Clinical Study Evaluating the Efficacy and Safety of Sulfasalazine in Patients With Metastatic Colorectal Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The aim of this study is to evaluate the potential efficacy and safety of sulfasalazine in patients with metastatic colorectal cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• Histologically confirmed diagnosis of stage IV (metastatic) colorectal cancer. Staging will be performed according to the American Joint Committee on Cancer (AJCC) 8th edition and will be documented by all investigating parameters of metastatic colorectal cancer

• Male or female patients with age range from 18-65 years old

• Women of childbearing age will be required to be on acceptable forms of contraception

• Performance status \< 2 according to the Eastern Cooperative Oncology Group (ECOG) score

• No contraindication to chemotherapy (absence of myelosuppression)

• Adequate liver function (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< grade 2) according to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v 5.0)

• Adequate renal function (estimated creatinine clearance (eCrCl), serum creatinine (SCr) \< grade 2) according to NCI-CTCAE, v 5.0

• Adequate hematological parameters (hemoglobin, erythrocytes, platelets, leukocytes and absolute neutrophil count (ANC) \< grade 2 according to NCI-CTCAE, v 5.0

Locations
Other Locations
Egypt
Tanta University Hospital
RECRUITING
Tanta
Contact Information
Primary
Reham A. El-Ghoneimy, M.Sc in Clinical Pharmacy
reham.elghonemy@pharm.tanta.edu.eg
+201151896761
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-09
Participants
Target number of participants: 50
Treatments
No_intervention: Control Group
This group will include 25 patients who will be scheduled to receive 6 cycles of 5-Fluorouracil and Oxaliplatin- based regimens every 2 weeks for 3 months.
Active_comparator: Sulfasalazine Group
This group will include 25 patients who will be scheduled to receive 6 cycles of 5-Fluorouracil and Oxaliplatin- based regimens every 2 weeks plus sulfasalazine (1 gram orally twice daily) for 3 months.
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov