As the gene polymorphism of uridine diphosphate glucuronosyl transferase 1A1(UGT1A1)is related to the side effect of diarrhea induced by irinotecan. UGT1A1 gene \*28 (6/6 and 6/7) and \*6 (G/G and G/A) is related to low probability of diarrhea and UGT1A1 gene \*28 (7/7) and \*6 (A/A)is related to high probability of diarrhea. The purpose of this study is to find out the efficacy and side effect between two different dosages of irinotecan combined with cisplatin scheme in extensive disease-small cell lung cancer with UGT1A1 gene \*28 (6/6 and 6/7)and \*6 (G/G and G/A), based on the hypothesis that the UGT1A1 gene \*28 (7/7) and \*6 (A/A)is few in the Chinese population and increasing the dose of irinotecan can improve the efficacy without increasing the side effect in the patients with UGT1A1 gene \*28 (6/6 and 6/7)\*6 (G/G and G/A).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGXinan Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGXinqiao Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGprogression-free survival
Time frame: The first day of treatment to the date that disease progression is reported; assessed up to 3 years
overall survival
Time frame: the first day of treatment to death or last survival confirm date; assesed up to 3 years
Tumor response rate
the ratio between the number of responders and number of patients assessable for tumor response
Time frame: Up to 3 years
Toxicity
Time frame: the first date of treatment to 30 days after the last dose of study drug
Quality of life
Time frame: the day before every cycle of chemotherapy; 30 days after the last dose of study drug
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.