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Chemotherapy
Preoperative Chemoradiation + FOLFOXIRI for Rectal Cancer
Phase 2
Recruiting
Led By Patrick M Boland, MD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat rectal cancer. Eligible participants will receive the experimental drugs prior to surgery and will be followed for 3-4 years after the study.
Who is the study for?
Adults over 18 with stage T3 or T4 rectal cancer without distant metastases, good organ function, and no severe comorbidities. They must not have had previous chemotherapy for colorectal cancer, be free from other active cancers for three years, and not have certain infections or uncontrolled diseases. Women of childbearing potential need a negative pregnancy test and agree to contraception; men also need to use contraception.Check my eligibility
What is being tested?
The trial tests preoperative chemoradiation combined with FOLFOXIRI (a mix of Oxaliplatin, leucovorin, irinotecan, fluorouracil) in rectal cancer patients. Participants will receive this treatment before surgery to assess safety and effectiveness in increasing complete response rates.See study design
What are the potential side effects?
Possible side effects include reactions related to the infusion process, fatigue, digestive issues like nausea or diarrhea due to chemotherapy drugs involved. There's also a risk of blood cell count changes leading to increased infection risk or bleeding problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ four years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Positron emission tomography (PET)
Secondary outcome measures
Magnetic resonance imaging (MRI)
Other outcome measures
Cognitive Therapy
Computed tomography (CT) Scan of Chest, Abdomen and Pelvis (CT C/A/P)
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Combination of drugs prior to surgeryExperimental Treatment1 Intervention
Receive the experimental combination of drugs (chemoradiation (capecitabine and radiation) + FOLFOXIRI (Oxaliplatin, leucovorin, irinotecan, and fluorouracil) prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three to four years. The time in the study will take approximately four - six hours during pre-study, study and end of study visits.
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Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
430 Previous Clinical Trials
64,620 Total Patients Enrolled
Patrick M Boland, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
Salma Jabbour, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
4 Previous Clinical Trials
105 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Combination of drugs prior to surgery
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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