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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: Rectal Cancer

Treatments: Radiation: conventional fraction; Radiation: SIB

Study type: Interventional

Funder types: Other

Identifiers

NCT02195141

NCC2014-ST02

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

conventional fraction

Active Comparator group

Description:

Radiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily

Treatment:

Radiation: conventional fraction

SIB

Experimental group

Description:

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

Treatment:

Radiation: SIB