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

• Status: Recruiting
• Trial end date: 2028-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vejle Hospital
• Treatments: Capecitabine

Criteria

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