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

Randomized Phase II Tiral of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer

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.

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