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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

MAIBE Trial 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.Check my eligibility
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.See study design
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.

MAIBE Trial 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 completed 3 months of initial chemotherapy for pancreatic cancer within the last 6 weeks.
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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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I haven't taken any experimental drugs for at least 2 weeks or 5 half-lives before starting radiation therapy.
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Any side effects from my previous treatments are mild.
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I am 18 years old or older.
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My organs and bone marrow are functioning well.

MAIBE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of patients who undergo definitive surgery

MAIBE 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
1,928 Previous Clinical Trials
591,761 Total Patients Enrolled
Marsha ReyngoldPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03523312 — Phase 2
Pancreatic Cancer Research Study Groups: HFA-IMRT
Pancreatic Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT03523312 — Phase 2
Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03523312 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment opportunities still available for this research endeavor?

"The clinicaltrials.gov website confirms that this trial has ceased recruitment at the moment; it was initially disclosed on April 30th 2018 and last modified on May 4th 2022. However, there are presently 1033 other trials actively looking for eligible patients."

Answered by AI

What therapeutic applications is capecitabine commonly utilized for?

"Capecitabine is known to be effective in treating malignant neoplasms. It can also prove beneficial for patients with pancreatic endocrine carcinoma, colorectal carcinoma and those suffering from refractory ovarian cancer."

Answered by AI

How has capecitabine been explored in previous research?

"According to the current statistics, 334 clinical trials are already underway for capecitabine. Of those experiments, 126 of them have progressed to Phase 3. Woolloongabba in Queensland is hosting the majority of these studies; however 12828 other sites worldwide are also taking part in this research endeavour."

Answered by AI

Has the FDA granted approval for capecitabine as a therapeutic agent?

"Considering the Phase 2 nature of this trial, Power's evaluation yielded a safety score of 2 for capecitabine due to the lack of evidence concerning its efficacy."

Answered by AI

Are Canadian medical facilities presently conducting this clinical research?

"Currently, 8 clinical sites are looking to enroll patients in this medical trial. These include Memorial Sloan Kettering Westchester of Harrison, Memorial Sloan Kettering Bergen based in Montvale, and further centers such as the one located at Rockville Centre. Additionally, there are 5 other locations also participating."

Answered by AI

What is the participant recruitment target for this research trial?

"This trial is no longer accepting new patients as it was last updated on May 4th, 2022. However, there are 699 alternative studies onboarding individuals with pancreatic cancer and 334 trials utilizing capecitabine actively looking for recruits."

Answered by AI
~0 spots leftby Apr 2024