Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-04 @ 8:39 AM
Study NCT ID:
NCT03829033
Status:
RECRUITING
Last Update Posted:
2021-09-01
First Post:
2019-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014067', 'term': 'Tonsillar Neoplasms'}], 'ancestors': [{'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2019-02-01', 'studyFirstSubmitQcDate': '2019-02-01', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute side effects.', 'timeFrame': 'From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.', 'description': 'Locoregional side effects (mucositis, pain, dysphagia, skin reactions and other functional impairment) are monitored weekly according to a modified morbidity scoring scale based on Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC). Acute radiation morbidity scoring criteria and other side effects are graded according to (Common Toxicity Criteria for Adverse Events (CTCAE) v4.0'}, {'measure': 'Late side effects.', 'timeFrame': 'At 2-3 months after completed radiotherapy, then every 3 month for 2 years, and then every 6 month until 5 years.', 'description': 'Locoregional side effects (mucositis, pain, dysphagia, skin reactions and other functional impairment) are monitored according to a modified morbidity scoring scale based on Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC). Late radiation morbidity scoring criteria and other side effects are graded according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tonsil Cancer', 'Early Tonsil Cancer', 'Radiotherapy', 'Photons', 'Protons', 'Acute Side Effects', 'Late Side Effects', 'Locoregional Control', 'Disease Free Survival', 'Quality of Life', 'Health Economic'], 'conditions': ['Tonsil Cancer']}, 'descriptionModule': {'briefSummary': 'In this trial, patients with early squamous cell carcinoma of the tonsil with clinical stage T1-2 (p16-positive or p16-negative) N0-1 (p16-positive)/N0-N2b (p16-negative) according to American Joint Committee on Cancer (AJCC) 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent will be included. The patients will be randomized to in a 1:1 ratio to receive radiotherapy with either photons (conventional radiotherapy) versus radiotherapy with protons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient must be at least 18 years old.\n2. Histologically or cytologically confirmed, previously untreated squamous cell carcinoma of the tonsil T1-2 (p16-positive or p16-negative) N0-1 M0 (p16-positive)/N0-N2b M0 (p16-negative) according to AJCC 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent. The treatment may be followed but not preceded by surgery, which would be as a salvage procedure and not part of the planned treatment. An excision of a lymph node, or a tonsillectomy for diagnostic purposes does not exclude the patient from participation.\n3. World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG) performance status 0-1.\n4. The patient must be able to understand the information about the treatment and give a written informed consent.\n\nExclusion Criteria:\n\n1. Patients judged to benefit from bilateral radiotherapy or concomitant chemotherapy\n2. Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with a follow-up time of at least 3 years, or other previous malignancy with a disease-free interval of at least 5 years.\n3. Two or more synchronous primary cancers in the head and neck region at time of diagnosis\n4. Previous surgery or radiotherapy in the head and neck region that may affect the study result, as judged by the investigator\n5. Co-existing disease prejudicing survival (expected survival should be \\>2 years).\n6. Psychiatric or addictive disorders or other medical conditions which in the view of the investigator might impair patient compliance\n7. When dental fillings with amalgam or metal are present close to the tumour area it must be considered if this may affect radiotherapy before inclusion.'}, 'identificationModule': {'nctId': 'NCT03829033', 'acronym': 'ARTSCAN V', 'briefTitle': 'Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Lund University Hospital'}, 'officialTitle': 'Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.', 'orgStudyIdInfo': {'id': 'Version 2 2018-10-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Radiotherapy delivered with photons', 'interventionNames': ['Radiation: Radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Radiotherapy delivered with protons', 'interventionNames': ['Radiation: Radiotherapy']}], 'interventions': [{'name': 'Radiotherapy', 'type': 'RADIATION', 'description': 'Radiotherapy with either photons or protons.', 'armGroupLabels': ['Radiotherapy delivered with photons', 'Radiotherapy delivered with protons']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-803 24', 'city': 'Gävle', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Ann-Sofie Fransson, MD', 'role': 'CONTACT', 'email': 'ann-sofie.fransson@regiongavleborg.se', 'phone': '+46 26 15 40 00'}, {'name': 'Ann-Sofie Fransson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gävle Hospital', 'geoPoint': {'lat': 60.67452, 'lon': 17.14174}}, {'zip': 'SE-413 46', 'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Hedda Haugen, MD', 'role': 'CONTACT', 'email': 'hedda.haugen@oncology.gu.se', 'phone': '+46 31 343 60 42'}, {'name': 'Hedda Haugen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': 'SE-553 05', 'city': 'Jönköping', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Mattias Olin, MD', 'role': 'CONTACT', 'email': 'mattias.olin@rjl.se', 'phone': '+46 10 24 25 942'}, {'name': 'Mattias Olin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jönköping Hospital', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}, {'zip': 'SE-652 30', 'city': 'Karlstad', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Britta Lödén, MD', 'role': 'CONTACT', 'email': 'britta.loden@regionvarmland.se', 'phone': '+46 54 61 50 00'}, {'name': 'Britta Lödén, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Karlstad Hospital', 'geoPoint': {'lat': 59.3793, 'lon': 13.50357}}, {'zip': 'SE-587 50', 'city': 'Linköping', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Anna Flejmer, MD', 'role': 'CONTACT', 'email': 'anna.maria.flejmer@regionostergotland.se', 'phone': '+46 10 103 00 00'}, {'name': 'Anna Flejmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Linköping University Hospital', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': 'SE-221 85', 'city': 'Lund', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Maria Gebre-Medhin, MD', 'role': 'CONTACT', 'email': 'maria.gebre-medhin@skane.se', 'phone': '+46 46 17 75 20'}, {'name': 'Maria Gebre-Medhin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lund University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': 'SE-703 82', 'city': 'Örebro', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Erik Lundin, MD', 'role': 'CONTACT', 'email': 'erik.lundin@regionorebrolan.se', 'phone': '+46 19 602 10 00'}, {'name': 'Erik Lundin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Örebro University Hospital', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'zip': 'SE-171 64', 'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Michael Gubanski, MD', 'role': 'CONTACT', 'email': 'michael.gubanski@sll.se', 'phone': '+46 8 517 700 00'}, {'name': 'Michael Gubanski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'SE-907 37', 'city': 'Umeå', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Björn Zackrisson, MD', 'role': 'CONTACT', 'email': 'bjorn.zackrisson@onkologi.umu.se', 'phone': '+46 90 785 00 00'}, {'name': 'Björn Zackrisson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'zip': 'SE-752 37', 'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Johanna Färlin, MD', 'role': 'CONTACT', 'email': 'johanna.farlin@skandion.se', 'phone': '+46 18 495 80 00'}, {'name': 'Johanna Färlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Scandion clinic', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': 'SE-753 09', 'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Zahra Taheri Kadkhoda, MD', 'role': 'CONTACT', 'email': 'zahra.taheri.kadkhoda@akademiska.se', 'phone': '+46 18 611 00 00'}, {'name': 'Zahra Taheri Kadkhoda, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uppsala Accademical Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': 'SE-723 35', 'city': 'Västerås', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Zizana Lovasova, MD', 'role': 'CONTACT', 'email': 'zuzana.lovasova@regionvastmanland.se', 'phone': '+46 21 17 39 04'}, {'name': 'Zuzana Lovasova, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Västmanlands Hospital', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}], 'centralContacts': [{'name': 'Maria Gebre-Medhin, MD', 'role': 'CONTACT', 'email': 'maria.gebre-medhin@skane.se', 'phone': '+46 46 17 75 20'}, {'name': 'Iréne Schönström, RN', 'role': 'CONTACT', 'email': 'irene.schonstrom@skane.se', 'phone': '+46 46 17 85 59'}], 'overallOfficials': [{'name': 'Maria Gebre-Medhin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University Hospiyal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}