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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High intensity group

(RT 55Gy + CapOx) + a cycle of Xelox + Surgery

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

CRT:50mg/m2,IV,weekly\*5 cycle CT: 130mg/m2,IV,d1,q 21 day

Capecitabine

Intervention Type DRUG

CRT:625mg/m2,bid,d1-5,q week RT:1000mg/m2,bid,d1-14,q 3 weeks

Radiotherapy

Intervention Type RADIATION

High intensity group:55Gy Low intensity group:50Gy

Surgery

Intervention Type PROCEDURE

Lower anterior resection or abdominoperineal resection

Low instensity group

(RT 50Gy + CapOx) + Surgery

Group Type ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type DRUG

CRT:50mg/m2,IV,weekly\*5 cycle CT: 130mg/m2,IV,d1,q 21 day

Capecitabine

Intervention Type DRUG

CRT:625mg/m2,bid,d1-5,q week RT:1000mg/m2,bid,d1-14,q 3 weeks

Radiotherapy

Intervention Type RADIATION

High intensity group:55Gy Low intensity group:50Gy

Surgery

Intervention Type PROCEDURE

Lower anterior resection or abdominoperineal resection

Interventions

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Oxaliplatin

CRT:50mg/m2,IV,weekly\*5 cycle CT: 130mg/m2,IV,d1,q 21 day

Intervention Type DRUG

Capecitabine

CRT:625mg/m2,bid,d1-5,q week RT:1000mg/m2,bid,d1-14,q 3 weeks

Intervention Type DRUG

Radiotherapy

High intensity group:55Gy Low intensity group:50Gy

Intervention Type RADIATION

Surgery

Lower anterior resection or abdominoperineal resection

Intervention Type PROCEDURE

Eligibility Criteria

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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