Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer
NCT ID: NCT01474187
Last Updated: 2011-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
60 participants
INTERVENTIONAL
2011-11-30
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Irinotecan
irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week
Irinotecan
initial from 50mg/m2/week and increased by 15mg/m2/week
Capecitabine
625mg/m2,bid,d1-5,qw
Radiotherapy
50Gy for whole pelvis
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Irinotecan
initial from 50mg/m2/week and increased by 15mg/m2/week
Capecitabine
625mg/m2,bid,d1-5,qw
Radiotherapy
50Gy for whole pelvis
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Clinical staged T3/4 or any node-positive disease
* Age of 18-75 years
* Karnofsky Performance Status \> 80
* Adequate bone marrow reserve, renal and hepatic functions
* Without previous antitumoural chemotherapy
* No evidence of metastatic disease
* Written informed consent before randomization
* UGT1A1's genotype of 6/6 or 6/7
Exclusion Criteria
* Age of \<18 or \>75 years
* Karnofsky Performance Status \< 80
* Previous pelvis radiotherapy
* Previous antitumoural chemotherapy
* Clinically significant internal disease
* Refuse to write informed consent before randomization
* UGT1A1's genotype of 7/7
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fudan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhu Ji
Chief of Department of Radiation Oncology, Cancer Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cancer Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ji Zhu, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FDRT-003
Identifier Type: -
Identifier Source: org_study_id