NCT04134897

Neoadjuvant Chemotherapy in Patients With Moderate Risk Mid Rectal Cancer

A Multicenter Prospective Phase III Clinical Trial of Neoadjuvant CapOx in Patients With Intermediate Risk CRM-negative Middle Rectal Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 316 (estimated)
• Sponsor: Blokhin's Russian Cancer Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether 3 months of neoadjuvant CapOx is non-inferior to neoadjuvant radiotherapy in patients with moderate risk CRM"-" mid rectal cancer.

Detailed description

This trial aims to investigate the efficacy of neoadjuvant chemotherapy compared to 5x5 Gy neoadjuvant radiotherapy in moderate risk CRM-negative rectal cancer patients. This is a prospective multicenter open-label non-inferiority randomized phase III clinical trial. Patients will be randomized using an online randomization system to receive either 4 cycles of neoadjuvant CapOx (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 per os bid days 1-14) chemotherapy, surgery and 4 cycles of adjuvant CapOx chemotherapy or 5x5 Gy radiotherapy, surgery and 8 cycles of adjuvant CapOx chemotherapy. A stratification will be performed based on сN stage and clinical center. Patients with сT3c-T3dN0-1M0, cT1-T3dN2M0 cancer in the middle rectum are included. Chemoradiotherapy (50 Gy with concomitant capecitabine 825 mg/m2 per os bid on radiation days) will be performed for patients with tumor progression after neoadjuvant chemotherapy. The main hypothesis is that the 2-year local recurrence rate is non-inferior after neoadjuvant chemotherapy and neoadjuvant radiotherapy in moderate risk mid rectal cancer patients. The target accrual is 158 patients in each treatment arm (including 10% potential data loss) based on non-recurrence rate of 98% in investigated and 96% in the control group with a non-inferiority margin of 3%, α=0,05, power 80%. An interim analysis is planned after 50% of the patients will reach a 2-year followup. Pelvic Magnetic Resonance Imaging (MRI) is performed in all patients for staging before and after neoadjuvant chemotherapy and before surgery. Pelvic MRI is subject to central review. Conduction of this study and data collection are controlled by a local institutional board.

Conditions

• Rectal Neoplasms Malignant
• Rectum Carcinoma
• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	2000 mg/m2, bid, per os, days 1-14, 4 cycles
DRUG	Oxaliplatin	130 mg/m2 iv day 1, 4 cycles
DRUG	Capecitabine	825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
RADIATION	Radiotherapy	Pelvic radiotherapy dose: 44 Gy on regional nodes, 50 Gy on primary tumor
PROCEDURE	Rectal cancer surgery	Laparoscopic or open total mesorectal excision
RADIATION	Radiotherapy	Pelvic radiotherapy dose: 25 Gy in 5 Gy fractions

Timeline

• Start date: 2019-10-14
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2019-10-22
• Last updated: 2021-02-09

Locations

1 site across 1 country: Russia