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

Not Applicable

• Conditions: Locally Advanced Rectal Cancer
• Interventions: Diagnostic Test: Blood concentration check

• Registration Number: NCT03824899
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-10-10
• Status Verified: 2019-01
• Study First Submitted: 2019-01-20
• Study First Submitted QC: 2019-01-30
• Last Update Submitted: 2019-01-30
• Study First Posted: 2019-01-31
• Last Update Posted: 2019-01-31
• Primary Completion: 2019-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CRT group	Blood concentration check	Patients With Advanced Rectal Cancer receiving CPT-11-based CRT and blood concentration check

Primary Outcome Measures

Name	Time	Method
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0	During the chemoradiation weekly，assessed up to 5 weeks	the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
pathological response rate	Surgery scheduled 6-8 weeks after the end of chemoradiation	pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China