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Chemotherapy vs Chemoradiotherapy for Rectal Cancer (NEO-RT Trial)

Phase 3
Recruiting
Research Sponsored by Canadian Cancer Trials Group
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 6 years
Awards & highlights

Summary

This trial aims to determine if giving chemotherapy alone before limited surgery is as effective as giving chemotherapy and radiation therapy together before surgery in treating rectal cancer. It also seeks to understand if quality of life is

Who is the study for?
This trial is for adults with mid to low-lying rectal cancer that's suitable for limited surgery, not spread elsewhere (M0), and without certain blood vessel involvement. Patients must be fit for major surgery, able to complete questionnaires in English, French or Spanish, and have no issues with the chemotherapy drugs planned.
What is being tested?
The study compares two pre-surgery treatments: one group receives only chemotherapy (Fluoruracil, Oxaliplatin, Leucovorin) while the other gets both chemo and radiation therapy followed by limited surgery. The goal is to see if avoiding radiation improves quality of life without affecting treatment response.
What are the potential side effects?
Chemotherapy may cause nausea, fatigue, mouth sores, low blood counts leading to infection risk or bleeding problems. Radiation can add skin irritation at the treated site and bowel symptoms like diarrhea. Side effects vary based on individual health conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Disease Free Survival
Total Mesorectal Excision (TME) Free Survival

Trial Design

2Treatment groups
Active Control
Group I: FOLFOX OR CAPOXActive Control4 Interventions
FOLFOX= Six cycles of modified FOLFOX consisting of leucovorin, oxaliplatin and bolus fluoruracil (optional), infusional fluorouracil. CAPOX= Capecitabine twice daily for 14 days and Oxaliplatin on day 1
Group II: ChemoRTActive Control3 Interventions
Standard dose of infusional 5-Fluorouracil/capecitabine and radiation

Find a Location

Who is running the clinical trial?

NRG OncologyOTHER
236 Previous Clinical Trials
102,025 Total Patients Enrolled
Canadian Cancer Trials GroupLead Sponsor
127 Previous Clinical Trials
68,024 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupNETWORK
119 Previous Clinical Trials
178,797 Total Patients Enrolled
~167 spots leftby Jan 2030
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