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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 belowSelect...
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:Select...
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
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
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,964 Previous Clinical Trials
596,904 Total Patients Enrolled
Marsha ReyngoldPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your platelet count is higher than 75,000 per microliter.I cannot undergo surgery due to other health issues.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.My cancer is at a stage where surgery might be possible.I do not have any uncontrolled illnesses like infections or heart problems.I have had radiation therapy to my abdomen before.I completed 3 months of initial chemotherapy for pancreatic cancer within the last 6 weeks.Your white blood cell count is higher than 3,000 per microliter.Women who can have babies need to have a negative pregnancy test within 14 days before starting the study treatment.I cannot have iodine contrast due to health reasons.I am mostly able to care for myself and carry out daily activities.Your body has enough infection-fighting white blood cells.Your bilirubin levels are not more than two times the normal limit.My kidney function, measured by creatinine levels, is within the normal range.I am using birth control and will continue for the study duration and 4 weeks after.I agree to use effective birth control during the study.My pancreatic cancer is advanced and cannot be surgically removed due to its spread.I haven't taken any experimental drugs for at least 2 weeks or 5 half-lives before starting radiation therapy.Any side effects from my previous treatments are mild.I am 18 years old or older.Your liver enzymes (AST and ALT) are not too high.My organs and bone marrow are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: HFA-IMRT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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