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Anti-metabolites

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

Phase 2

Waitlist Available

Led By Marsha Reyngold

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytopathologically confirmed adenocarcinoma of the pancreas

No evidence of distant metastasis either prior to or after induction chemotherapy

Must not have

Patients who are not surgical candidates due to medical co-morbidities

Patients who have borderline resectable disease using NCCN definition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if higher than standard doses of radiation, with chemotherapy, can make patients more eligible for surgery and improve survival rates.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include fatigue, skin reactions from radiation, nausea, diarrhea from capecitabine, low blood counts increasing infection risk, and possible liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am mostly able to care for myself and carry out daily activities.

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My kidney function, measured by creatinine levels, is within the normal range.

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My pancreatic cancer is advanced and cannot be surgically removed due to its spread.

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Any side effects from my previous treatments are mild.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo surgery due to other health issues.

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

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

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I have had radiation therapy to my abdomen before.

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I cannot have iodine contrast due to health reasons.

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I am using birth control and will continue for the study duration and 4 weeks after.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The proportion of patients who undergo definitive surgery

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

capecitabine

2002

Completed Phase 3

~2360

0 / 13Eligibility criteria met