Status:
RECRUITING
Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients
Lead Sponsor:
Vejle Hospital
Conditions:
Cancer of Rectum
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 res...
Detailed Description
The main curative treatment modality for rectal cancer is surgery, potentially combined with chemotherapy and radiotherapy to lower the risk of local recurrence. In recent years, an increasing number ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2033
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT04095299
Start Date
January 20 2020
End Date
December 1 2033
Last Update
January 8 2026
Active Locations (5)
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1
Aalborg University Hospital
Aalborg, Denmark
2
Copenhagen University Hospital, Righshospitalet and Bispebjerg Hospital
Copenhagen, Denmark
3
Zealand University Hospital, Næstved
Næstved, Denmark
4
Zealand University Hospital, Roskilde
Roskilde, Denmark