MedTrace Logo

Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients

NCT04095299 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2026-01-08

No results posted yet for this study

Summary

In recent years, an increasing number of retrospective and prospective observational studies have indicated that a subset of rectal cancer patients may avoid surgery if they can achieve a complete response to chemoradiotherapy. Prospective trials, including the previous Danish Watchful Waiting trials (NCT00952926, NCT02438839) in early rectal cancer have demonstrated high levels of organ preservation with dose-escalation, but it is unclear whether this was primarily due to tumor stage or dose level.

The aim of the present study is to investigate if a higher dose of radiotherapy is superior compared to a standard dose in patients with early rectal cancer undergoing chemoradiotherapy with curative intent.

Conditions

  • Cancer of Rectum

Interventions

RADIATION

50.4 Gy to the tumor and elective volume

Standard radiotherapy

RADIATION

62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume

Experimental radiotherapy

DRUG

Capecitabine 825 mg/m2 twice daily on weekdays

Standard chemotherapy

Sponsors & Collaborators

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Lars H Jensen, MD, PhD · Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2026-12-31
Completion
2033-12-31

Countries

  • Denmark

Study Locations

More Related Trials

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 NCT04095299 on ClinicalTrials.gov