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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and four 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

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,194 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

Media Library

Combination of drugs (chemoradiation (capecitabine and radiation) + FOLFOXIRI (Oxaliplatin, leucovorin, irinotecan, and fluorouracil)) (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05358704 — Phase 2

Colorectal Cancer Research Study Groups: Combination of drugs prior to surgery

Colorectal Cancer Clinical Trial 2023: Combination of drugs (chemoradiation (capecitabine and radiation) + FOLFOXIRI (Oxaliplatin, leucovorin, irinotecan, and fluorouracil)) Highlights & Side Effects. Trial Name: NCT05358704 — Phase 2

Frequently Asked Questions

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

At how many different sites is this trial currently being conducted?

"Enrollment for this trial is open at 5 sites, with the locations being in Livingston, Somerset and Toms River. There are also 5 other centres where patients can enroll. To make participation more convenient, please choose the location that is closest to you."

Answered by AI

How many people are being taken into this clinical trial?

"From what is published on clinicaltrials.gov, it seems that the team conducting this trial are actively recruiting patients. The study was first advertised on 05/13/2022 and has since been updated 11/02/2022. They need a total of 38 individuals between 5 different locations."

Answered by AI

Are patients still being accepted for this clinical trial?

"The answer is affirmative. The clinicaltrials.gov website contains information specifying that this research project is actively recruiting participants. This trial was originally posted on May 13th, 2022 and has undergone its most recent update on November 2nd of the same year. The study requires 38 individuals who can visit one of five different sites."

Answered by AI

Are the drugs capecitabine, radiation, oxaliplatin, leucovorin, irinotecan, and fluorouracil all approved by the FDA to be used together?

"Chemoradiation (capecitabine and radiation) + FOLFOXIRI (Oxaliplatin, leucovorin, irinotecan, and fluorouracil) is a Phase 2 trial drug combination. While there is some evidence backing its safety, more needs to be gathered on the efficacy of this potential treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preoperative ChemoRadiation And FOLFOXIRI for Rectal Cancer (CRAFTER) for Rectal Cancer

Salma Jabbour, MD 2022. "Preoperative ChemoRadiation And FOLFOXIRI for Rectal Cancer (CRAFTER) for Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05358704.