Chemotherapy With DNA Damaging Agents In Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Treatment with chemotherapy
Only chemotherapy treatment for study cohort
surgery
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring DNA damaging agents
Eligibility Criteria
Inclusion Criteria:
- patients that did not underwent surgery
Exclusion Criteria:
- patients that underwent surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control (chemotherapy and surgery)
Study
Arm Description
Patients treated with chemotherapy + surgery
Patients treated only with chemotherapy
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01456923
First Posted
October 18, 2011
Last Updated
October 20, 2011
Sponsor
Centro Hospitalar Nordeste
1. Study Identification
Unique Protocol Identification Number
NCT01456923
Brief Title
Chemotherapy With DNA Damaging Agents In Colorectal Cancer
Official Title
Phase 1 Study Of The Efficacy Of Chemotherapy With DNA Damaging Agents Versus Surgery In Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Hospitalar Nordeste
4. Oversight
5. Study Description
Brief Summary
Chemotherapy Treatment alone with DNA damaging drugs might be as effective as chemotherapy combined with surgery in colorectal cancer (CRC) avoiding surgery complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
DNA damaging agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
8. Arms, Groups, and Interventions
Arm Title
Control (chemotherapy and surgery)
Arm Type
Active Comparator
Arm Description
Patients treated with chemotherapy + surgery
Arm Title
Study
Arm Type
Active Comparator
Arm Description
Patients treated only with chemotherapy
Intervention Type
Other
Intervention Name(s)
Treatment with chemotherapy
Intervention Type
Other
Intervention Name(s)
Only chemotherapy treatment for study cohort
Intervention Description
Control patients were treated both with surgery and chemotherapy. Study patients were treated only with chemotherapy
Intervention Type
Procedure
Intervention Name(s)
surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- patients that did not underwent surgery
Exclusion Criteria:
- patients that underwent surgery
12. IPD Sharing Statement
Learn more about this trial
Chemotherapy With DNA Damaging Agents In Colorectal Cancer
We'll reach out to this number within 24 hrs