NCT06205485

Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation Versus Chemoradiotherapy For Early Rectal Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?

Detailed description

This study is being done to find out if this approach is better or worse than the usual approach for early rectal cancer. The usual approach is defined as care most people get for early rectal cancer. The usual approach for patients who are not in a study is surgery to remove the rectum or treatment with chemotherapy and radiation therapy, followed by surgery. There are several chemotherapy drugs approved by Health Canada that are commonly used with radiation therapy. For patients who get the usual approach for this cancer, about 90 out of 100 are free of cancer after 5 years. If a patient decides to take part in this study, they will either get a combination of chemotherapy drugs called FOLFOX or CAPOX for up to 12 weeks or will get chemotherapy with radiation therapy for up to 6 weeks. After finishing treatment, and even if treatment is stopped early, the study doctor will watch for side effects and determine which type of surgery would be best. After surgery, patients will be asked to come in every 4 months for 2 years, then every 6 months for an additional year. Then will be checked every year for 2 years. This means seeing the study doctor for up to 5 years after surgery. Patients may be seen more often if your study doctor thinks it is necessary.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Leucovorin	400 mg/m2
DRUG	Oxaliplatin	85 mg/m2 or 130 mg/m2 on day 1
DRUG	Fluoruracil	bolus fluoruracil (optional) 400 mg, infusional fluorouracil 2,400 mg/m2
DRUG	Capecitabine	1,000 mg/m2 twice daily for 14 days
RADIATION	Radiation	54 Gy (27-30 fractions)

Timeline

• Start date: 2024-06-26
• Primary completion: 2030-01-30
• Completion: 2030-06-30
• First posted: 2024-01-16
• Last updated: 2026-04-14

Locations

105 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study