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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
Centro Hospitalar Nordeste
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring DNA damaging agents

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 18, 2011
    Last Updated
    October 20, 2011
    Sponsor
    Centro Hospitalar Nordeste
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    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

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