A Trial of Pre-Operative Chemoradiotherapy Using Capecitabine, Radiation & Cetuximab, in Rectal Cancer

NCT ID: NCT01310985

Last Updated: 2019-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2014-08-31

Brief Summary

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A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized (Non-Metastatic) Rectal Cancer

Detailed Description

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Its a pilot study of pre-op chemotherapy and RT utilizing CAPECITABINE, XRT and CETUXIMAB in pts with locally advanced rectal carcinoma.

Conditions

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Colon Rectal Cancer Duke Stage Stageval

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Capecitabine (Xelodaâ), XRT & Cetuximab (Erbitux®)

Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®)

Intervention Type DRUG

Other Intervention Names

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Capecitabine (Xelodaâ), XRT& Cetuximab (Erbitux®)

Eligibility Criteria

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Inclusion Criteria

* Patients with Localized Non-Metastatic Rectal Cancer

Exclusion Criteria

* Patients with diagnosis other than Localized Non-Metastatic Rectal Cancer
Minimum Eligible Age

14 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shouki Bazarbashi, M.D.

Role: PRINCIPAL_INVESTIGATOR

KFSH & RC

Locations

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Kfsh & Rc

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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RAC# 2071-051

Identifier Type: OTHER

Identifier Source: secondary_id

RAC# 2071-051

Identifier Type: -

Identifier Source: org_study_id

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