A Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer

Phase 2

• Conditions: Rectal Cancer
• Interventions: Drug: Oxaliplatin; Drug: Capecitabine; Radiation: Radiotherapy; Procedure: Surgery

• Registration Number: NCT01064999
• Lead Sponsor: Fudan University

Brief Summary

Neoadjuvant chemoradiotherapy (CRT) has been the standard therapy for local advanced rectal cancer. Pathological complete response (pCR) is an important prognostic factor for local control and survival. A high intensity CRT increases not only the pCR rate, but also toxicity, especially diarrhea. Compared with traditional RT technique, intensity-modified radiation therapy (IMRT) can decrease the toxicity of diarrhea because of low volume of high dose for small bowel. Therefore, IMRT technique provides an opportunity to improve the dose intensity of neoadjuvant CRT. The investigators hypothesize that a higher treatment dose induces a high rate of pCR and design a two-arm trial. in this trial, low intensity CRT includes the whole pelvic irradiation of 50Gy together with Oxaliplatin and Capecitabine weekly. While in high intensity group, additional concomitant 5Gy for primary tumor and a cycle of Xelox are prescribed. All patients will receive a total mesorectal excision (TME) 8 weeks after CRT.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Study Start: 2010-03
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Last Update Submitted: 2012-03-12
• Last Update Posted: 2012-03-14
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Patients with rectal adenocarcinoma
• Clinical staged T3/4 or any node-positive disease
• Age: 18-75 years
• Karnofsky Performance Status > 80
• Adequate bone marrow reserve, renal and hepatic functions
• Without previous antitumoural chemotherapy
• No evidence of metastatic disease
• Written informed consent before randomization

Exclusion Criteria

• Previous pelvis radiotherapy.
• Previous antitumoural chemotherapy
• Clinically significant internal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low instensity group	Radiotherapy	(RT 50Gy + CapOx) + Surgery
Low instensity group	Surgery	(RT 50Gy + CapOx) + Surgery
High intensity group	Radiotherapy	(RT 55Gy + CapOx) + a cycle of Xelox + Surgery
High intensity group	Surgery	(RT 55Gy + CapOx) + a cycle of Xelox + Surgery
Low instensity group	Oxaliplatin	(RT 50Gy + CapOx) + Surgery
High intensity group	Oxaliplatin	(RT 55Gy + CapOx) + a cycle of Xelox + Surgery
High intensity group	Capecitabine	(RT 55Gy + CapOx) + a cycle of Xelox + Surgery
Low instensity group	Capecitabine	(RT 50Gy + CapOx) + Surgery

Primary Outcome Measures

Name	Time	Method
toxicity	every week during radiotherapy
the rate of pathological complete response (pCR)	within 14days after surgery

Secondary Outcome Measures

Name	Time	Method
local recurrence	every half year after surgery
disease-free survival	every half year after surgery
overall survival	every half year after surgery

Trial Locations

Locations (1)

Cancer Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China