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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

Pivotal Trial

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Disease Free Survival

Total Mesorectal Excision (TME) Free Survival

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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