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

Locally Advanced Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03824899
• Other study ID #: FDRT-010
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: May 2020

Study information

• Verified date: January 2019
• Source: Fudan University
• Contact: Ji Zhu, PhD
• Phone: +86-2164175590
• Email: leo.zhu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

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