Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-30 @ 4:34 AM
Study NCT ID:
NCT06831903
Status:
RECRUITING
Last Update Posted:
2025-02-18
First Post:
2025-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiotherapy of Head and Neck Cancer With SIB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2039-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2025-01-03', 'studyFirstSubmitQcDate': '2025-02-12', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local control rate.', 'timeFrame': 'From the date of treatment initiation until local recurrence or last follow-up, whichever occurs first, assessed up to 60 months.', 'description': 'Key aspects of local tumor control include:\n\nNo Evidence of Tumor Growth:\n\nThe absence of measurable or observable increase in the size of the tumor at the primary site.\n\nTumor Response to Treatment:\n\nComplete Response (CR): Disappearance of all signs of cancer at the primary site.\n\nPartial Response (PR): Reduction in tumor size without complete disappearance.\n\nPersistence of Stable Disease:\n\nThe tumor remains unchanged in size and does not spread locally beyond the treated area.\n\nTime Frame: 5 years from treatment start.\n\nAssessment Methods:\n\nClinical Examination: Evaluation of the treated site for physical signs of recurrence.\n\nImaging Techniques: CT, MRI, or PET scans to detect residual or recurrent disease.\n\nBiopsy: When clinically indicated, to confirm recurrence if suspected.'}, {'measure': 'Regional tumor control rate', 'timeFrame': 'From the date of treatment initiation until regional recurrence or last follow-up, whichever occurs first, assessed up to 60 months.', 'description': 'Key aspects of regional tumor control include:\n\nAbsence of Disease Progression:\n\nNo enlargement, growth, or new involvement of lymph nodes in the regional drainage area.\n\nResponse to Treatment:\n\nComplete Response (CR): All detectable cancer in the regional lymph nodes has disappeared.\n\nPartial Response (PR): A significant reduction in the size of affected lymph nodes or nodal masses.\n\nStable Disease:\n\nThe size and characteristics of the regional lymph nodes remain unchanged after treatment, without evidence of further spread.\n\nTime Frame: 5 years\n\nAssessment Methods:\n\nImaging: CT, MRI, or PET scans are used to assess lymph node involvement and detect residual or recurrent disease.\n\nPhysical Examination: Palpation or clinical inspection for lymph node abnormalities.\n\nBiopsy or Fine Needle Aspiration: To confirm suspected recurrence or residual'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of treatment initiation until death from any cause or last follow-up, whichever occurs first, assessed up to 60 months.', 'description': 'Overall Survival (OS) is a clinical endpoint that refers to the length of time from the start of treatment (or diagnosis, depending on the study design) until death from any cause.\n\nKey Aspects of Overall Survival:\n\nInclusion of All Causes of Death:\n\nOS accounts for death from cancer, treatment-related complications, or any other unrelated causes (e.g., accidents or comorbid conditions).\n\nMeasurement:\n\nOS as a median survival time (e.g., the time by which 50% of patients are still alive) and as a survival rate at specific time intervals (e.g., 1-year, 3 Year, 5-year OS rates).\n\nTime Frame:\n\nThe starting point for measuring OS is the date of treatment initiation, The endpoint is the date of death or the last follow-up for patients who are still alive (censored data).\n\nAssessment Methods:\n\nOS is determined using survival analysis techniques, (Kaplan-Meier estimates), to calculate survival probabilities and generate survival curves.'}, {'measure': 'Disease-Specific Survival (DSS)', 'timeFrame': 'From the date of treatment initiation until disease-specific death or last follow-up, whichever occurs first, assessed up to 60 months.', 'description': 'Disease-Specific Survival (DSS) refers to the length of time from the start of treatment (or diagnosis, depending on the study design) until death specifically caused by the disease being studied, excluding deaths from other causes.\n\nKey Aspects of Disease-Specific Survival:\n\nFocus on Disease-Related Deaths:\n\nOnly deaths directly attributable to the disease (e.g., cancer progression, metastasis) are considered in DSS calculations.\n\nDeaths from unrelated causes, such as accidents, other illnesses, or age-related factors, are excluded.\n\nMeasurement:\n\nDSS is expressed as the time from treatment initiation to disease-specific death, or as a survival rate at specific intervals (e.g., 1,3,5-year DSS rate).\n\nTime Frame:\n\nThe starting point for DSS measurement is the date of the start of treatment. The endpoint is the date of disease-specific death or last follow-up (for censored cases).\n\nAssessment Methods:\n\nDSS is determined using survival analysis techniques (Kaplan-Meier curves).'}, {'measure': 'Metastasis-Free Survival (MFS)', 'timeFrame': 'From the date of treatment initiation until the first occurrence of distant metastasis, death from any cause, or last follow-up, whichever occurs first, assessed up to 60 months.', 'description': 'MFS refers to the length of time from the start of treatment (or diagnosis, depending on the study design) until the first occurrence of distant metastasis (cancer spreading to distant organs or tissues) or death from any cause, whichever comes first. It is a commonly used endpoint in oncology studies to evaluate the effectiveness of treatments in preventing the spread of cancer.\n\nInclusion Criteria:\n\nPatients are considered metastasis-free as long as there is no evidence of cancer spreading beyond the primary site and regional lymph nodes.\n\nEvents Considered:\n\nDevelopment of distant metastases (e.g. cancer in the lungs, liver, bones, or other remote organs).\n\nDeath from any cause will be included in MFS, making it a composite endpoint.\n\nMeasurement:\n\nMFS is expressed as the time from diagnosis or treatment initiation to the occurrence of distant metastasis or death. For patients who remain alive and free of metastases at the end of follow up the data are censored at the last FU.'}, {'measure': 'Secondary malignancies', 'timeFrame': 'From Enrollment to the 5 years after the end of treatment.', 'description': 'Incidence of secondary malignancies'}, {'measure': 'Toxicities', 'timeFrame': 'From the date of enrollment until the occurrence of acute or late therapy-related toxicities, death, or last follow-up, whichever occurs first, assessed up to 60 months.', 'description': 'Acute and late therapy-related toxicities (CTC AE scale).'}, {'measure': 'General quality of life (EORTC QLQ-30)', 'timeFrame': 'Enrollment, end of radiotherapy (week 7 from start), week 6-8 after the end of radiotherapy, 12, 24, 36, 48, 60 Month after the end of radiotherapy or death from any cause, or last follow-up, whichever occurs first.', 'description': 'The EORTC QLQ-C30 is a validated tool comprising 30 items grouped into functional scales (e.g., physical, emotional, and social functioning), symptom scales (e.g., fatigue, nausea, and pain), and global health status/QoL. Scores for each scale range from 0 to 100. Higher scores on functional and global health/QoL scales indicate better outcomes, whereas higher scores on symptom scales represent worse outcomes.'}, {'measure': 'Organ specific quality of life (EORTC QLQ-H&N35)', 'timeFrame': 'Enrollment, end of radiotherapy (week 7 from start), week 6-8 after the end of radiotherapy, 12, 24, 36, 48, 60 Month after the end of radiotherapy or death from any cause, or last follow-up, whichever occurs first.', 'description': 'EORTC QLQ-H\\&N35 quest, specifically tailored for head and neck cancer patients, captures detailed information on a wide range of symptoms and treatment-related toxicities, including but not limited to:\n\nDysphagia (difficulty swallowing);Speech problems (articulation and clarity); Xerostomia (dry mouth) Sticky saliva Altered taste and smell Hearing loss Pain in the mouth, throat or jaw Soreness or discomfort in the treated area Breathing difficulties Nasal congestion or discharge Difficulty eating or maintaining weight Nutritional supplementation requirements Body image concerns Social functioning and isolation Financial burden associated with treatment Skin reactions in the irradiated area Fatigue and general physical discomfort Scores for each scale range from 0 to 100. Higher scores on symptom scales indicate worse outcomes (e.g. more pain, worse swallowing), while higher scores on functional scales suggest better outcomes(e.g. improved ability to swallow or speak).'}, {'measure': 'Factors Influencing Recurrence Patterns', 'timeFrame': 'From treatment start until first evident recurrence. Censoring for all patients without recurrence at 5 Years.', 'description': 'Factors Influencing Recurrence Patterns:\n\nTumor-Specific Factors:\n\nTumor stage and size (T and N classification). Histological subtype and grade. Human papillomavirus (HPV) status: HPV-positive tumors typically have better local and regional control but can still metastasize.\n\nTreatment-Related Factors:\n\nDose and technique of radiotherapy: Modern techniques like IMRT/VMAT with simultaneous integrated boost (SIB) can reduce local recurrence by improving dose conformity.\n\nUse of concurrent chemotherapy: Enhances radiosensitivity and reduces recurrence risk, especially in advanced-stage disease.\n\nAdherence to treatment protocols.\n\nPatient-Specific Factors:\n\nSmoking and alcohol use post-treatment. Comorbidities that impact treatment tolerance and immune response. Nutritional and functional status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality of Life (QOL)', 'Head and Neck Cancer', 'Radiotherapy Side Effect', 'Radiotherapy, Conformal (IMRT)']}, 'descriptionModule': {'briefSummary': 'Title: Simultaneous Integrated Boost in Primary and Adjuvant Therapy of Head and Neck Tumors: Quality Control Registry Prospective Longitudinal Observational Study\n\nShort Title: Radiotherapy for Head and Neck Tumors with SIB\n\nObjective: To evaluate the efficacy and safety of definitive and adjuvant radio(chemo)therapy with simultaneous integrated boost (SIB) in patients with head and neck cancers. The study aims to assess local and regional control, overall survival, metastasis-free survival, therapy-related toxicities, and quality of life.\n\nStudy Design: A prospective, longitudinal, non-interventional registry study documenting real-world outcomes and quality measures of therapy applied according to existing clinical guidelines.', 'detailedDescription': 'This study is a prospective, longitudinal, non-interventional quality control registry focused on the application of simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) in the primary and adjuvant treatment of head and neck cancers. The primary objectives are to evaluate local and regional control rates, overall survival, tumor-specific survival, and metastasis-free survival. The study also aims to document acute and late treatment-associated toxicities, patient-reported quality of life, and recurrence patterns in relation to delivered radiation doses.\n\nPatients with histologically confirmed malignancies of the head and neck region (excluding basal cell carcinoma) who are indicated for definitive or adjuvant radiotherapy or radiochemotherapy will be included. Treatment planning involves individualized IMRT/VMAT-based approaches with SIB techniques designed to escalate doses to high-risk tumor regions while sparing surrounding healthy structures, thereby reducing toxicity. The treatment is provided in compliance with national guidelines and inter-disciplinary tumor board recommendations.\n\nEvaluation of Adverse Events The study employs the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires-QLQ-C30 and H\\&N35-to systematically assess treatment-related adverse events (AEs) and their impact on quality of life. These standardized tools are administered at baseline, at the end of treatment, and during follow-up visits.\n\nThe EORTC QLQ-H\\&N35 questionnaire, specifically tailored for head and neck cancer patients, captures detailed information on a wide range of symptoms and treatment-related toxicities, including but not limited to:\n\nSwallowing and Oral Function:\n\nDysphagia (difficulty swallowing) Speech problems (articulation and clarity) Xerostomia (dry mouth) Sticky saliva\n\nSensory Impairments:\n\nAltered taste and smell Hearing loss\n\nPain and Discomfort:\n\nPain in the mouth, throat, or jaw Soreness or discomfort in the treated area\n\nRespiratory Symptoms:\n\nBreathing difficulties Nasal congestion or discharge\n\nNutritional Challenges:\n\nDifficulty eating or maintaining weight Nutritional supplementation requirements\n\nEmotional and Social Impact:\n\nBody image concerns Social functioning and isolation Financial burden associated with treatment\n\nOther Common Toxicities:\n\nSkin reactions in the irradiated area Fatigue and general physical discomfort These adverse events are graded using the Common Terminology Criteria for Adverse Events (CTCAE), enabling consistent reporting of the severity and frequency of toxicities.\n\nData Collection and Statistical Analysis The collected data will include baseline patient characteristics, treatment parameters, and longitudinal quality-of-life scores. Outcomes will be analyzed to identify correlations between reported toxicities, dosimetric parameters, and clinical outcomes, such as recurrence patterns and survival metrics.\n\nThe statistical methodology includes:\n\nDescriptive statistics for baseline demographics and treatment variables. Kaplan-Meier estimates for survival analysis. Cox proportional hazards models to explore the influence of clinical and treatment-related factors on survival and recurrence.\n\nCorrelation analyses to assess the relationship between dosimetric variables and recurrence patterns.\n\nSignificance of the Study This study seeks to complement clinical trial data with real-world evidence on the implementation of SIB-IMRT in head and neck cancer treatment. By systematically capturing and analyzing treatment-related toxicities and quality-of-life metrics, the findings aim to refine therapeutic protocols, enhance patient outcomes, and inform strategies to mitigate adverse events. Moreover, the integration of recurrence pattern analysis and ontogenetic lymphatic mapping could offer valuable insights for future treatment planning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 and older with histologically confirmed malignant head and neck tumors, undergoing definitive or adjuvant radio(chemo)therapy at the University Hospital Würzburg between October 2019 and October 2034', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 and older with histologically confirmed malignant head and neck tumors, undergoing definitive or adjuvant radio(chemo)therapy at the University Hospital Würzburg\n\nExclusion Criteria:\n\n* missing informed consent\n* mental or physical disorders leading to inability to understand and/or fill the quationary\n* judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures'}, 'identificationModule': {'nctId': 'NCT06831903', 'briefTitle': 'Radiotherapy of Head and Neck Cancer With SIB', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'Simultaneous Integrated Boost in the Primary and Adjuvant Therapy of Head and Neck Cancer: Quality Control Registry Prospective Longitudinal Obervation Trial', 'orgStudyIdInfo': {'id': '159/16-sc'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Head and neck radio(chemo)therapy', 'description': 'Patients aged 18 and older with histologically confirmed malignant head and neck tumors, undergoing definitive or adjuvant radio(chemo)therapy at the University Hospital Würzburg between October 2019 and October 2034.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97080', 'city': 'Würzburg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Victor Lewitzki, PhD', 'role': 'CONTACT', 'email': 'lewitzki_v@ukw.de', 'phone': '+4993120128869'}, {'name': 'Vanessa Sterk', 'role': 'CONTACT', 'email': 'sterk_v@ukw.de', 'phone': '+4993120128178'}, {'name': 'Lewitzki Victor, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lawrenz Ingulf, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kempa Sebastian, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Clinic of Wuerzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'centralContacts': [{'name': 'Victor Lewitzki, MD, PhD', 'role': 'CONTACT', 'email': 'lewitzki_v@ukw.de', 'phone': '+49-931-201-28869'}, {'name': 'Sterk Vanessa', 'role': 'CONTACT', 'email': 'sterk_v@ukw.de', 'phone': '+49-931-201-28180'}], 'overallOfficials': [{'name': 'Victor Lewitzki, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinic of Wuerzburg, Department of Radiation Oncology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Individual participant data (IPD) will not be shared publicly due to privacy concerns and ethical considerations. The study ensures strict compliance with data protection regulations, including the anonymization of data stored in a secure, password-protected system within the University Hospital Würzburg's internal network. The sensitive nature of the data, combined with its use for internal quality assurance and prospective analysis, limits its availability for external distribution. Findings and aggregated results will be shared through peer-reviewed publications and presentations, ensuring patient confidentiality is maintained."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}