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

NCT04095299 · tracked via the Priya Life Science Denmark tracker

Sponsor

Vejle Hospital

Phase

Phase 3

Started

2020-01-20

Last updated

2026-01-08

Condition(s) studied

Cancer of Rectum

Investigational drug(s) / intervention(s)

50.4 Gy to the tumor and elective volume62 Gy to the clinical tumor volume and 50.4 Gy to the elective volumeCapecitabine 825 mg/m2 twice daily on weekdays

50.4 Gy to the tumor and elective volume: Standard radiotherapy

62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume: Experimental radiotherapy

Capecitabine 825 mg/m2 twice daily on weekdays: Standard chemotherapy

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Histopathologically verified adenocarcinoma of the rectum * MDT conference finds patient a candidate for rectal resection * Clinical tumor category cT1-3 * MRI findings * Maximal cross-sectional size of 4.5 cm (axial plane relative to the rectum) * Lowest edge of tumor located at or below the peritoneal reflection on MRI * Performance status 0-2 * Age ≥ 18 years * Eligible for radiotherapy and capecitabine according to investigator, including * Adequate function of bone marrow (neutrophils ≥ 1.5 x 10\^9/l and thrombocytes ≥ 100 x 10\^9/l) * Adequate function of liver (ALAT \< 2.5 x upper limit of normal, bilirubin \< 2.5 x upper limit of normal) * Adequate kidney function (Serum creatinine \< 1.5 x upper limit of normal or measured GFR \> 30 ml/min) * Fertile women must present a negative pregnancy test and use secure contraceptives during and three months after treatment * Written and orally informed consent Exclusion Criteria: * Previous surgical treatment of the present cancer, including transanal excision of tumor * Other malignant disease within the past five years except non-melanoma skin cancer and premalignant lesions such as carcinoma in situ * Distant metastases verified by imaging or biopsy, i.e. cM1 * Previous radiation treatment of the pelvis * Pregnant or breastfeeding women. * Existing colostomy or ileostomy

Primary outcome measure(s)

Rectal preservation at two years — 2 years after start of treatment
* Presence of a full-length rectum, i.e. no rectal resection. * Absence of rectal tumor, malignant lymph nodes or any other tumor deposit or recurrence within the pelvis based on clinical examination, CT and MR * No stoma because of side effects to treatment or rectal dysfunction

Trial sites (5)

Facility	City	Region	Status
Aalborg University Hospital	Aalborg	Denmark	Recruiting
Copenhagen University Hospital, Righshospitalet and Bispebjerg Hospital	Copenhagen	Denmark	Recruiting
Zealand University Hospital, Næstved	Næstved	Denmark	Recruiting
Zealand University Hospital, Roskilde	Roskilde	Denmark	Recruiting
Department of Oncology, Vejle Hospital	Vejle	Denmark	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04095299 on ClinicalTrials.gov ↗ ← All trials in Denmark