Status:
UNKNOWN
UGT1A1 Combined With Pharmacokinetics of SN-38 in CPT-11-based CRT in Patients With Advanced Rectal Cancer
Lead Sponsor:
Fudan University
Conditions:
Locally Advanced Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03824899
Start Date
October 10 2018
End Date
May 1 2020
Last Update
January 31 2019
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032