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UGT1A1 Combined With Pharmacokinetics of SN-38 in CPT-11-based CRT in Patients With Advanced Rectal Cancer

NCT03824899 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-01-31

No results posted yet for this study

Summary

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.

Conditions

  • Locally Advanced Rectal Cancer

Interventions

DIAGNOSTIC_TEST

Blood concentration check

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhen Zhang, PhD · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2019-05-31
Completion
2020-05-31

Countries

  • China

Study Locations

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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 NCT03824899 on ClinicalTrials.gov