- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03824899
UGT1A1 Combined With Pharmacokinetics of SN-38 in CPT-11-based CRT in Patients With Advanced Rectal Cancer
January 30, 2019 updated by: Zhu Ji, Fudan University
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ji Zhu, PhD
- Phone Number: 81607 +86-2164175590
- Email: leo.zhu@126.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Ji Zhu, PhD
- Email: leo.zhu@126.com
-
Principal Investigator:
- Zhen Zhang, PhD
-
Sub-Investigator:
- Ji Zhu, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CRT group
Patients With Advanced Rectal Cancer receiving CPT-11-based CRT and 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
Time Frame: During the chemoradiation weekly,assessed up to 5 weeks
|
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
Time Frame: 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.
|
Surgery scheduled 6-8 weeks after the end of chemoradiation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zhen Zhang, PhD, Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2018
Primary Completion (Anticipated)
May 1, 2019
Study Completion (Anticipated)
May 1, 2020
Study Registration Dates
First Submitted
January 20, 2019
First Submitted That Met QC Criteria
January 30, 2019
First Posted (Actual)
January 31, 2019
Study Record Updates
Last Update Posted (Actual)
January 31, 2019
Last Update Submitted That Met QC Criteria
January 30, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDRT-010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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