Study on Chemotherapy, Surgery, and Observation vs. Chemoradiotherapy for Rectal Cancer

Sponsor: Canadian Cancer Trials Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06205485

Provider View

This clinical trial is exploring whether chemotherapy alone before surgery is as effective as chemotherapy combined with radiation before surgery for rectal cancer. It also examines if skipping radiation improves quality of life.

Patient Parameters

Program Overview

The study aims to determine if using chemotherapy alone before surgery is better or worse than the usual treatment for early rectal cancer, which typically involves surgery or a combination of chemotherapy and radiation followed by surgery. The usual treatment helps about 90 out of 100 patients remain cancer-free for 5 years. Participants in this study will receive either chemotherapy alone (FOLFOX or CAPOX) for up to 12 weeks or chemotherapy with radiation for up to 6 weeks. After treatment, doctors will monitor for side effects and decide on the best surgical approach. Follow-up visits will occur every 4 months for 2 years, then every 6 months for another year, and annually for 2 more years, totaling up to 5 years of follow-up.

Description

This study is investigating whether chemotherapy alone before surgery is as effective as the usual treatment for early rectal cancer, which involves surgery or chemotherapy and radiation followed by surgery. The usual treatment helps about 90 out of 100 patients remain cancer-free for 5 years. Participants will receive either chemotherapy alone (FOLFOX or CAPOX) for up to 12 weeks or chemotherapy with radiation for up to 6 weeks. After treatment, doctors will monitor for side effects and decide on the best surgical approach. Follow-up visits will occur every 4 months for 2 years, then every 6 months for another year, and annually for 2 more years, totaling up to 5 years of follow-up.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of invasive, well to moderately differentiated rectal adenocarcinoma.
  • Tumor stage cT1 not eligible for transanal surgery or cT2, with no lymph node involvement or metastasis.
  • Tumor located in the mid to lower rectum, suitable for transanal excision.
  • Medically fit for major surgery as determined by the surgeon.
  • Able to complete quality of life questionnaires in English, French, or Spanish.
  • At least 18 years old.
  • No contraindications to the chemotherapy used in the study.
  • Normal organ and bone marrow function, with specific blood count and kidney function levels.
  • ECOG performance status less than 2.
  • Must be available for treatment and follow-up.
  • Women and men of childbearing potential must use effective contraception during and for 6 months after chemotherapy.
  • HIV-positive patients on effective treatment with undetectable viral load are eligible.

Exclusion Criteria

  • High-risk factors found in initial biopsy, such as poorly differentiated tumors or specific types of cancer cells.
  • Visible pelvic sidewall lymph nodes on MRI.
  • Clear evidence of lymph node disease that would prevent study treatment.
  • Previous pelvic radiation therapy.
  • Prior removal of the primary tumor before joining the study.
  • Previous or current cancer that could interfere with the study treatment.
  • Prior treatment for rectal cancer.
  • Known deficiency in the enzyme dihydropyrimidine dehydrogenase (DYPD).
  • Must have recovered from significant side effects of recent treatments before joining the study.
  • History or symptoms of heart disease, or previous treatment with heart-damaging drugs, must be assessed for heart function.
  • Any issues preventing MRI imaging.
  • Tumors located in areas that make transanal excision impossible.

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