Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT05203120
Status:
RECRUITING
Last Update Posted:
2023-05-11
First Post:
2021-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061766', 'term': 'Proton Therapy'}], 'ancestors': [{'id': 'D063193', 'term': 'Heavy Ion Radiotherapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'National phase II non-randomized single-arm study of proton therapy in patients with hepatocellular carcinoma.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2021-12-13', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of deaths of any cause', 'timeFrame': '4 months after start of radiotherapy', 'description': 'Death of any cause'}, {'measure': 'Number of participants with Radiation-induced liver disease (RILD)', 'timeFrame': '4 months after start of radiotherapy', 'description': 'Worsening of the Child- Pugh score ≥2 or alanin-aminotransferase (ALAT) ≥5 upper normal limit (ULN)'}], 'secondaryOutcomes': [{'measure': 'Number of participants with RILD within 6 months of start of radiotherapy', 'timeFrame': '6 months after start of radiotherapy', 'description': 'Worsening of the Child- Pugh score ≥2 or ALAT ≥5 ULN'}, {'measure': 'Acute toxicity', 'timeFrame': '4 months after start of radiotherapy', 'description': 'Number of participants with Acute radiation-related toxicity grade 3 or higher measured by CTCAE v5.0'}, {'measure': 'Late toxicity', 'timeFrame': 'from 4 months until 60 months after start of radiotherapy', 'description': 'Number of participants with Late radiation-related toxicity grade 3 or higher measured by CTCAE v5.0'}, {'measure': 'Radiation-induced hospitalization', 'timeFrame': 'within 4 months after start of radiotherapy', 'description': 'Number of days spend in the hospital due to radiotherapy toxicity'}, {'measure': 'Health-related Quality of Life C30', 'timeFrame': 'Until 60 months after start of radiotherapy', 'description': 'Health-related Quality of life measured by the EORTC QoL questionnaires C30'}, {'measure': 'Quality of Life HCC-18', 'timeFrame': 'Until 60 months after start of radiotherapy', 'description': 'Health-related Quality of life measured by the EORTC QoL questionnaires HCC18'}, {'measure': 'Local control', 'timeFrame': '3 years after start of radiotherapy', 'description': '1- and 3-year local control'}, {'measure': 'Progression-free survival', 'timeFrame': '3 years after start of radiotherapy', 'description': '1- and 3-year progression-free survival'}, {'measure': 'Overall survival', 'timeFrame': '3 years after start of radiotherapy', 'description': '1- and 3-year overall survival'}, {'measure': 'Pattern of failure', 'timeFrame': 'Until 5 years after start of radiotherapy', 'description': 'Pattern of failure will be reported as number of patients with in-field failures in the clinical target volumen (CTV), in-field failures in the planning target volume (PTV), and out-of-field failures.'}, {'measure': 'Technical feasibility', 'timeFrame': 'up to 5 years', 'description': 'the proportion of patients where it was possible to adhere to the guidelines of CTV dose coverage and tolerable normal tissue dose'}, {'measure': 'Reduction in mean liver dose', 'timeFrame': 'up to 5 years', 'description': 'calculated on a per patient basis, and median (and inter-quartile ranged) will be reported for the study population.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': '350 new cases of hepatocellular carcinoma (HCC) are diagnosed in Denmark each year, but the overall prognosis is poor with a 1-year survival rate of less than 40% and a 5-year survival rate of 10% for the entire patient group.\n\nThis national phase II non-randomized single-arm study of proton therapy in HCC is conducted with the aim to offer a safe and efficient radiation treatment to fragile patients with reduced dose to the normal liver compared to conventional photon-based radiotherapy.', 'detailedDescription': 'Each year, approximately 350 new cases of hepatocellular carcinoma (HCC) are diagnosed in Denmark, but the overall prognosis is poor with a 1-year survival rate of less than 40% and a 5-year survival rate of 10% for the entire patient group.\n\nThis national phase II non-randomized single-arm study of proton therapy in HCC is conducted with the aim to offer a safe and efficient radiation treatment to fragile patients with reduced dose to the normal liver compared to conventional photon-based radiotherapy. The study aims to offer curative treatment to a larger group of patients and thus better prognosis for these patients.\n\nThe study will include 50 patients enrolled within 3 years. Patients cannot be guaranteed any direct personal benefits of participating in the trial. Participating in the study can help with new knowledge that can benefit future patients with similar illness.\n\nThe treatment will be given at the Danish Center for Particle Therapy. During radiotherapy, additional CT scans will be performed weekly as part of quality assurance until it can be documented that there is no such need.\n\nParticipation in the study will also mean additional examinations and questionnaires at the start of treatment, below treatment and at follow-up.\n\nAll patients will be asked to supply blood samples to analyze for circulating tumor DNA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with HCC based on classical radiologic findings as defined by the American Association for the Study of Liver Diseases (AASLD) criteria or verified by biopsy\n* No extra-hepatic disease\n* Deemed ineligible for resection or Radiofrequency Ablation (RFA), or the patients should refuse RFA or surgery\n* Age ≥ 18 years\n* Performance status ≤ 2\n* Total diameter of tumor(s) ≤ 12 cm and a maximum of 3 tumors\n* Adequate liver function as measured by Child-Pugh score (Child-Pugh score ≤ 8), or absence of cirrhosis\n* Has recovered adequately from toxicity and/or complications from any previous local interventions\n* Patients with past or ongoing hepatitis C infection are allowed, but treatment for hepatitis C must have been completed one month before study entry\n* Patients with hepatitis B infection is allowed if antiviral therapy have been given for at least 4 weeks and Hepatitis B Virus (HBV) viral load is less than 100 IU/ml. The active therapy must continue throughout the radiation therapy. Patients who are Total hepatitis B core antibody (anti-HBc)(+), negative for Hepatitis B surface antigen (HbsAg) and negative or positive for Hepatitis B surface antibody (anti-HBs) with a HBV viral load under 100 IU/mL do not require HBV anti-viral prophylaxis\n* Adequate organ function\n\n * hematological: hemoglobin ≥ 6 mmol/l, absolute neutrophil count (ANC) ≥ 1,5 x 109/L, platelets ≥ 50 x 109/L\n * hepatic: bilirubin ≤ 1.5 x ULN, alanin-aminotransferase (ALAT) ≤ 1.5 x ULN\n * renal: creatinine ≤ 1.5 x ULN\n* Ability to adhere to procedures for study and follow-up\n* Signed informed consent to participate\n* Final decisions on inclusion and treatment with proton therapy are at the discretion of the investigator\n\nExclusion Criteria:\n\n* Previous x-ray-based radiotherapy in the liver\n* Child Pugh score \\>8\n* Tumor less than 1 cm from any critical organs at risk (OAR) (duodenum, kidney, stomach, intestines).\n* Previous Selective internal radiation therapy (SIRT)\n* Episode of hepatic encephalopathy within the last 6 months\n* Uncontrolled ascites with need for drainage \\> 1 per month\n* Episode of bleeding esophageal varices within the past month. If active bleeding from esophageal varices has occurred, a gastroscopy should be performed 4 weeks after the bleeding episode to ensure maximum grade 1 varices.\n* Patients with metal implants where beam entrance through the metal implants cannot be avoided (not applicable for fiducial markers implanted for radiotherapy use)\n* Patients for whom it is not possible to produce a robust treatment plan following the technical guidelines (Appendix A)\n* Patients for whom it is not possible to implant fiducial markers e.g. due to insufficient coagulation of the blood.'}, 'identificationModule': {'nctId': 'NCT05203120', 'briefTitle': 'A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'DCPT HCC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proton Arm', 'description': 'All patients in the study will receive proton therapy with 67.5 Gray/15 fractions(fx) /5fx per week .', 'interventionNames': ['Radiation: Proton therapy']}], 'interventions': [{'name': 'Proton therapy', 'type': 'RADIATION', 'description': 'All patients will receive proton therapy 67.5Gy/15fx', 'armGroupLabels': ['Proton Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'state': 'Capital Region', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mette van Overeem Felter, MD', 'role': 'CONTACT', 'email': 'mette.van.overeem.felter@regionh.dk'}, {'name': 'Kirsten Vistisen, MD', 'role': 'CONTACT', 'email': 'Kirsten.Vistisen@regionh.dk'}], 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '8200', 'city': 'Aarhus', 'state': 'Central Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Britta Weber, MD PhD', 'role': 'CONTACT', 'email': 'britta.weber@auh.rm.dk', 'phone': '+45 26236694'}, {'name': 'Hanna R Mortensen, Md PhD', 'role': 'CONTACT', 'email': 'hanna.mortensen@auh.rm.dk', 'phone': '+45 92432382'}, {'name': 'Hanna R Mortensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Britta Weber, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Morten Høyer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gerda E Villadsen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Peter Jepsen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Esben Worm', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elizaveta Tabeksblat, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '5000', 'city': 'Odense', 'state': 'Syd', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Merete Krogh', 'role': 'CONTACT', 'email': 'Merete.Krogh@rsyd.dk'}, {'name': 'Annette Fialla', 'role': 'CONTACT'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Britta Weber, MD PhD', 'role': 'CONTACT', 'email': 'britta.weber@auh.rm.dk', 'phone': '+4526236694'}, {'name': 'Hanna R Mortensen, MD PhD', 'role': 'CONTACT', 'email': 'hanna.mortensen@auh.rm.dk', 'phone': '+45 92432382'}], 'overallOfficials': [{'name': 'Britta Weber, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Center of Particle Therapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Herlev Hospital', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'University of Leeds', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}