NCT05939661

A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer

A Multicenter Single-arm Phase 2 Study to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy of Short Course Radiation Therapy Followed by Neoadjuvant Oxaliplatin/Fluorouracil-based Chemotherapy (CAPOX) for cT2 Rectal Cancer.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Osaka University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicenter single-arm phase 2 study to evaluate safety and efficacy of the total neoadjuvant therapy of short course radiation therapy followed by neoadjuvant oxaliplatin/fluorouracil-based chemotherapy (CAPOX) for cT2 rectal cancer

Detailed description

To evaluate the efficacy and safety of preoperative radiation therapy followed by preoperative chemotherapy and surgery for T2 advanced rectal cancer.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Radiation	Neoadjuvant radiation therapy : 5Gyx5
DRUG	Chemotherapy	CAPOX (Oxaliplatin 130mg/m2, Capecitabine2000mg/m2/day, d1-14, 3week)x6cycles
PROCEDURE	Surgery	Operation: Total methorectum excision wiht radical lymph node dissection

Timeline

• Start date: 2023-05-25
• Primary completion: 2026-03-31
• Completion: 2030-03-31
• First posted: 2023-07-11
• Last updated: 2023-07-11

Locations

2 sites across 1 country: Japan