Back to resultsUGT1A1 Combined With Pharmacokinetics of SN-38 in CPT-11-based CRT in Patients With Advanced Rectal Cancer
Primary Purpose
Locally Advanced Rectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Blood concentration check
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Rectal Cancer focused on measuring neoadjuvant chemoradiotherapy, irinotecan, SN-38
Eligibility Criteria
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
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CRT group
Arm Description
Patients With Advanced Rectal Cancer receiving CPT-11-based CRT and blood concentration check
Outcomes
Primary Outcome Measures
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
pathological response rate
pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03824899
Brief Title
UGT1A1 Combined With Pharmacokinetics of SN-38 in CPT-11-based CRT in Patients With Advanced Rectal Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Rectal Cancer
Keywords
neoadjuvant chemoradiotherapy, irinotecan, SN-38
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CRT group
Arm Type
Experimental
Arm Description
Patients With Advanced Rectal Cancer receiving CPT-11-based CRT and blood concentration check
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood concentration check
Intervention Description
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
Primary Outcome Measure Information:
Title
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
Description
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
Title
pathological response rate
Description
pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen.
Time Frame
Surgery scheduled 6-8 weeks after the end of chemoradiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Zhu, PhD
Phone
+86-2164175590
Ext
81607
Email
leo.zhu@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen Zhang, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Zhu, PhD
Email
leo.zhu@126.com
First Name & Middle Initial & Last Name & Degree
Zhen Zhang, PhD
First Name & Middle Initial & Last Name & Degree
Ji Zhu, PhD
12. IPD Sharing Statement
Learn more about this trial
UGT1A1 Combined With Pharmacokinetics of SN-38 in CPT-11-based CRT in Patients With Advanced Rectal Cancer
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