NCT04747951

Total Neoadjuvant Therapy in Rectal Cancer Treatment

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: State Scientific Centre of Coloproctology, Russian Federation · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.

Detailed description

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.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Concurrent Chemoradiotherapy	50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d
PROCEDURE	TME	Total mesorectal excision
DRUG	consolidation chemotherapy	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
DRUG	adjuvant chemotherapy	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

Timeline

• Start date: 2020-10-30
• Primary completion: 2023-10-30
• Completion: 2023-11-01
• First posted: 2021-02-10
• Last updated: 2021-02-15

Locations

1 site across 1 country: Russia

Regulatory

• FDA-regulated drug study