Mebendazole as Adjuvant Treatment for Colon Cancer

Sponsor

Sherief Abd-Elsalam (Other)

Overall Status

Recruiting

CT.gov ID

NCT03925662

Collaborator

(none)

Enrollment

Location

Arms

116

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2028

Anticipated Study Completion Date :

Dec 1, 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 Names: folfox 4
Experimental: Mebendazole Folfox with avastin with mebendazole	Drug: Mebendazole Folfox with avastin with mebendazole Other Names: mebendazol

Arm

Intervention/Treatment

Active Comparator: Folfox with avastin

Folfox with avastin only

Drug: Folfox with avastin

Folfox with avastin only

Other Names:

folfox 4

Experimental: Mebendazole

Folfox with avastin with mebendazole

Drug: Mebendazole

Folfox with avastin with mebendazole

Other Names:

mebendazol

Outcome Measures

Primary Outcome Measures

number of patients with tumour response [6 months]
number of patients with response

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Colorectal cancer stage 4.

Exclusion Criteria:

Agranulocytosis
Pregnancy
Allergy to mebendazole.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sherief Abd-Elsalam	Cairo		Egypt

Sponsors and Collaborators

Sherief Abd-Elsalam

Investigators

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.