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High-Dose Radiation + Chemotherapy for Pancreatic Cancer (MAIBE Trial)
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.
MAIBE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMAIBE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MAIBE Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: HFA-IMRT
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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