NCT00535041

Brief Summary

Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 1, 2019

Status Verified

January 1, 2016

Enrollment Period

8 years

First QC Date

September 21, 2007

Last Update Submit

February 28, 2019

Conditions

Rectal Neoplasms

Keywords

Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA

Outcome Measures

Primary Outcomes (1)

  • safety

    5 years

Interventions

Chemotherapy, radiation therapy & surgeryDRUG

radiation and chemotherapy

Eligibility Criteria

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

You may qualify if:

  • Patients with localized rectal CA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KFSH&RC

Riyadh, 1211, Saudi Arabia

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Drug TherapyRadiotherapySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Shouki Bazarbashi, MD

    KFSH&RC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2007

First Posted

September 26, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 1, 2019

Record last verified: 2016-01

Locations

SA(1)