IMRT-SIB and Capecitabine in Preoperative Rectal Cancer Treatment
Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
RATIONALE: Using small radiation beamlets of different intensity, IMRT (intensity modulated
radiation therapy) allows shaping the dose around planning target volume with better sparing
of normal tissue comparing to 3D conformal radiotherapy. It allows daily delivery of higher
dose to the tumor with simultaneous integrated boost (SIB), consequently shortening total
treatment time with potentially better response to treatment. In advanced rectal
adenocarcinoma excellent response to preoperative radiochemotherapy with complete eradication
of the primary tumor observed in the histopathological specimen (pathological complete
response, pCR) correlates with a favorable overall prognosis, so trying to achieve better
response to preoperative treatment with higher pCR seams feasible.
PURPOSE:The hypothesis of this study is that in preoperative radiochemotherapy for locally
advanced rectal adenocarcinoma shortening of the total treatment time with IMRT-SIB to 22
daily fractions concomitant with capecitabine results in an improved pCR rate from 9%
(Slovenian trial) to 25%. Secondary objectives are to evaluate pathological down-staging
rate, histopathological R0 resection rate, sphincter preservation rate, perioperative
surgical complication rate, local control, disease-free survival (DFS), overall survival
(OS), late toxicity and quality of life.