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出境医 / 临床实验 / Mebendazole as Adjuvant Treatment for Colon Cancer

Mebendazole as Adjuvant Treatment for Colon Cancer

Study Description
Brief Summary:
mebendazole treating colon cancer

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Folfox with avastin Drug: Mebendazole Phase 3

Detailed Description:
mebendazole as adjuvant treatment for colon cancer
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study Evaluating Mebendazole as Adjuvant Therapy in Patients With Colorectal Cancer
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 2028
Estimated Study Completion Date : December 2028
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Folfox with avastin
Folfox with avastin only
 Drug: Folfox with avastin
Folfox with avastin only
Other Name: folfox 4
Experimental: Mebendazole
Folfox with avastin with mebendazole
 Drug: Mebendazole
Folfox with avastin with mebendazole
Other Name: mebendazol
Outcome Measures
Primary Outcome Measures :
  1. number of patients with tumour response [ Time Frame: 6 months ]
    number of patients with response


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Colorectal cancer stage 4.

Exclusion Criteria:

  • Agranulocytosis
  • Pregnancy
  • Allergy to mebendazole.
Contacts and Locations

Contacts
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Contact: Sherief Abd-Elsalam, ass. prof. 00201147773440 sheriefabdelsalam@yahoo.com

Locations
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Egypt
Sherief Abd-Elsalam Recruiting
Cairo, Egypt
Contact: Sherief Abd-elsalam, lecturer    00201000040794    Sherif_tropical@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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Principal Investigator: Reham El-ghoneimy, Msc Tanta University - Faculty of Pharmacy
Principal Investigator: Sahar Hegazy, Prof Tanta University - Faculty of Pharmacy
Study Director: Gamal el-azab, Prof Tanta University - Faculty of Pharmacy
Study Chair: Fatma Zakaria, Prof Clinical Oncology department. Tanta University.
Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date April 24, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date December 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019) 		number of patients with tumour response [ Time Frame: 6 months ]
number of patients with response
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mebendazole as Adjuvant Treatment for Colon Cancer
Official Title  ICMJE Clinical Study Evaluating Mebendazole as Adjuvant Therapy in Patients With Colorectal Cancer
Brief Summary mebendazole treating colon cancer
Detailed Description mebendazole as adjuvant treatment for colon cancer
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Folfox with avastin
    Folfox with avastin only
    Other Name: folfox 4
  • Drug: Mebendazole
    Folfox with avastin with mebendazole
    Other Name: mebendazol
Study Arms  ICMJE
  • Active Comparator: Folfox with avastin
    Folfox with avastin only
    Intervention: Drug: Folfox with avastin
  • Experimental: Mebendazole
    Folfox with avastin with mebendazole
    Intervention: Drug: Mebendazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2028
Estimated Primary Completion Date December 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Colorectal cancer stage 4.

Exclusion Criteria:

  • Agranulocytosis
  • Pregnancy
  • Allergy to mebendazole.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sherief Abd-Elsalam, ass. prof. 00201147773440 sheriefabdelsalam@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03925662
Other Study ID Numbers  ICMJE colon cancer
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sherief Abd-Elsalam, Tanta University
Study Sponsor  ICMJE Sherief Abd-Elsalam
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Reham El-ghoneimy, Msc Tanta University - Faculty of Pharmacy
Principal Investigator: Sahar Hegazy, Prof Tanta University - Faculty of Pharmacy
Study Director: Gamal el-azab, Prof Tanta University - Faculty of Pharmacy
Study Chair: Fatma Zakaria, Prof Clinical Oncology department. Tanta University.
PRS Account Tanta University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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