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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05433402
Other study ID # Onco-2022-7
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date July 20, 2022
Est. completion date September 30, 2022

Study information

Verified date October 2022
Source Sadat City University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

chlorpromazine displays a series of remarkable bio-molecular effects in cancer cells, as inhibition of cell growth, nuclear aberrations, inhibition of the phosphoinositide 3-kinase/mammilian target of rapamycin (PI3K/mTOR) axis, induction of cytotoxic autophagy, inhibition of glutamate and DRD2 receptors. This study will evaluate the addition of chlorpromazine to the first-line therapeutic protocol in colon cancer stage III.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Patients age =18 years old. - Patients with histologically confirmed surgically resected stage III colon cancer - No rectal cancer - Stage III disease (any pT, N1-2, M0) - Patients should have a good performance status according to Eastern Cooperative Oncology Group (ECOG) score (ECOG 0-2). - Patients with normal organic function as defined for the following criteria: - Aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 2.5 times the upper normal limit of the local laboratory (LSN-LL); - Total serum bilirubin = 2.0 x ULN-LL; - Absolute neutrophil count = 1,500 / mm3; - Platelet count = 100,000 / mm3; - Hemoglobin = 8.0 g / dl; - Serum creatinine = 1.5 x ULN-LL - Patients should undergone curative-intent complete surgical resection - Patients have at least one month from any major surgery to start of intervention - Written informed consent before enrollment Exclusion Criteria: - Patients with concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in-situ cervical cancer) - Patients with metastatic disease - Patients who scheduled to receive any form of further adjuvant cancer therapy (A malignancy currently under active therapy - Pregnant or breast-feeding patients - Patients with known hypersensitivity or intolerance to CPZ - Patients with serious illness or psychiatric condition. - Patients have current participation in other protocols with experimental drugs. - Patients with no ability to ingest food orally. - Patients who have familial adenomatous polyposis, hereditary non-polyposis rectal cancer, or inflammatory bowel disease - Patients who are taken other chemoprevention drugs (ex. NSAIDs, Aspirin)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ChlorproMAZINE 50 MG
The experimentall group will receive folinic acid, fluorouracil and oxaliplatin (mFOLFOX6) regimen every 14 days for (6-12 cycles) (6 months) (Day 1: 5-FU IV 400 mg/m2, leucovorin IV 400 mg/m2, oxaliplatin IV 85 mg/m2, 5-FU continuous IV infusion (CIVI) 1200 mg/m2/day x 2 days (over 46-48 hours) plus choloropromazine 50 mg daily for 6 months
Control
The control group will receive folinic acid, fluorouracil and oxaliplatin (mFOLFOX6) regimen every 14 days for (6-12 cycles) (6 months) (Day 1: 5-FU IV 400 mg/m2, leucovorin IV 400 mg/m2, oxaliplatin IV 85 mg/m2, 5-FU continuous IV infusion (CIVI) 1200 mg/m2/day x 2 days (over 46-48 hours)

Locations

Country Name City State
Egypt Faculty of Pharmacy, University of Sadat city Sadat City Menoufia

Sponsors (1)

Lead Sponsor Collaborator
Sadat City University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Biological Markers Blood and serum level of apoptotic and inflammatory markers (Sirtuin 1 (SIRT1) - p53 - TNF-a - Caspase 3) 6 months
Primary Disease-free survival Disease-free survival as measured by Logrank one year
Secondary Overall survival Overall survival as measured by Logrank one year
Secondary Time occurrence of new primary colon cancer and new polyps Time occurrence of new primary colon cancer and new polyps as measured by Logrank one year
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