Study on Preoperative ChemoRadiation and FOLFOXIRI for Rectal Cancer (CRAFTER)

Sponsor: Rutgers, The State University of New Jersey

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05358704

Provider View

This clinical trial is testing a combination of chemotherapy and radiation therapy before surgery to see if it can improve treatment outcomes for patients with rectal cancer. Participants will receive a mix of drugs and radiation, followed by surgery, and will be monitored for several years.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a treatment plan that combines chemotherapy and radiation therapy before surgery for rectal cancer. Participants will undergo various medical tests to confirm eligibility, receive the experimental treatment, and have regular follow-ups for up to four years. The study involves taking chemotherapy drugs (capecitabine, oxaliplatin, leucovorin, irinotecan, and fluorouracil) and radiation therapy before surgery, with regular check-ups to monitor health and treatment progress.

Description

Participants in this study will receive a combination of chemotherapy and radiation therapy for 28 days, followed by eight cycles of chemotherapy over 16 weeks before undergoing surgery. Each cycle lasts 14 days. If participants experience severe side effects but still benefit from the treatment, they may continue with the therapy under the investigator's guidance.

After stopping the study treatment, participants will have follow-up assessments about 30 and 90 days later. They will then enter a survival follow-up period, with check-ups every three months for up to three years, to monitor their health and survival.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Be able to provide written consent to participate.
  • Be fully active or able to do light work.
  • Have a confirmed diagnosis of rectal adenocarcinoma, located up to 15 cm from the anal verge.
  • Cancer must be at stage T3 or T4, N0-N2, and M0.
  • Have recent imaging tests to confirm no distant cancer spread.
  • Have adequate bone marrow, kidney, and liver function.
  • No active second cancers.
  • Be willing to follow all study procedures.
  • Women of childbearing potential must have a negative pregnancy test and agree to use two birth control methods or be surgically sterile.
  • Men must agree to use contraception or abstain from sex during the study and for 120 days after the last treatment.
  • Have a Zubrod Performance Status of 0-2.
  • Have adequate blood counts and organ function as determined by specific tests.
  • If HIV positive, have a CD4 count of at least 200 cells/μL, be on stable antiretroviral therapy, and have no opportunistic infections.

Exclusion Criteria

  • Under 18 years old.
  • Pregnant or breastfeeding.
  • Have had another invasive cancer within the last three years, except for certain skin cancers.
  • Have had chemotherapy for colorectal cancer before.
  • Have had radiation therapy that overlaps with the study treatment area.
  • Have severe, active health conditions like recent heart problems or infections.
  • Have uncontrolled seizures or psychiatric conditions.
  • Have grade two or higher peripheral neuropathy.
  • Have had major surgery within 28 days before joining the study.
  • Have had allergic reactions to oxaliplatin or capecitabine.
  • Have distant cancer spread or another primary colon cancer.
  • Have severe digestive issues that affect drug absorption.
  • Have participated in another drug study within 28 days before joining this study.

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