A Phase 1/2 interventional study of ChlorproMAZINE 50 MG and Control in Colon Cancer Stage III, sponsored by Sadat City University. Withdrawn at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-10-27.
Sponsored by Sadat City University · Phase 1/2, Interventional, and Treatment
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.
1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.
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Patients with normal organic function as defined for the following criteria:
Exclusion Criteria:
Drug: Control
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
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)
Disease-free survival
Disease-free survival as measured by Logrank
Time frame: one year
Overall survival
Overall survival as measured by Logrank
Time frame: one year
Time occurrence of new primary colon cancer and new polyps
Time occurrence of new primary colon cancer and new polyps as measured by Logrank
Time frame: one year
Biological Markers
Blood and serum level of apoptotic and inflammatory markers (Sirtuin 1 (SIRT1) - p53 - TNF-α - Caspase 3)
Time frame: 6 months
Plan to share: Yes
Supporting information: Study protocol, Informed consent form
No publications or documents are linked to this record.
This study is withdrawn, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Chlorpromazine
Sadat City University