The study evaluates the associations between peak and valley concentrations of SN-38 with the efficacy and adverse effects of advanced rectal cancer patients carrying genotype (TA) 6 /(TA) 6 or (TA) 6 /(TA) 7 after neoadjuvant chemoradiotherapy with CPT-11.All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. The primary end point are toxicity and pCR rate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Blood concentration check:the plasma concentration of SN-38 was detected by HPLC (high-performance liquid chromatography) at 1.5 h and 49.0 h after CPT-11 infusion
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGthe morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
Time frame: During the chemoradiation weekly,assessed up to 5 weeks
pathological response rate
pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen.
Time frame: Surgery scheduled 6-8 weeks after the end of chemoradiation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.