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Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation

Exploring new drug Irinotecan with FOLFOX after radiation for rectal cancer.

Recruiting
18 years and older
All
Phase 2

Study on New Treatment for Advanced Rectal Cancer

This study is testing a new way to treat stage II-III rectal cancer, which is cancer found in the lower part of the large intestine. It compares the effects of two drug combinations after radiation therapy: FOLFOX (Leucovorin, Fluorouracil, and Oxaliplatin) and FOLFIRINOX (Leucovorin, Fluorouracil, Irinotecan, and Oxaliplatin). These drugs work together to stop cancer cells from growing or spreading. The aim is to see if FOLFIRINOX can improve the chance of avoiding surgery and keep the organs safe longer. Participants will have different tests like CT scans and MRIs, and provide blood and tissue samples throughout the study.

  • The study involves regular hospital visits for chemotherapy and tests.
  • Potential benefits include avoiding surgery and preserving organs.
  • Participants will need to be at least 18 years old and meet specific health requirements.

This study requires participants to be healthy enough for treatment, not pregnant, and willing to undergo several tests. It is important for interested individuals to consult with their doctor to see if they meet the criteria and understand the potential risks and benefits.

Study details
    Locally Advanced Rectal Carcinoma
    Stage II Rectal Cancer AJCC V8
    Stage III Rectal Cancer AJCC V8

NCT05610163

Alliance for Clinical Trials in Oncology

19 January 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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