Chemotherapy With DNA Damaging Agents In Colorectal Cancer | NCT01456923

Studies
Chemotherapy With DNA Damaging Agents In Colorectal Cancer

NCT01456923

Sponsor

Centro Hospitalar Nordeste

Status

Completed

Last Update Posted

Oct 21, 2011Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Colorectal Cancer

Interventions

Treatment with chemotherapy
Only chemotherapy treatment for study cohort
surgery

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 18, 2011

First Submission Date that Met QC Criteria

Oct 20, 2011

First Posted Date

Oct 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2011

Last Update Posted Date

Oct 21, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control (chemotherapy and surgery)	Active Comparator	Patients treated with chemotherapy + surgery	Other: Treatment with chemotherapy Procedure: surgery
Study	Active Comparator	Patients treated only with chemotherapy	Other: Only chemotherapy treatment for study cohort

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment with chemotherapy	Other		Control (chemotherapy and surgery)
Only chemotherapy treatment for study cohort

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- patients that did not underwent surgery

Exclusion Criteria:

- patients that underwent surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics
D004358	Drug Therapy
D015331	Cohort Studies
D013514	Surgical Procedures, Operative

Ancestor Terms

ID	Term
D016021	Epidemiologic Studies
D016020	Epidemiologic Study Characteristics
D004812	Epidemiologic Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided