A Study of Preoperative Radiation Therapy and Capecitabin... | NCT00122291

Studies
A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer

NCT00122291

Sponsor

Alberta Health services

Status

Unknown status

Last Update Posted

Jan 19, 2012Estimated

Enrollment

66Estimated

Phase

Phase 2

Conditions

Rectal Cancer
Neoplasm Metastasis

Interventions

Capecitabine
Pelvic radiation

Countries

Canada

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

ID	Type	Description	Link
Capecitabine Phase 2

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 20, 2005

First Submission Date that Met QC Criteria

Jul 20, 2005

First Posted Date

Jul 22, 2005Estimated

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

Jan 18, 2012

Last Update Posted Date

Jan 19, 2012Estimated

Description Module

Brief Summary

The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.

Detailed Description

The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biopsy - proven rectal cancer
Transmural rectal wall invasion
Karnofsky performance status >70
Normal bone marrow, liver and kidney function

Exclusion Criteria:

Distant metastases
Prior pelvic radiation
Inflammatory bowel disease
Severe ischemic heart disease
Anticoagulant therapy
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gwyn Bebb, MD	Alberta Health services	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tom Baker Cancer Centre		Calgary	Alberta	T2N 4N2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069287	Capecitabine

Ancestor Terms

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
safety
response

Name	Type	Description	Arm Group Labels	Other Names
Capecitabine	Drug
Pelvic radiation	Procedure