High-Dose Radiation + Chemotherapy for Pancreatic Cancer
(MAIBE Trial)

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen ByMarsha Reyngold, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study is being done to test whether receiving a dose of radiation that is higher than the standard dose, in combination with chemotherapy, improves the chance of becoming a candidate for surgery and improves the chance of extending the patient's life.

Eligibility Criteria

This trial is for adults with advanced pancreatic cancer who've completed at least 3 months of standard chemotherapy without distant metastasis. They must have good organ function, no prior abdominal radiotherapy, and not be pregnant or breastfeeding. Men and women must agree to use contraception.

Inclusion Criteria

Your platelet count is higher than 75,000 per microliter.

My cancer is a type of pancreatic cancer confirmed by a biopsy.

My cancer has not spread to distant parts of my body after initial chemotherapy.

+13 more

Exclusion Criteria

I cannot undergo surgery due to other health issues.

My cancer is at a stage where surgery might be possible.

I do not have any uncontrolled illnesses like infections or heart problems.

+6 more

Participant Groups

The study tests if high-dose radiation therapy combined with capecitabine (a chemotherapy drug) can make patients eligible for surgery and extend their lives compared to the standard treatment.

1Treatment groups

Experimental Treatment

Group I: HFA-IMRTExperimental Treatment2 Interventions

Eligible patients will receive HFA-IMRT to a total dose of 67.5 Gy in 15 fractions or 75Gy in 25 fractions to areas of gross tumor with concurrent capecitabine. Cross-sectional imaging will be repeated 4-6 weeks after the end of CRT to assess for resectability.

Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Xeloda for: