NCT00122291

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
Last Updated

January 19, 2012

Status Verified

August 1, 2011

First QC Date

July 20, 2005

Last Update Submit

January 18, 2012

Conditions

Rectal CancerNeoplasm Metastasis

Keywords

preoperativechemotherapyradiation therapyrectal cancertransmural rectal wall invasionnodal metastasis

Outcome Measures

Primary Outcomes (2)

  • safety

  • response

Interventions

CapecitabineDRUG
Pelvic radiationPROCEDURE

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

MeSH Terms

Conditions

Rectal NeoplasmsNeoplasm Metastasis

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Gwyn Bebb, MD

    Alberta Health services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2005

First Posted

July 22, 2005

Study Start

January 1, 2002

Last Updated

January 19, 2012

Record last verified: 2011-08

Locations

CA(1)