What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as the Preoperative ChemoRadiation and FOLFOXIRI regimen, have several known side effects. Capecitabine can cause hand-foot syndrome, diarrhea, nausea, vomiting, and fatigue. Radiation therapy may lead to skin irritation, fatigue, and gastrointestinal issues like diarrhea and rectal bleeding. Oxaliplatin is known for causing peripheral neuropathy, nausea, and increased risk of infection. Leucovorin can cause mild side effects like rash and diarrhea. Irinotecan is associated with severe diarrhea and neutropenia. Fluorouracil can cause mucositis, diarrhea, and myelosuppression. Combining these treatments can amplify these side effects, necessitating comprehensive management.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer that are similar to those studied in the Preoperative ChemoRadiation and FOLFOXIRI trial. Capecitabine, an oral prodrug of fluorouracil, is approved for use in combination with radiation therapy to induce DNA damage and inhibit cell division. The FOLFOX regimen, which includes oxaliplatin, leucovorin, and fluorouracil, is approved for its ability to inhibit DNA synthesis and repair, leading to cancer cell death. Irinotecan, another component of the FOLFOXIRI regimen, is also FDA-approved for colorectal cancer treatment due to its role in inhibiting topoisomerase I, an enzyme crucial for DNA replication. These treatments collectively target cancer cells by disrupting their DNA and inhibiting their ability to divide and repair.

What other types of research exist?

Promising novel alternatives for colorectal cancer treatment in 2024 include: 1) Immunotherapy combinations such as PD-1 inhibitors (e.g., pembrolizumab) with CTLA-4 inhibitors (e.g., ipilimumab) for microsatellite instability-high (MSI-H) tumors. 2) Targeted therapies like BRAF inhibitors (e.g., encorafenib) combined with EGFR inhibitors (e.g., cetuximab) for BRAF V600E-mutant tumors. 3) Novel chemotherapy regimens incorporating agents like trifluridine/tipiracil (TAS-102) with bevacizumab. 4) Personalized medicine approaches using next-generation sequencing to tailor treatments based on specific genetic mutations and biomarkers.

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Chemotherapy

Preoperative Chemoradiation + FOLFOXIRI for Rectal Cancer

Phase 2

Recruiting

Led By Salma Jabbour, 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

No Placebo-Only Group

Summary

This trial uses a combination of chemotherapy and radiation therapy before surgery for patients with rectal cancer. The goal is to improve their response to treatment by killing cancer cells and shrinking tumors. The trial uses UFT and leucovorin, which have shown encouraging preliminary results as an alternative to the conventional 5-FU in preoperative chemoradiation for rectal cancer.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Positron emission tomography (PET)

Secondary study objectives

Magnetic resonance imaging (MRI)

Other study objectives

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)

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: 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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer, such as those in the Preoperative ChemoRadiation and FOLFOXIRI trial, work by targeting cancer cell DNA and inhibiting cell division. Capecitabine, an oral prodrug of 5-fluorouracil (5-FU), and radiation therapy both induce DNA damage, leading to cell death. Oxaliplatin forms platinum-DNA adducts, disrupting DNA replication and transcription. Leucovorin enhances the binding of 5-FU to the enzyme thymidylate synthase, increasing its efficacy. Irinotecan inhibits topoisomerase I, preventing DNA unwinding and replication. These mechanisms are crucial for colorectal cancer patients as they directly target the rapidly dividing cancer cells, aiming to reduce tumor size and prevent metastasis.

Combination chemotherapy versus single-agent chemotherapy during preoperative chemoradiation for resectable rectal cancer.A Phase I study of weekly intravenous oxaliplatin in combination with oral daily capecitabine and radiation therapy in the neoadjuvant treatment of rectal adenocarcinoma.