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

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

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

Conditions2

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