Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer

Phase 2

• Conditions: Rectal Cancer
• Interventions: Radiation: SIB; Radiation: conventional fraction

• Registration Number: NCT02195141
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

Pathological complete response, (pCR) correlates with a favorable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological complete remission rate.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-21
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge
• the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound

Exclusion Criteria

• metastatic disease
• Eastern Cooperative Oncology Group (ECOG) performance status > 3
• patients not deemed fit for radiotherapy, capecitabine or surgery
• pregnant or lactating patients
• women with child bearing potential who lack effective contraception
• patients below 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SIB	SIB	Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily
conventional fraction	conventional fraction	Radiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily

Primary Outcome Measures

Name	Time	Method
• Pathological complete remission rate (pCR)	after pathological examination of surgical speciments (6-8 weeks after chemoradiation)

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events (according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)	during preoperative treatment and after surgery for 5 years	Acute toxicities will be assessed every week during chemoradiation period , one week before surgery(6 weeks after chemoradiation) and every 3 months after surgery for 2 years.Late toxicities will be assessed every 6 months from the 3rd year for 3 years.Adverse eventswill be evaluated according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

Trial Locations

Locations (1)

Cancer Hospital, CAMS; 🇨🇳 Beijing, China