This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.
In this randomized, controlled, parallel study we will comparison total neoadjuvant therapy with standard neoadjuvant therapy in rectal cancer treatment. Complete pathological response rate will be the primary endpoint in patients, who will undergoing surgery. In cases of complete clinical response we will provide "watch and wait" approach. Compliance of treatment and oncologic results will be the second endpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d
Total mesorectal excision
Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 3 courses, 3 weeks per course
State Scientific Centre of Coloproctology
Moscow, Russia
RECRUITINGThe rate of complete responses
The rate of pathological or clinical complete responses
Time frame: 3-6 months
Rate of R0-resections
Rate of R0-resections
Time frame: immediately after surgery
Rate of compliance with radiotherapy and chemotherapy
Rate of complications III-VI grade of radiotherapy (RTOG) and chemotherapy (NCI-CTC)
Time frame: 6-8 months
rate of intraoperative and postoperative complications
Frequency and structure of intraoperative and postoperative complications according to the Clavien-Dindo classification
Time frame: 0-30 days after surgery
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Administration of l-LV (400 mg/m2) and oxaliplatin (85 mg/ m2) by intravenous infusion over 2 h, followed by rapid intravenous infusion (iv) of 5-FU (400 mg/m2) and then slow infusion (civ) of 5-FU (2400 mg/m2 over 46 h), is repeated every 2 weeks for 6-12 cycles