Colon Cancer Stage III
Conditions
Brief 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.
Interventions
DRUGChlorproMAZINE 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
DRUGControl
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)
Sponsors
Sadat City University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | one year | Disease-free survival as measured by Logrank |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | one year | Overall survival as measured by Logrank |
| Time occurrence of new primary colon cancer and new polyps | one year | Time occurrence of new primary colon cancer and new polyps as measured by Logrank |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biological Markers | 6 months | Blood and serum level of apoptotic and inflammatory markers (Sirtuin 1 (SIRT1) - p53 - TNF-α - Caspase 3) |
Countries
Egypt
Outcome results
None listed