Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT01334593
Status:
COMPLETED
Last Update Posted:
2013-01-03
First Post:
2011-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Fitness After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-29', 'studyFirstSubmitDate': '2011-04-11', 'studyFirstSubmitQcDate': '2011-04-12', 'lastUpdatePostDateStruct': {'date': '2013-01-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Cardio Pulmonary exercise test related parameters (VO2 at AT) pre and post neoadjuvant chemoradiotherapy in rectal cancer patients.', 'timeFrame': '2 years', 'description': 'Exercise capacity (fitness) before and after NACRT will be assessed using CPET.We have pilot data on an upper gastrointestinal cancer cohort that shows that neoadjuvant chemotherapy alone results in lower levels of fitness (mean fall VO2@LT of 2.19ml/kg/min), which relates to survival before stomach and oesophageal surgery in a group of patients in Liverpool. These data also suggest that the insult of chemotherapy and surgery increases mortality'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '24784775', 'type': 'DERIVED', 'citation': 'West MA, Loughney L, Barben CP, Sripadam R, Kemp GJ, Grocott MP, Jack S. The effects of neoadjuvant chemoradiotherapy on physical fitness and morbidity in rectal cancer surgery patients. Eur J Surg Oncol. 2014 Nov;40(11):1421-8. doi: 10.1016/j.ejso.2014.03.021. Epub 2014 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and rectal) cancer is associated with improved survival, but also adversely affects physical fitness, potentially rendering patients unfit for major surgery or increasing the risk of adverse outcome (death and serious complications) after major surgery. The investigators aim to obtain pilot data showing that neoadjuvant chemoradiotherapy (NACRT)reduces objectively measured exercise capacity (fitness).', 'detailedDescription': 'Purpose: To evaluate the effects of chemoradiotherapy on pre-operative fitness of patients prior to major colorectal cancer surgery.\n\nDesign: Patients will act as their own case-control.\n\nPatients will be consented at the earliest available opportunity following the decision that they have surgically treatable disease and they consent to pre-operative NACRT. Consent for the study will be gained as an outpatient. At "visit 1" patients will undergo CPET, as is our current standard practice, prior to commencing neoadjuvant chemoradiotherapy. As part of the assessment, they will have pulmonary function testing (static lung volumes, lung diffusing capacity). They will then undergo 6 weeks of long course NACRT, as is standard current practice at our institution. At "visit 2", approximately four to six weeks following chemoradiotherapy another CPET test will be repeated. This is also current standard practice at our institution. Data from visit 1 and visit 2 will be compared in a paired manner. A statistician will be consulted to assess the degree of normality of the data, the statistical tests to use, and for power calculations. At no point will any treatments be postponed or changed solely for the purposes of collecting data for the research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Colorectal cancer is the third commonest cause of cancer related death (after breast and lung cancer) in the United Kingdom and the second commonest in non smokers. Around 100 new cases of colorectal cancer are diagnosed each day in the UK. In 2002 there were 34,889 new cases of colorectal cancer diagnosed in the United Kingdom, and approximately 17,000 deaths (CRUK 2006). Almost three quarters of bowel cancer cases occur in people aged 65 and over. Within England, mortality rates are generally higher in the north of the country.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients listed to undergo neoadjuvant chemoradiotherapy for downstaging of colorectal cancer, with a view to undergo elective colorectal surgery at Aintree University Hospitals.\n\nExclusion Criteria:\n\n* Unable to consent.\n* Under 18 years of age.\n* Significant ischaemic changes of \\>1.5mm symptomatic and \\> 2mm asymptomatic observed on routine cardiopulmonary exercise test.\n* Any other absolute contraindications to CPET based on the ATS guidelines.'}, 'identificationModule': {'nctId': 'NCT01334593', 'briefTitle': 'Assessment of Fitness After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Liverpool University Hospitals NHS Foundation Trust'}, 'officialTitle': 'The Effect of Neoadjuvant Chemoradiotherapy on Exercise Capacity in Colrectal Cancer Patients', 'orgStudyIdInfo': {'id': '11/H1002/12b'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rectal Cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L7 8XP', 'city': 'Liverpool', 'state': 'Merseyside', 'country': 'United Kingdom', 'facility': 'Aintree University Hospitals', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'Malcolm A West', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aintree University Hospitals NHS Foundation Trust, Liverpool, UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michelle Mossa', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy Research and Development Director', 'investigatorFullName': 'Michelle Mossa', 'investigatorAffiliation': 'Liverpool University Hospitals NHS Foundation Trust'}}}}