FOLFIRINOX chemotherapy, then capecitabine with short-course radiation, followed by surgery. Researchers will measure how often the tumor is fully removed and how long people live without the cancer progressing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of chemotherapy drugs (FOLFIRINOX and capecitabine), proton beam radiation, and surgery
What this could lead to
If successful, this approach could increase the chance of completely removing the tumor during surgery, potentially improving long-term control of pancreatic cancer.
What could go wrong
This is a phase II trial with a small number of participants, so results may not be definitive. The chemotherapy and radiation can cause significant side effects, and the tumor may still not be fully removable.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

48 people

The number who actually took part.

Started

Aug 2012

Finished

Apr 2021

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 years and older

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: * Cytologic or histologic proof pancreatic ductal carcinoma * Borderline resectable * Life expectancy of at least 3 months * ECOG Performance Status ≤ 1 * Adequate organ and bone marrow function * No treatment of other invasive cancers within the last 5 years with greater than 5% risk of recurrence at the time of eligibility screening. Carcinoma in-situ and basal cell carcinoma/squamous cell carcinoma of the skin are allowed * \> 4 weeks since major surgery, excluding laparoscopy Exclusion Criteria: * Evidence of metastatic disease * Pregnant or breastfeeding * Other serious uncontrolled medical conditions * Prior chemotherapy, targeted/biologic therapy or radiation for treatment of the pancreatic tumor * Prior systemic fluoropyrimidine therapy * History of uncontrolled seizures, central nervous system disorders or psychiatric disability * Individuals on cimetidine

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatic cancer

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

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