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

Launched by VEJLE HOSPITAL · Sep 17, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether a higher dose of radiotherapy is more effective than a standard dose for patients with early rectal cancer who are receiving chemotherapy and radiotherapy. The goal is to see if patients can achieve a complete response to treatment, potentially allowing them to avoid surgery and preserve their rectum. This research builds on previous studies that showed promising results in preserving the rectum in similar cases.

To participate in this trial, patients need to have a confirmed diagnosis of rectal cancer and be considered candidates for surgery. They should be between 18 years and older and have specific health criteria, including good functioning of their bone marrow, liver, and kidneys. Participants will receive treatment and will be monitored throughout the process. Importantly, women who can become pregnant must use effective birth control during and for three months after treatment. Overall, this trial aims to help improve treatment options for rectal cancer while minimizing the need for surgery.

Gender

ALL

Eligibility criteria

• 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