Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer

• ChlorproMAZINE 50 MG (Drug): 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 (Drug): 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)

Primary outcomes

• Disease-free survival [one year]: Disease-free survival as measured by Logrank

Secondary outcomes

• 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 outcomes

• Biological Markers [6 months]: Blood and serum level of apoptotic and inflammatory markers (Sirtuin 1 (SIRT1) - p53 - TNF-α - Caspase 3)

Sex: All, ages: 18 Years to 60 Years

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)