NCT04664504

A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Jing Jin, M.D. · Unknown
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

Detailed description

For patients with locally advanced rectal cancer, radiotherapy and chemotherapy combined with surgery can improve the curative effect. Rectal magnetic resonance imaging (MRI) can be used to stratify the risk of locally advanced rectal cancer before treatment. In this study, we planned to use rectal MRI parameters and the possibility of patients with anal preservation to group, and to observe the R0 resection rate and disease-free survival rate of patients with stage II / III rectal cancer after individualized preoperative radiotherapy and chemotherapy combined with radical surgery.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Concurrent Chemoradiotherapy Radiotherapy	50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d.
RADIATION	Short-course Radiotherapy	25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
RADIATION	Local dose increase of Short-course Radiotherapy	25Gy in 5 fractions to the of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. And 4Gy in 1 fractions to the PGTV of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
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 4 cycles. 4 courses\*3 weeks per course.
DRUG	Adjuvant chemotherapy	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 6 cycles. 6 courses\*3 weeks per course
PROCEDURE	TME	Total mesorectal excision

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-12-01
• Completion: 2025-12-01
• First posted: 2020-12-11
• Last updated: 2021-06-08

Locations

1 site across 1 country: China