400
Participants
Start Date
January 7, 2025
Primary Completion Date
December 27, 2029
Study Completion Date
December 27, 2029
Radiation Therapy
Radiation therapy (RT) is administered at a dose of 2 Gy per day for a total dose of 50 Gy delivered to the pelvis. This is done throughout 5 to 6 weeks.
Chemoradiotherapy
"Capecitabine: 825 mg/m² twice daily, prescribed 1-5 days per week, for 5 weeks during RT.~Or Bolus 5-FU regimen: 5-fluorouracil (5-FU) 400 mg/m2/day intravenously, administered on days 1-4 and 33-35. Calcium folinate (folinic acid) 20 mg/m2/day intravenously on days 1-4 and 33-35."
Consolidation Chemotherapy
"XELOX: Oxaliplatin 130 mg/m² (day 1) + capecitabine 1000 mg/m² (days 1-14), every 3 weeks for 4 cycles.~Or FOLFOX: Oxaliplatin - 85 mg/m2 intravenously (2-hour infusion), drip for 1 day. Calcium folinate (folinic acid) - 400 mg/m2/d. intravenously (2-hour infusion), started on day 1. F(5-fluorouracil) - 400 mg/m2/d. intravenously (bolus), started on day 1. Repeat every 2 weeks for 6 times."
Surgery
Transabdominal Resection: Abdominoperineal resection, low anterior resection, or coloanal anastomosis using total mesorectal excision.
Part two
Standard treatment protocols and follow-up procedures are implemented in clinical practice.
Adjuvant treatment
If indicated, adjuvant therapy will be administered as usual in clinical practice.
RECRUITING
Nacional Cancer Institute, Vilnius
Vilnius University
OTHER
Tomas Poskus, Faculty of Medicine, Vilnius University
UNKNOWN
Vilnius University Hospital Santaros Klinikos
OTHER
Research Council of Lithuania
OTHER
National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
OTHER