Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-02 @ 1:57 AM
Study NCT ID:
NCT04330456
Status:
RECRUITING
Last Update Posted:
2020-04-01
First Post:
2020-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-31', 'studyFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2020-03-31', 'lastUpdatePostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications', 'timeFrame': '3 year', 'description': 'Rate of complications will be measured after completing each step of protocol: stereotactic radiation therapy, surgery and them postoperative conformal radiation therapy'}], 'secondaryOutcomes': [{'measure': 'Disease-Free survival', 'timeFrame': '3 year', 'description': 'Disease-Free survival will be evaluated after completing the protocol or during the protocol if local recurrence will appear.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Soft Tissue Sarcoma Adult']}, 'descriptionModule': {'briefSummary': 'Combined treatment of soft tissue sarcoma includes 3 steps:\n\n1. step - preoperative stereotactic radiation therapy in hypofractionation mode\n2. step - operation\n3. step - postoperative conformal radiation therapy in normofractionation mode', 'detailedDescription': 'Combined treatment of soft tissue sarcoma includes 3 steps:\n\n1. At the first step patient undergoes preoperative stereotactic radiation therapy in hypofractionation mode. Radiation therapy plan is based on topometric MRI and CT scans. Radiation therapy plan are performed after MRI and CT fusion, contouring of the target and surrounding normal tissues.\n\n At first step only tumor and, if necessary, the surrounding normal tissues, which will be removed during surgery, are exposed to radiation.\n\n GTV - determined in with the boundaries of the tumor visualised by topometric MRI and CT CTV1 - match GTV CTV2 - formed inward (to the tumor center) from GTV by 0.5-1 cm (depending on the proximity of functionally significant normal tissues (neurovascular bundles, bone tissue, skin and subcutaneous fat, etc.) PTV - 3-5 mm indent from CTV1, taking into account the proximity of functionally significant normal tissues and the planned surgery Preoperative radiation therapy is carried in 5 fractions with a single dose on PTV - 5 Gy, a single dose on CTV2 - 7 Gy.\n2. Second step is surgery in 14-21 days.\n3. In 25-35 days after the surgery postoperative conformal radiation therapy is performed according to the standard protocol GTV (tumor bed) - based on the volume of the primary tumor, including the swelling zone (T2-weighted images on preoperative MRI) СTV - formed with an indent of 4 cm from GTV (without going beyond the boundaries of the involved compartment), in the transverse direction the indent could be reduced to 2 cm.\n\nPTV - formed with an indent of 0.5-1cm from CTV An important condition for planning radiation therapy is to limit the dose absorbed during both stages of radiation therapy in surrounding normal tissues that are not removed during surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* morphologically verified diagnosis of soft tissue sarcoma\n* first diagnosed tumor process\n* ability to perform radical surgery\n* signed informed consent\n* indications for stereotactic and conformal radiation therapy\n* no contraindications for radiation and surgical treatment\n\nExclusion Criteria:\n\n* previous radiation treatment\n* acute infection\n* pregnancy, lactation\n* recurrent tumor\n* refuse to sign informed consent\n* conditions that can affect the outcome of treatment (immunodeficiency, tuberculosis, etc.)\n* tumor topography and volume that don't allow to perform stereotactic and conformal radiation therapy."}, 'identificationModule': {'nctId': 'NCT04330456', 'briefTitle': 'Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'N.N. Petrov National Medical Research Center of Oncology'}, 'officialTitle': 'Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy', 'orgStudyIdInfo': {'id': 'SaE in STS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SaE treatment', 'description': 'This group will receive combined treatment of soft tissue sarcoma that include 3 steps:\n\n1. step - preoperative stereotactic radiation therapy in hypofractionation mode (5 fractions 5 Gy each)\n2. step - operation\n3. step - postoperative conformal radiation therapy in normofractionation mode (25 fractions 2 Gy each)', 'interventionNames': ['Radiation: Preoperative stereotactic radiation therapy in hypofractionation mode', 'Procedure: Surgery', 'Radiation: Postoperative conformal radiation therapy in normofractionation mode']}], 'interventions': [{'name': 'Preoperative stereotactic radiation therapy in hypofractionation mode', 'type': 'RADIATION', 'description': 'At the first step patient undergoes preoperative stereotactic radiation therapy in hypofractionation mode. Radiation therapy plan is based on topometric MRI and CT scans. Radiation therapy plan are performed after MRI and CT fusion, contouring of the target and surrounding normal tissues.\n\nAt first step only tumor and, if necessary, the surrounding normal tissues, which will be removed during surgery, are exposed to radiation.\n\nGTV - determined in with the boundaries of the tumor visualised by topometric MRI and CT CTV1 - match GTV CTV2 - formed inward (to the tumor center) from GTV by 0.5-1 cm (depending on the proximity of functionally significant normal tissues (neurovascular bundles, bone tissue, skin and subcutaneous fat, etc.) PTV - 3-5 mm indent from CTV1, taking into account the proximity of functionally significant normal tissues and the planned surgery Preoperative radiation therapy is carried in 5 fractions with a single dose on PTV - 5 Gy, a single dose on CTV2 - 7 Gy.', 'armGroupLabels': ['SaE treatment']}, {'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'In 14-21 days after preoperative stereotactic radiation therapy radical surgery will be performed', 'armGroupLabels': ['SaE treatment']}, {'name': 'Postoperative conformal radiation therapy in normofractionation mode', 'type': 'RADIATION', 'description': 'In 25-35 days after the surgery postoperative conformal radiation therapy is performed according to the standard protocol GTV (tumor bed) - based on the volume of the primary tumor, including the swelling zone (T2-weighted images on preoperative MRI) СTV - formed with an indent of 4 cm from GTV (without going beyond the boundaries of the involved compartment), in the transverse direction the indent could be reduced to 2 cm.\n\nPTV - formed with an indent of 0.5-1cm from CTV An important condition for planning radiation therapy is to limit the dose absorbed during both stages of radiation therapy in surrounding normal tissues that are not removed during surgery.', 'armGroupLabels': ['SaE treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Grigory Zinovev, PhD', 'role': 'CONTACT', 'email': 'zinovevgrigory@gmail.com', 'phone': '+79213405814'}], 'facility': 'National Research Center of Oncology named after N.N.Petrov', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'centralContacts': [{'name': 'Grigory Zinovev, PhD', 'role': 'CONTACT', 'email': 'zinovevgrigory@gmail.com', 'phone': '+79213405814'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'N.N. Petrov National Medical Research Center of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}