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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2018
CompletedFirst Submitted
Initial submission to the registry
January 20, 2019
CompletedFirst Posted
Study publicly available on registry
January 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedJanuary 31, 2019
January 1, 2019
7 months
January 20, 2019
January 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
CRT group
EXPERIMENTALPatients With Advanced Rectal Cancer receiving CPT-11-based CRT and blood concentration check
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Study Officials
- PRINCIPAL INVESTIGATOR
Zhen Zhang, PhD
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
January 20, 2019
First Posted
January 31, 2019
Study Start
October 10, 2018
Primary Completion
May 1, 2019
Study Completion
May 1, 2020
Last Updated
January 31, 2019
Record last verified: 2019-01