Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients
Randomized Trial of Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy to Patients With Early Low and Mid Rectal Cancer: The Watchful Waiting 3 Trial (WW3)
Vejle Hospital
162 participants
Jan 20, 2020
INTERVENTIONAL
Conditions
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 Criteria14
- 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 Criteria6
- 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
Interventions
Standard radiotherapy
Experimental radiotherapy
Standard chemotherapy
Locations(5)
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NCT04095299