Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-04 @ 9:29 AM
Study NCT ID:
NCT03184350
Status:
UNKNOWN
Last Update Posted:
2017-06-12
First Post:
2017-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Protontherapy of Cervical and Endometrial Carcinomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients will receive a dose of 45-50.4 Gray in 1.8 Gray fractions 5-6 times per week using active raster-scanning pencil beam proton radiation. Platinum-based chemotherapy can be administered if indicated. For treatment planning rectum, sigma, large and small bowel, bladder and femoral heads are defined as organs at risk. The CTV is defined according to the EORTC consensus guidelines. Treatment-associated toxicity and Quality of life will be evaluated regularly.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-09', 'studyFirstSubmitDate': '2017-06-09', 'studyFirstSubmitQcDate': '2017-06-09', 'lastUpdatePostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of acute treatment-associated adverse events ≥ grade 3 [Safety and Tolerability]', 'timeFrame': '3 months', 'description': 'Assessment of toxicity according to the CTC AE v4.0 (Common Toxicity Criteria for adverse events)'}], 'secondaryOutcomes': [{'measure': 'clinical symptoms according to the CTC AE v4.0. criteria', 'timeFrame': '2 years', 'description': 'clinical symptoms of any grade will be assessed'}, {'measure': 'Quality of life of all patients included in the study', 'timeFrame': '2 years', 'description': 'assessed by the EORTC questionnaires QLQ-C30'}, {'measure': 'Quality of life of cervical cancer patients included in the study', 'timeFrame': '2 years', 'description': 'assessed by the EORTC questionnaires QLQ-CX24'}, {'measure': 'Quality of life of endometrial cancer patients included in the study', 'timeFrame': '2 years', 'description': 'assessed by the EORTC questionnaires QLQ-EN24'}, {'measure': 'Progression-free survival', 'timeFrame': '2 years', 'description': 'regular MRI-scans'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical cancer', 'endometrial cancer', 'proton therapy'], 'conditions': ['Uterine Cervical Neoplasms', 'Endometrial Neoplasms Malignant']}, 'referencesModule': {'references': [{'pmid': '36624483', 'type': 'DERIVED', 'citation': 'Meixner E, Wark A, Forster T, Weykamp F, Lang K, Konig L, Lindel K, Oelmann-Avendano JT, Krisam J, Schneeweiss A, Ellerbrock M, Mielke T, Horner-Rieber J, Herfarth K, Debus J, Arians N. Health-related quality of life and patient-reported symptoms after postoperative proton beam radiotherapy of cervical and endometrial cancer: 2-year results of the prospective phase II APROVE-trial. Radiat Oncol. 2023 Jan 9;18(1):5. doi: 10.1186/s13014-023-02198-4.'}, {'pmid': '29179751', 'type': 'DERIVED', 'citation': 'Arians N, Lindel K, Krisam J, Herfarth K, Krug D, Akbaba S, Oelmann-Avendano J, Debus J. Prospective phase-II-study evaluating postoperative radiotherapy of cervical and endometrial cancer patients using protons - the APROVE-trial. Radiat Oncol. 2017 Nov 28;12(1):188. doi: 10.1186/s13014-017-0926-5.'}]}, 'descriptionModule': {'briefSummary': 'The APROVE study is a prospective single-center single-arm phase-II study. Patients with cervical or endometrial cancer after surgical resection who have an indication for postoperative pelvic radiotherapy will be treated with proton therapy instead of the commonly used photon radiation. A total of 25 patients will be included in this trial. Patients will receive a dose of 45-50.4 Gray in 1.8 Gray fractions 5-6 times per week using active raster-scanning pencil beam proton radiation. Platinum-based chemotherapy can be administered if indicated. The primary endpoint of the study is the evaluation of safety and treatment tolerability of pelvic radiation using protons defined as the lack of any CTC AE Grade 3 or 4 toxicity. Secondary endpoints are clinical symptoms and toxicity, quality of life and progression-free survival. The aim is to explore the potential of proton therapy as a new method for adjuvant pelvic radiotherapy to decrease the dose to the bowel, rectum and bladder thus reducing acute and chronic toxicity and improving quality of life.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed cervical or endometrial cancer\n* Indication for postoperative radiotherapy\n* Karnofsky Index ≥ 70\n* Age between 18 and 80 years\n* Written informed consent\n\nExclusion Criteria:\n\n* patient refusal or patient incapable of consent\n* implanted active medical devices with no approval for ion beam radiation\n* metallic implantations in the radiation field like hip prothesis\n* prior pelvic irradiation\n* participation in another clinical trial which might influence the results of the APROVE trial'}, 'identificationModule': {'nctId': 'NCT03184350', 'acronym': 'APROVE', 'briefTitle': 'Adjuvant Protontherapy of Cervical and Endometrial Carcinomas', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Adjuvant Protontherapy of Cervical and Endometrial Carcinomas - A Phase-II-study', 'orgStudyIdInfo': {'id': 'APROVE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Adjuvant pelvic proton radiation', 'interventionNames': ['Radiation: Adjuvant pelvic proton radiation']}], 'interventions': [{'name': 'Adjuvant pelvic proton radiation', 'type': 'RADIATION', 'description': 'Patients will receive a dose of 45-50.4 Gray in 1.8 Gray fractions 5-6 times per week using active raster-scanning pencil beam proton radiation', 'armGroupLabels': ['Adjuvant pelvic proton radiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nathalie Arians, MD', 'role': 'CONTACT', 'email': 'nathalie.arians@med.uni-heidelberg.de', 'phone': '+496221568202'}, {'name': 'Karen Lossner', 'role': 'CONTACT', 'email': 'karen.lossner@med.uni-heidelberg.de', 'phone': '+4962215637748'}], 'facility': 'Department of radiation oncology, University Hospital Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Nathalie Arians, MD', 'role': 'CONTACT', 'email': 'nathalie.arians@med.uni-heidelberg.de', 'phone': '+496221568202'}, {'name': 'Karen Lossner', 'role': 'CONTACT', 'email': 'karen.lossner@med.uni-heidelberg.de', 'phone': '+4962215637748'}], 'overallOfficials': [{'name': 'Juergen Debus, Prof.Dr.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Heidelberg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'senior physician', 'investigatorFullName': 'Nils Nicolay, PD Dr. Dr.', 'investigatorAffiliation': 'Heidelberg University'}}}}