Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT04074460
Status:
COMPLETED
Last Update Posted:
2022-06-09
First Post:
2019-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D007530', 'term': 'Isoflurane'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D000077335', 'term': 'Desflurane'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D005019', 'term': 'Ethyl Ethers'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients are blinded to the anaesthetic type given. Statistician also blinded.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-08', 'studyFirstSubmitDate': '2019-08-15', 'studyFirstSubmitQcDate': '2019-08-27', 'lastUpdatePostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To measure the ability to recruit eligible patients into the study.', 'timeFrame': '18 months', 'description': 'The study protocol will be assessed as feasible if a recruitment rate of at least 75% is achieved.'}, {'measure': 'To measure the ability to successfully deliver each of the two anaesthetic techniques (volatile-based general anaesthesia and propofol-based anaesthesia) according to the research protocol.', 'timeFrame': '18 months', 'description': 'The study protocol will be assessed as feasible if a successful delivery rate of at least 90% is achieved.'}], 'secondaryOutcomes': [{'measure': 'To identify that all sites can capture data within the electronic case report form (eCRF) and utilize the electronic data capturing system (REDCap).', 'timeFrame': '18 months', 'description': 'All missing data to be recorded including reason for missing data, where available. Quantitative and qualitative analysis of reasons for missing data will be analysed by : Number of fields with missing data (percentage) and reason for missing data ( qualitative descriptor). Fields with \\>1 missing data point will be analysed for reasons for failure.'}, {'measure': 'To test the efficiency of the centralized patient enrolment and computer randomization system.', 'timeFrame': '18 months', 'description': 'Number of events of failed randomisation will be recorded on eCRF (under \'treatment of subjects"). Quantitative analysis of failed randomisation (reported as %) as well as descriptive reason for failure will be recorded and analysed. This will allow shortcomings in the use of the computer-generated centralised randomisation program to be identified and ratified.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['major surgeries lasting >2 hours'], 'conditions': ['Cancer, Breast', 'Cancer Colorectal', 'Cancer Prostate', 'Cancer, Lung', 'Cancer Melanoma Skin', 'Cancer, Other']}, 'descriptionModule': {'briefSummary': 'A multicentre, prospective randomized, active-controlled feasibility trial of volatile-based anaesthesia vs. propofol-based total intravenous anaesthesia to investigate the impact of anaesthesia on long-term (i.e. 5-years) patient cancer outcomes in patients undergoing elective major cancer surgery.', 'detailedDescription': 'This study aims to assess the feasibility of conducting a phase IV, multi-centre, single-blinded, randomized control trial (VAPOR-C (Main)).\n\nPrimary aims To measure the ability to recruit eligible patients into the study.\n\nTo measure the ability to successfully deliver each of the two anaesthetic techniques (volatile-based general anaesthesia and propofol-based anaesthesia) according to the research protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Age 18-80 years\n* Elective surgery\n* Major cancer surgery expecting to last two or more hours, for:\n* Breast (mastectomy or segmentectomy plus sentinel node dissection)\n* Colorectal\n* Lung\n* Prostate\n* Melanoma (excision of melanoma plus lymph node dissection AND/OR skin flap construction\n* Other major cancer surgeries (e.g. oesophagectomy, head and neck cancer, etc.)\n\nExclusion Criteria\n\n* Palliative surgery for end-stage disease with no curative intent\n* Emergency surgery\n* Extensive comorbid disease, i.e. American Society of Anesthesiologists (ASA) Score \\> 4\n* Age \\<18 or \\>80 years old\n* Refusal or inability to provide valid informed consent\n* Risk of severe postoperative nausea and vomiting (PONV risk score \\>3)\n* Previous allergy or contraindication to either anaesthetic medication\n* Indication for gas induction of anaesthesia\n* Currently enrolled in another clinical trial unless agreed by the coordinating principal investigator and site principal investigator that co-enrolment can occur.'}, 'identificationModule': {'nctId': 'NCT04074460', 'acronym': 'VAPOR-C', 'briefTitle': 'Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Peter MacCallum Cancer Centre, Australia'}, 'officialTitle': 'Volatile Anaesthesia and Perioperative Outcomes Related to Cancer (VAPOR-C): A Feasibility Study', 'orgStudyIdInfo': {'id': '16/144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol (TIVA)', 'description': 'Propofol-based total intravenous anaesthesia', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Volatile', 'description': 'Volatile-based (isoflurane, sevoflurane or desflurane) general anaesthesia', 'interventionNames': ['Drug: isoflurane, sevoflurane or desflurane']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'General Anaesthesia', 'armGroupLabels': ['Propofol (TIVA)']}, {'name': 'isoflurane, sevoflurane or desflurane', 'type': 'DRUG', 'description': 'General Anaesthesia', 'armGroupLabels': ['Volatile']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Melbourne', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter MacCallum Cancer Centre, Australia', 'class': 'OTHER'}, 'collaborators': [{'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, {'name': 'Melbourne Health', 'class': 'OTHER'}, {'name': 'The Alfred', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}