The hypothesis of this study is that dose escalated intensity modulated radiotherapy (IMRT) to a dose of 55Gy in 25# to primary rectal tumor concurrent with oral capecitabine results in an improved pathological response rate from 8% (German trial) to 25%.
This study aims to look at whether radiation dose escalation with intensity modulated radiotherapy can increase the rates of pathological complete response in patients with locally advanced rectal cancer treated with neoadjuvant chemoradiotherapy
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Intensity modulated radiotherapy to a dose of 55Gy in 25 fractions
National University Hospital
Singapore, Singapore, Singapore
RECRUITINGPathological complete response rates
Pathogical complete response rate 8 weeks post chemoradiotherapy at surgery according to Ryan's classification
Time frame: 8 weeks post chemoradiotherapy
Toxicity
Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis, proctitis, urinary frequency/urgency as per common toxicity criteria v3.0
Time frame: 2 years
Disease Free survival
Time from study entry to disease recurrence or death
Time frame: 2 years
Downstaging rates
percentage of patients who achieve downstaging 8 weeks post chemoradiotherapy at surgery according to TNM classification
Time frame: 8 weeks after chemoradiotherapy
Sphincter Preservation rates
Sphincter Preservation rates 8 weeks post chemoradiotherapy at surgery.Percentage of patients who underwent sphincter salvage surgery after chemoradiotherapy
Time frame: 8 weeks after chemoradiotherapy
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