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Promising cocktail may shrink pancreatic tumors before surgery

NCT ID NCT01821729

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase II trial tested a combination of chemotherapy drugs (FOLFIRINOX) plus the blood pressure drug losartan, followed by proton radiation, in 50 people with locally advanced pancreatic cancer. The goal was to see if this approach could shrink tumors enough to allow complete surgical removal. The study focused on safety and how many patients achieved a clean surgical margin.

What this could mean

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

Active substance
FOLFIRINOX (combination of 5-fluorouracil, leucovorin, oxaliplatin, irinotecan), losartan, capecitabine, and proton beam radiation
What this could lead to
If successful, this combination could improve the chance of surgically removing pancreatic tumors with clear margins, potentially extending survival.
What could go wrong
This is a small Phase II study with only 50 participants, so results may not apply broadly. The combination has significant side effects and may not improve outcomes over standard therapy.

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

50 people

The number who actually took part.

Started

Aug 2013

Finished

May 2022

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 * Locally advanced, unresectable disease * Life expectancy of at least 3 months Exclusion Criteria: * Evidence of metastatic disease * Pregnant or breastfeeding * Serious concomitant systemic disorders incompatible with the study * Already treated on ACE or ARB therapy for hypertension or renal protection at the time of enrollment * Baseline hypotension * Prior chemotherapy, radiation therapy, or biologic therapy for treatment of pancreatic tumor * Treatment for other invasive carcinomas within the last 5 years who are 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) * Other serious uncontrolled medical conditions * Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome * Known, existing coagulopathy * Prior systemic fluoropyrimidine therapy * Participation in any investigational drug study within 4 weeks preceding the start of study treatment * History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance or oral drug intake * Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment * Taking cimetidine * Receiving other study agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-fluorouracil, irinotecan, oxaliplatin or losartan

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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

Other studies related to the condition(s) this trial covers.