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Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

NCT06205485 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-12

No results posted yet for this study

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?

Conditions

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Hagen Kennecke · Providence Portland Medical Centre, Portland, OR, USA

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-26
Primary Completion
2030-01-30
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT06205485 on ClinicalTrials.gov