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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT01310985
First received: March 6, 2011
Last updated: February 24, 2016
Last verified: December 2011
  Purpose
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

Condition Intervention
Colon Rectal Cancer Duke Stage Stageval
Drug: Capecitabine (Xelodaâ), XRT & Cetuximab (Erbitux®)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: 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

Resource links provided by NLM:


Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • Evaluate the safety of pre-operative concurrent chemotherapy with capacitabine (Xeloda), weekly cetuximab (Erbitux), and external beam radiation. [ Time Frame: For the duration of the experiment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate efficacy of sphincter preserving surgery rate, local recurrence rate and the disease free and overall survival in patients. [ Time Frame: For the duration of the experiment ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: March 2008
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Capecitabine (Xelodaâ), XRT & Cetuximab (Erbitux®)
    Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®)
    Other Name: Capecitabine (Xelodaâ), XRT& Cetuximab (Erbitux®)
Detailed Description:
Its a pilot study of pre-op chemotherapy and RT utilizing CAPECITABINE, XRT and CETUXIMAB in pts with locally advanced rectal carcinoma.
  Eligibility

Ages Eligible for Study:   14 Years to 85 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Localized (Non-Metastatic) Rectal Cancer
Criteria

Inclusion Criteria:

  • Patients with Localized Non-Metastatic Rectal Cancer

Exclusion Criteria:

  • Patients with diagnosis other than Localized Non-Metastatic Rectal Cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310985

Locations
Saudi Arabia
Kfsh & Rc
Riyadh, Saudi Arabia
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Shouki Bazarbashi, M.D. KFSH & RC
  More Information

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT01310985     History of Changes
Other Study ID Numbers: RAC# 2071-051  RAC# 2071-051 
Study First Received: March 6, 2011
Last Updated: February 24, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by King Faisal Specialist Hospital & Research Center:
Rectal Cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Capecitabine
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 07, 2016