Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT01604005
Status:
TERMINATED
Last Update Posted:
2018-01-29
First Post:
2012-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008654', 'term': 'Mesothelioma'}], 'ancestors': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 375}}, 'statusModule': {'whyStopped': 'CI Decision:That once the last patient has reached 1 year follow-up, no further follow up needs to be completed on patients recruited in PIT"', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-26', 'studyFirstSubmitDate': '2012-05-21', 'studyFirstSubmitQcDate': '2012-05-21', 'lastUpdatePostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of chest wall tract metastasis 6 months from randomisation', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Time from randomisation to chest wall tract metastasis', 'timeFrame': 'Weeks', 'description': 'Patients will be assessed at regular intervals approximately every 4 weeks by phone and at regular outpatient visits in the first year of follow up for signs of chest wall metastasis'}, {'measure': 'Position of chest wall tract metastasis recurrence in relation to radiotherapy field in patients randomised to experimental arm (in field/out-of-field)', 'timeFrame': 'Weeks', 'description': 'Patients will be assessed at regular intervals approximately every 4 weeks by phone and at regular outpatient visits in the first year of follow up for signs of chest wall metastasis'}, {'measure': 'Acute and late skin radiotherapy toxicity', 'timeFrame': 'Weeks', 'description': 'Patient will attend hospital at 6, 12, 26 and 52 weeks post randomisation where toxicity to PIT will be assessed.\n\nCTCAE v4.0 will be used'}, {'measure': 'Pain from chest wall tract metastasis', 'timeFrame': 'Weeks', 'description': 'Patients will be assessed at regular intervals approximately every 4 weeks by phone and at regular outpatient visits in the first year of follow for pain scoring using a Visual Analogue Scale (VAS)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mesothelioma', 'radiotherapy', 'prophylactic irradiation of tracts'], 'conditions': ['Mesothelioma']}, 'referencesModule': {'references': [{'pmid': '30920878', 'type': 'DERIVED', 'citation': 'Bayman N, Appel W, Ashcroft L, Baldwin DR, Bates A, Darlison L, Edwards JG, Ezhil V, Gilligan D, Hatton M, Jegannathen A, Mansy T, Peake MD, Pemberton L, Rintoul RC, Snee M, Ryder WD, Taylor P, Faivre-Finn C. Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma: An Open-Label, Multicenter, Phase III Randomized Trial. J Clin Oncol. 2019 May 10;37(14):1200-1208. doi: 10.1200/JCO.18.01678. Epub 2019 Mar 28.'}, {'pmid': '26817643', 'type': 'DERIVED', 'citation': 'Bayman N, Ardron D, Ashcroft L, Baldwin DR, Booton R, Darlison L, Edwards JG, Lang-Lazdunski L, Lester JF, Peake M, Rintoul RC, Snee M, Taylor P, Lunt C, Faivre-Finn C. Protocol for PIT: a phase III trial of prophylactic irradiation of tracts in patients with malignant pleural mesothelioma following invasive chest wall intervention. BMJ Open. 2016 Jan 27;6(1):e010589. doi: 10.1136/bmjopen-2015-010589.'}], 'seeAlsoLinks': [{'url': 'http://www.christie.nhs.uk/', 'label': 'Christie NHS website'}]}, 'descriptionModule': {'briefSummary': 'The PIT (Prophylactic Irradiation of Tracts) trial will determine whether or not PIT radiotherapy is effective in preventing or delaying the onset of chest nodules in patients with Mesothelioma.', 'detailedDescription': "Mesothelioma is a rare form of cancer affecting the protective lining that covers many of the body's internal organs. The most commonly affected areas are the lungs and internal chest wall. In the UK over 2300 patients are diagnosed with mesothelioma each year and the numbers are increasing.\n\nAs part of the diagnosis and treatment of mesothelioma, patients may undergo a procedure which involves inserting a thin tube into the chest wall enabling an internal examination and for any biopsies or samples of fluid to be taken. These procedures can result in the development of skin lumps or nodules along the tract created by inserting the tube. To try and reduce the risk of these nodules developing in the tract or at the site of the scar, radiotherapy can be given to the chest wall at the site of the tract after the procedure has been performed; this type of radiotherapy is known as prophylactic irradiation of tracts or PIT.\n\nAlthough many hospitals already give patients this type of radiotherapy treatment to the chest wall we still do not know if the treatment works. This trial has been designed to answer the question about the effectiveness of PIT radiotherapy. If PIT is found to be effective in preventing or delaying the development of these skin nodules then it can be offered to all patients as part of their treatment. However, if we discover that PIT is not effective this will save patients from undergoing ineffective treatment and having to spend time making unnecessary extra visits to hospital"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Either sex, age ≥ 18 years\n* Diagnosis of mesothelioma by multi-disciplinary team (MDT). All histological subtypes are eligible for the trial\n* ECOG performance status 0-2 (Appendix C)\n* Inoperable disease or operable disease in patients unsuitable for surgery as decided by a MDT\n* Chest wall intervention with video-assisted thoracoscopy (VATS), open surgical biopsy (mini-thoracotomy), local anaesthetic thoracoscopy or chest drain\n* Able to start radiotherapy within 42 days (6 weeks) of the most recent chest wall procedure\n* Chest wall intervention scar visible at time of randomisation\n* Radiotherapy target volume acceptable by the local radiotherapist\n* Patients enrolled on other clinical trials could be considered after discussion with the chief investigators\n\nExclusion Criteria:\n\n* Patients who underwent a thoracotomy (as large thoracotomy scars may not be adequately covered by this radiotherapy technique)\n* Previous radiotherapy to the region of the chest wall intervention site\n* Indwelling pleural catheter in-situ at the intervention site\n* Patients currently receiving chemotherapy'}, 'identificationModule': {'nctId': 'NCT01604005', 'acronym': 'PIT', 'briefTitle': 'PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma', 'organization': {'class': 'OTHER', 'fullName': 'The Christie NHS Foundation Trust'}, 'officialTitle': 'PIT: A Phase III Randomised Trial of Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma Following Invasive Chest Wall Intervention', 'orgStudyIdInfo': {'id': '08_DOG07_93'}, 'secondaryIdInfos': [{'id': 'ISRCTN04240319', 'type': 'REGISTRY', 'domain': 'ISRCTN'}, {'id': 'PB-PG-1010-23232', 'type': 'OTHER_GRANT', 'domain': 'NIHR Research for Patient Benefit'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PIT Arm', 'interventionNames': ['Radiation: Prophylactic Irradiation of Tracts (PIT)']}, {'type': 'NO_INTERVENTION', 'label': 'No PIT Arm'}], 'interventions': [{'name': 'Prophylactic Irradiation of Tracts (PIT)', 'type': 'RADIATION', 'otherNames': ['Radiation'], 'description': '21 Gy in 3 fractions', 'armGroupLabels': ['PIT Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OL6 9RW', 'city': 'Ashton-under-Lyne', 'country': 'United Kingdom', 'facility': 'Tameside General Hospital', 'geoPoint': {'lat': 53.48876, 'lon': -2.0989}}, {'zip': 'RG24 9NA', 'city': 'Basingstoke', 'country': 'United Kingdom', 'facility': 'Basingstoke & North Hampshire Hospital', 'geoPoint': {'lat': 51.26249, 'lon': -1.08708}}, {'zip': 'CH63 4JY', 'city': 'Bebington', 'country': 'United Kingdom', 'facility': 'Clatterbridge Cancer Centre', 'geoPoint': {'lat': 53.35, 'lon': -3.01667}}, {'zip': 'BT9 7AB', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Belfast City Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'B152TH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'University Hospital Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BB2 3HH', 'city': 'Blackburn', 'country': 'United Kingdom', 'facility': 'Royal Blackburn', 'geoPoint': {'lat': 53.75, 'lon': -2.48333}}, {'zip': 'FY3 8NR', 'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Blackpool Victoria Hospital', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'zip': 'BL4 0JR', 'city': 'Bolton', 'country': 'United Kingdom', 'facility': 'Royal Bolton Hospital', 'geoPoint': {'lat': 53.58333, 'lon': -2.43333}}, {'zip': 'PE21 9QS', 'city': 'Boston', 'country': 'United Kingdom', 'facility': 'Pilgrim Hospital', 'geoPoint': {'lat': 52.97633, 'lon': -0.02664}}, {'zip': 'BD9 6RJ', 'city': 'Bradford', 'country': 'United Kingdom', 'facility': 'Bradford Royal Infirmary', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'zip': 'DE13 0RB', 'city': 'Burton', 'country': 'United Kingdom', 'facility': "Queen's Hospital", 'geoPoint': {'lat': 53.26667, 'lon': -0.56667}}, {'zip': 'CB23 3RE', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Addenbrookes', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CT1 3NG', 'city': 'Canterbury', 'country': 'United Kingdom', 'facility': 'Kent Oncology Centre', 'geoPoint': {'lat': 51.27904, 'lon': 1.07992}}, {'zip': 'TS19 8PE', 'city': 'Cleveland', 'country': 'United Kingdom', 'facility': 'University Hospital of North Tees', 'geoPoint': {'lat': 51.52361, 'lon': -0.32271}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'University Hospital Coventry', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'CW1 4QJ', 'city': 'Crewe', 'country': 'United Kingdom', 'facility': 'Leighton Hospital', 'geoPoint': {'lat': 53.09787, 'lon': -2.44161}}, {'zip': 'DE22 3NE', 'city': 'Derby', 'country': 'United Kingdom', 'facility': 'Royal Derby Hospitals', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'ME7 5NY', 'city': 'Gillingham', 'country': 'United Kingdom', 'facility': 'Medway Maritime Hospital', 'geoPoint': {'lat': 51.38914, 'lon': 0.54863}}, {'zip': 'GU2 7XX', 'city': 'Guildford', 'country': 'United Kingdom', 'facility': 'The Royal Surrey County Hospital', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'CM20 1QX', 'city': 'Harlow', 'country': 'United Kingdom', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': 51.77655, 'lon': 0.11158}}, {'zip': 'HG2 7SX', 'city': 'Harrogate', 'country': 'United Kingdom', 'facility': 'Harrogate District NHS Foundation Trust', 'geoPoint': {'lat': 53.99078, 'lon': -1.5373}}, {'zip': 'HD3 3EA', 'city': 'Huddersfield', 'country': 'United Kingdom', 'facility': 'Calderdale & Hudderfield NHS Trust', 'geoPoint': {'lat': 53.64904, 'lon': -1.78416}}, {'zip': 'IP4 5PD', 'city': 'Ipswich', 'country': 'United Kingdom', 'facility': 'Ipswich Hospital', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}, {'zip': 'PO30 5TG', 'city': 'Isle of Wight', 'country': 'United Kingdom', 'facility': "St Mary's Hospital", 'geoPoint': {'lat': 51.14689, 'lon': 0.39889}}, {'zip': 'DY11 6RJ', 'city': 'Kidderminster', 'country': 'United Kingdom', 'facility': 'Kidderminster General Hospital', 'geoPoint': {'lat': 52.38819, 'lon': -2.25}}, {'zip': 'LA1 4RP', 'city': 'Lancaster', 'country': 'United Kingdom', 'facility': 'University Hospitals of Morecambe Bay NHS Foundation Trust', 'geoPoint': {'lat': 54.04649, 'lon': -2.79988}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'St James University Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'University Hospital of Leicester', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'LN2 5QY', 'city': 'Lincoln', 'country': 'United Kingdom', 'facility': 'United Lincolnshire Hospitals', 'geoPoint': {'lat': 53.22683, 'lon': -0.53792}}, {'zip': 'N18 1QX', 'city': 'London', 'country': 'United Kingdom', 'facility': 'North Middlesex Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SK10 3BL', 'city': 'Macclesfield', 'country': 'United Kingdom', 'facility': 'Macclesfield District General Hospital', 'geoPoint': {'lat': 53.26023, 'lon': -2.12564}}, {'zip': 'ME16 9QQ', 'city': 'Maidstone', 'country': 'United Kingdom', 'facility': 'Maidstone Hospital, Kent Oncology Centre', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'M23 9LT', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Wythenshawe Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'James Cook University Hospital', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'zip': 'HA6 2RN', 'city': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Mount Vernon Cancer Centre', 'geoPoint': {'lat': 51.53174, 'lon': -0.26856}}, {'zip': 'PE30 4ET', 'city': 'Norfolk', 'country': 'United Kingdom', 'facility': 'The Queen Elizabeth hospital'}, {'zip': 'NN1 5BD', 'city': 'Northampton', 'country': 'United Kingdom', 'facility': 'Northampton General Hospital', 'geoPoint': {'lat': 52.25, 'lon': -0.88333}}, {'zip': 'NG17 4JL', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Kings Mill Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'CV10 7DJ', 'city': 'Nuneaton', 'country': 'United Kingdom', 'facility': 'George Eliot Hospital', 'geoPoint': {'lat': 52.52323, 'lon': -1.46523}}, {'zip': 'OL1 2JH', 'city': 'Oldham', 'country': 'United Kingdom', 'facility': 'Royal Oldham Hospital', 'geoPoint': {'lat': 53.54051, 'lon': -2.1183}}, {'zip': 'PE3 9GZ', 'city': 'Peterborough', 'country': 'United Kingdom', 'facility': 'Peterborough City Hospital', 'geoPoint': {'lat': 52.57364, 'lon': -0.24777}}, {'zip': 'BH15 2JB', 'city': 'Poole', 'country': 'United Kingdom', 'facility': 'Dorset Cancer Centre', 'geoPoint': {'lat': 50.71429, 'lon': -1.98458}}, {'zip': 'PR2 9HT', 'city': 'Preston', 'country': 'United Kingdom', 'facility': 'Royal Preston Hospital', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}, {'zip': 'LL18 5UJ', 'city': 'Rhyl', 'country': 'United Kingdom', 'facility': 'Glan Clwyd Hospital', 'geoPoint': {'lat': 53.31929, 'lon': -3.49228}}, {'zip': 'M6 8HD', 'city': 'Salford', 'country': 'United Kingdom', 'facility': 'Salford Royal Hospital', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'zip': 'SP2 8BJ', 'city': 'Salisbury', 'country': 'United Kingdom', 'facility': 'Salisbury District Hospital', 'geoPoint': {'lat': 51.06931, 'lon': -1.79569}}, {'zip': 'S10 2SJ', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Sheffield Teaching Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'ST4 6QG', 'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'facility': 'University Hospital of North Midlands', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}, {'zip': 'CF64 2XX', 'city': 'Vale of Glamorgan', 'country': 'United Kingdom', 'facility': 'Llandough Hospital'}, {'zip': 'WS2 9PS', 'city': 'Walsall', 'country': 'United Kingdom', 'facility': 'Manor Hospital', 'geoPoint': {'lat': 52.58528, 'lon': -1.98396}}, {'zip': 'CV34 5BW', 'city': 'Warwick', 'country': 'United Kingdom', 'facility': 'Warwick Hospital', 'geoPoint': {'lat': 52.28333, 'lon': -1.58333}}, {'zip': 'WN1 2NN', 'city': 'Wigan', 'country': 'United Kingdom', 'facility': 'Wigan & Leigh NHS Foundation Trust', 'geoPoint': {'lat': 53.54296, 'lon': -2.63706}}, {'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'country': 'United Kingdom', 'facility': 'New Cross Hospital', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}, {'zip': 'B98 7UB', 'city': 'Worcestershire', 'country': 'United Kingdom', 'facility': 'Alexandra Hospital'}, {'zip': 'YO31 8HE', 'city': 'York', 'country': 'United Kingdom', 'facility': 'York Teaching Hospital', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}], 'overallOfficials': [{'name': 'Corinne Faivre-Finn', 'role': 'STUDY_CHAIR', 'affiliation': 'The Christie NHS Foundation Trust'}, {'name': 'Neil Bayman', 'role': 'STUDY_CHAIR', 'affiliation': 'The Christie NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brynn Chappell', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Christie NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Trials Project Manager', 'investigatorFullName': 'Brynn Chappell', 'investigatorAffiliation': 'The Christie NHS Foundation Trust'}}}}