MedTrace Logo

Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer

NCT01977235 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2016-04-01

No results posted yet for this study

Summary

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).

Conditions

  • Small Cell Lung Carcinoma

Interventions

DRUG

Irinotecan

DRUG

Cisplatin

Sponsors & Collaborators

  • Third Military Medical University

    lead OTHER

Principal Investigators

  • Xueqin Yang, M.D. · Daping Hospital, Third Military Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-02-28
Completion
2017-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01977235 on ClinicalTrials.gov