Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-04 @ 4:50 PM
Study NCT ID:
NCT01853059
Status:
UNKNOWN
Last Update Posted:
2013-05-15
First Post:
2013-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Outcomes Following Anal Cancer Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001005', 'term': 'Anus Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}], 'ancestors': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 176}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-13', 'studyFirstSubmitDate': '2013-05-10', 'studyFirstSubmitQcDate': '2013-05-10', 'lastUpdatePostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional quality of life after chemoradiotherapy for anal cancer', 'timeFrame': '3 years', 'description': 'Quality of life measured using:\n\nGeneral\n\n* EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30\n\nDisease specific\n\n* EORTC QLQ-CR29\n* Vaizey incontinence score\n* MOS (Medical Outcomes Survey) sexual questionnaire'}], 'secondaryOutcomes': [{'measure': 'Patient-reported treatment-related toxicity after chemoradiotherapy for anal cancer', 'timeFrame': '3 years', 'description': 'Patient-reported treatment related toxicity measured with:\n\n* Common Terminology Criteria for Adverse Events (CTCAE version 3)\n* Pelvis questionnaire male \\& female (LENT/SOMA)\n\n(LENT/SOMA: see Barraclough LH et al. Radiother Oncol; 103:327-32)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anal cancer', 'Squamous cell cancer', 'Radiotherapy', 'Chemoradiotherapy', 'Conformational radiotherapy', 'Intensity modulated radiation therapy', 'IMRT'], 'conditions': ['Anal Cancer']}, 'referencesModule': {'references': [{'pmid': '20492729', 'type': 'BACKGROUND', 'citation': 'Provencher S, Oehler C, Lavertu S, Jolicoeur M, Fortin B, Donath D. Quality of life and tumor control after short split-course chemoradiation for anal canal carcinoma. Radiat Oncol. 2010 May 23;5:41. doi: 10.1186/1748-717X-5-41.'}, {'pmid': '17189954', 'type': 'BACKGROUND', 'citation': 'Brown MW, Brooks JP, Albert PS, Poggi MM. An analysis of erectile function after intensity modulated radiation therapy for localized prostate carcinoma. Prostate Cancer Prostatic Dis. 2007;10(2):189-93. doi: 10.1038/sj.pcan.4500938. Epub 2006 Dec 26.'}, {'pmid': '22633812', 'type': 'BACKGROUND', 'citation': 'Barraclough LH, Routledge JA, Farnell DJ, Burns MP, Swindell R, Livsey JE, Davidson SE. Prospective analysis of patient-reported late toxicity following pelvic radiotherapy for gynaecological cancer. Radiother Oncol. 2012 Jun;103(3):327-32. doi: 10.1016/j.radonc.2012.04.018. Epub 2012 May 23.'}]}, 'descriptionModule': {'briefSummary': "Anal cancer is treated with chemoradiotherapy- combined chemotherapy and radiotherapy. This is very successful (75% long term survival). During the course of the radiotherapy, other organs in the pelvis may be damaged. This can lead to long-term problems with possible changes to the skin, bowels with diarrhoea and incontinence problems, bladder shrinkage and incontinence of urine, sexual problems including impotence and ejaculatory problems, or pain during sexual intercourse with vaginal dryness and shrinkage. Patients should be offered help with these side effects. At present, there is very little information on the effect treatment has on a patient's quality of life, making it difficult to judge if new treatment methods are better.\n\nThis project will measure quality of life from the patient's perspective after treatment for anal cancer. It will also gather preliminary data on quality of life after the introduction of a new technique for more precise 3D-targeting of radiotherapy beams at the cancer, called IMRT."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients under the care of the anal cancer multidisciplinary team in Addenbrookes, Cambridge and Christie Hospital, Manchester', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Male or Female, aged 18 years or above.\n* Squamous cell or basaloid carcinoma of the anal canal\n\nExclusion Criteria:\n\n* adenocarcinoma, melanoma, lymphoma, sarcoma or other malignancy of anal canal\n* Any synchronous or metanchronous pelvic malignancy of non-anal origin (eg. prostatic, genital tract)\n* unable to complete questionnaire'}, 'identificationModule': {'nctId': 'NCT01853059', 'acronym': 'FOFACT', 'briefTitle': 'Functional Outcomes Following Anal Cancer Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Observational Study of Functional Outcomes After Chemoradiotherapy for Squamous Cell Cancer of the Anus', 'orgStudyIdInfo': {'id': 'A092896'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IMRT', 'description': 'Prospective longitudinal assessment of patients receiving intensity-modulated radiation therapy for anal cancer'}, {'label': 'Conventional', 'description': 'Cross-sectional analysis of patients receiving conventional radiotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'contacts': [{'name': 'Adam T Stearns', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicola Fearnhead', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Charles Wilson', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Catherine Jephcott', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Justin Davies', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Addenbrookes Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'contacts': [{'name': 'Andrew Renehan', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Susan Davidson', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mark Saunders', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Christie Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Adam Stearns, MA DPhil BMBCh MRCS', 'role': 'CONTACT', 'phone': '01603286286'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Christie NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Bowel Disease Research Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist Registrar in Surgery', 'investigatorFullName': 'Adam Stearns', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}