NCT02941562

A Prospective Phase II Randomized Clinical Trial of Preoperative Chemotherapy Combined With Short-course Radiotherapy Versus Conventional Neo-adjuvant Therapy for Locally Advanced Rectal Cancer Implemented by MDT

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy in a prospective cohort and to correlate this response with patient's outcome

Detailed description

This is a phase II , open label, randomized study in patients with confirmed diagnosis of locally advanced rectal cancer. The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy.

Conditions

• Rectal Cancer, Radiotherapy

Interventions

Type	Name	Description
RADIATION	Short-course radiotherapy	Preoperative Radiation doses: 25 Gy in 5 fractions to the pelvis
DRUG	FOLFOX4 chemotherapy,preoperative	FOLFOX4 chemotherapy：5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1. Repeat every 2 weeks
RADIATION	Radiotherapy of neo-adjuvant therapy	Preoperative Radiation doses: 45 Gy in 25 fractions to the pelvis, 5.4 Gy in 3 fractions to the pelvis
DRUG	Concurrent chemotherapy of neo-adjuvant therapy	Capecitabine 825mg/m2 twice daily 5 days/week
PROCEDURE	Radical rectal cancer resection	Radical rectal cancer resection
DRUG	FOLFOX4 chemotherapy,post-operative	FOLFOX4 chemotherapy：5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1. Repeat every 2 weeks

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-12-01
• First posted: 2016-10-21
• Last updated: 2016-10-24