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

RecruitingPhase 3Ages 18 Years - anyAllVejle Hospital
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • 50.4 Gy to the tumor and elective volume
  • 62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume
  • Capecitabine 825 mg/m2 twice daily on weekdays
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Where

5 sites
Aalborg University Hospital
Aalborg, Denmark
Copenhagen University Hospital, Righshospitalet and Bispebjerg Hospital
Copenhagen, Denmark
Zealand University Hospital, Næstved
Næstved, Denmark
Zealand University Hospital, Roskilde
Roskilde, Denmark
Department of Oncology, Vejle Hospital
Vejle, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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