Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT05433402
Status:
WITHDRAWN
Last Update Posted:
2022-10-27
First Post:
2022-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002746', 'term': 'Chlorpromazine'}], 'ancestors': [{'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Organizational safety isues', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2022-06-22', 'lastUpdatePostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biological Markers', 'timeFrame': '6 months', 'description': 'Blood and serum level of apoptotic and inflammatory markers (Sirtuin 1 (SIRT1) - p53 - TNF-α - Caspase 3)'}], 'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': 'one year', 'description': 'Disease-free survival as measured by Logrank'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'one year', 'description': 'Overall survival as measured by Logrank'}, {'measure': 'Time occurrence of new primary colon cancer and new polyps', 'timeFrame': 'one year', 'description': 'Time occurrence of new primary colon cancer and new polyps as measured by Logrank'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colon Cancer Stage III']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age ≥18 years old.\n* Patients with histologically confirmed surgically resected stage III colon cancer\n* No rectal cancer\n* Stage III disease (any pT, N1-2, M0)\n* Patients should have a good performance status according to Eastern Cooperative Oncology Group (ECOG) score (ECOG 0-2).\n* Patients with normal organic function as defined for the following criteria:\n\n * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 times the upper normal limit of the local laboratory (LSN-LL);\n * Total serum bilirubin ≤ 2.0 x ULN-LL;\n * Absolute neutrophil count ≥ 1,500 / mm3;\n * Platelet count ≥ 100,000 / mm3;\n * Hemoglobin ≥ 8.0 g / dl;\n * Serum creatinine ≤ 1.5 x ULN-LL\n* Patients should undergone curative-intent complete surgical resection\n* Patients have at least one month from any major surgery to start of intervention\n* Written informed consent before enrollment\n\nExclusion Criteria:\n\n* 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)\n* Patients with metastatic disease\n* Patients who scheduled to receive any form of further adjuvant cancer therapy (A malignancy currently under active therapy\n* Pregnant or breast-feeding patients\n* Patients with known hypersensitivity or intolerance to CPZ\n* Patients with serious illness or psychiatric condition.\n* Patients have current participation in other protocols with experimental drugs.\n* Patients with no ability to ingest food orally.\n* Patients who have familial adenomatous polyposis, hereditary non-polyposis rectal cancer, or inflammatory bowel disease\n* Patients who are taken other chemoprevention drugs (ex. NSAIDs, Aspirin)'}, 'identificationModule': {'nctId': 'NCT05433402', 'briefTitle': 'Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sadat City University'}, 'officialTitle': 'Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer: A Pilot, Randomized, Open Label, Controlled Study.', 'orgStudyIdInfo': {'id': 'Onco-2022-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Chloropromazine', 'interventionNames': ['Drug: ChlorproMAZINE 50 MG']}], 'interventions': [{'name': 'ChlorproMAZINE 50 MG', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Chloropromazine']}, {'name': 'Control', 'type': 'DRUG', 'description': '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)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13829', 'city': 'Madīnat as Sādāt', 'state': 'Menoufia', 'country': 'Egypt', 'facility': 'Faculty of Pharmacy, University of Sadat city', 'geoPoint': {'lat': 30.36742, 'lon': 30.50871}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sadat City University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Mahmoud Samy Abdallah', 'investigatorAffiliation': 'Sadat City University'}}}}