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NEO: Neoadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer

NCT03259035 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-04-09

Study results available
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Summary

The purpose of this study is to find out the effects of chemotherapy followed by less invasive surgery on patients and their early rectal cancer. The approach of this trial will be considered a success if at least 65% of participants are able to keep the rectum.

Conditions

Interventions

DRUG

Folfox Protocol

6 cycles of q2weekly FOLFOX, or

DRUG

Capox

4 cycles of q3weekly CAPOX

Sponsors & Collaborators

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Hagen Kennecke · Virginia Mason Medical Centre, WA USA

  • Carl Brown · St. Paul's Hospital, Vancouver BC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-29
Primary Completion
2024-04-08
Completion
2024-04-25
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03259035 on ClinicalTrials.gov