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

The Application of UGT1A1 Genotype Combined With Pharmacokinetics of SN-38 in the Detection of Irinotecan-based Neoadjuvant Chemoradiotherapy in Patients With Advanced Rectal Cancer

Sponsors

Lead Sponsor: Fudan University

Source Fudan University
Brief 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.
Overall Status Unknown status
Start Date 2018-10-10
Completion Date 2020-05-01
Primary Completion Date 2019-05-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0 During the chemoradiation weekly，assessed up to 5 weeks
pathological response rate Surgery scheduled 6-8 weeks after the end of chemoradiation
Enrollment 100
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Blood concentration check

Description: 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

Arm Group Label: CRT group

Eligibility

Criteria:

Inclusion Criteria: - pathological confirmed adenocarcinoma - clinical stage T3-4 and/or N+ - the distance from anal verge less than 12 cm - without distance metastases - performance status score: 0~1 - UGT1A1*28 6/6 or 6/7 - without previous anti-cancer therapy - sign the inform consent Exclusion Criteria: - pregnancy or breast-feeding women - serious medical illness - baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN - DPD deficiency - UGT1A1*28 7/7

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No
Overall Official
Last Name Role Affiliation
Zhen Zhang, PhD Principal Investigator Fudan University
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Status: Contact: Investigator: Fudan University Shanghai Cancer Center Ji Zhu, PhD [email protected] Zhen Zhang, PhD Principal Investigator Ji Zhu, PhD Sub-Investigator
Location Countries

China
Verification Date

2019-01-01
Responsible Party

Type: Principal Investigator

Investigator Affiliation: Fudan University

Investigator Full Name: Zhu Ji

Investigator Title: professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: CRT group

Type: Experimental

Description: Patients With Advanced Rectal Cancer receiving CPT-11-based CRT and blood concentration check

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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