Comparing standard and high doses of radiotherapy for rectal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether a higher dose of radiotherapy is more effective than a standard dose in patients with early rectal cancer who are receiving chemoradiotherapy. The research aims to determine if patients can avoid surgery by achieving a complete response to treatment. It focuses on patients with histopathologically verified adenocarcinoma of the rectum and evaluates their response to different radiation doses combined with chemotherapy. The study is designed to provide high-level evidence regarding the optimal radiotherapy dose for non-surgical management of early-stage rectal cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Principal investigator: Lars H Jensen, MD, PhD — Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark
• Study coordinator: Lars H Jensen, MD, PhD
• Email: lars.henrik.jensen@rsyd.dk
• Phone: +45 7940 6802

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.