Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
Study NCT ID:
NCT06022159
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2023-08-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Radiation therapy followed by surgery'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2023-08-16', 'studyFirstSubmitQcDate': '2023-08-28', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The rate of patients free of major surgical complications as defined by O'Sullivan within 6 months of surgery.", 'timeFrame': '6 month for each patient'}], 'secondaryOutcomes': [{'measure': "Patients' disease-free survival defined as the time between the inclusion date and the occurrence of a carcinological event (local recurrence, distant metastasis) or death from any cause.", 'timeFrame': '3 years for each patient'}, {'measure': 'Surgical complications evaluated according to NCI CTC AE V5 criteria.', 'timeFrame': '3 years for each patient'}, {'measure': 'Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent.', 'timeFrame': '3 years for each patient'}, {'measure': 'Healing time defined as the time between the date of surgery and the date of complete healing.', 'timeFrame': '3 years for each patient'}, {'measure': "Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30).", 'timeFrame': '3 years for each patient'}, {'measure': "Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14).", 'timeFrame': '3 years for each patient'}, {'measure': 'Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire.', 'timeFrame': '3 years for each patient'}, {'measure': 'Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire.', 'timeFrame': '3 years for each patient'}, {'measure': 'Geriatric parameters evaluated using the G-CODE questionnaire.', 'timeFrame': '3 years for each patient'}, {'measure': 'Toxicities of the radiation therapy evaluated according to NCI CTC AE V5 criteria and Radiation Therapy Oncology Group (RTOG) classification.', 'timeFrame': '3 years for each patient'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Soft Tissue Sarcoma', 'Limb soft tissue SARComa', 'Trunk soft tissue SARComa', 'Aged population', '"Fragile" population', 'hypofractionated radiation therapy'], 'conditions': ['Soft Tissue Sarcoma']}, 'descriptionModule': {'briefSummary': 'This is a phase II, multicenter, non-randomized study.\n\nThe main objective is to evaluate the treatment with hypofractionated radiation therapy in neo-adjuvant situations on wound healing in a population of aged patients (≥ 70 years old) or ≥ 65 years of age defined as "fragile" and treated for soft tissue sarcoma.\n\nA maximum of 48 evaluable patients will be included in this study. The patients will receive an hypofractionated radiation therapy prior to conservative surgery.\n\nEach patient will be followed for up to 3 years after the end of complete treatment (radiotherapy + surgery).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient with histologically confirmed soft tissue sarcoma of the limbs or trunk.\n2. Indication for neo-adjuvant or adjuvant radiotherapy.\n3. Patient aged ≥ 70 years with a performance status ECOG ≤ 2 and/or aged 65 to 70 years with an ECOG of 2 and identified by the investigator as "fragile".\n4. Patient affiliated to a Social Health Insurance in France.\n5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures.\n\nExclusion Criteria:\n\n1. Retroperitoneal, ORL and visceral sarcomas.\n2. Previous radiotherapy in the area.\n3. Metastatic disease.\n4. Concomitant or sequential chemotherapy.\n5. Patient requiring total surgery (amputation).\n6. Other cancer under treatment.\n7. Any condition or pathology contraindicating MRI.\n8. Any psychological, familial, geographic or social situation, potentially preventing the provision of informed consent or compliance to study procedure.\n9. Patients included in another therapeutic interventional trial.\n10. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).'}, 'identificationModule': {'nctId': 'NCT06022159', 'acronym': 'HYPOSARC', 'briefTitle': 'A Study to Evaluate Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.', 'organization': {'class': 'OTHER', 'fullName': 'Institut Claudius Regaud'}, 'officialTitle': 'Phase II Study Evaluating Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.', 'orgStudyIdInfo': {'id': '23 SARC 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiation therapy followed by surgery', 'interventionNames': ['Radiation: Hypofractionated Radiation Therapy', 'Procedure: Conservative treatment']}], 'interventions': [{'name': 'Hypofractionated Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Intensity-modulated radiation therapy (IMRT)'], 'description': 'The Hypofractionated Intensity-Modulated Radiation Therapy will be delivered in 5 fractions of 6 Gy each on the Planning Target Volume (PTV). The total dose of 30 Gy will be administered in approximately 1 week.', 'armGroupLabels': ['Radiation therapy followed by surgery']}, {'name': 'Conservative treatment', 'type': 'PROCEDURE', 'description': 'A wide en bloc resection is required (amputation is excluded) while ensuring the best functional preservation. The surgical procedure will take place about 1,5 to 2 months after the end of the radiation therapy.', 'armGroupLabels': ['Radiation therapy followed by surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pauline GILLON', 'role': 'CONTACT', 'email': 'p.gillon@bordeaux.unicancer.fr', 'phone': '05 56 33 33 43'}], 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Abel CORDOBA LARGO', 'role': 'CONTACT', 'email': 'a-cordoba@o-lambret.fr', 'phone': '03 20 29 59 59'}], 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hélène ORLIAC', 'role': 'CONTACT', 'email': 'helene.orliac@chu-limoges.fr', 'phone': '05 55 05 62 68'}], 'facility': 'Chu de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Waisse WAISSI', 'role': 'CONTACT', 'email': 'waisse.waissi@lyon.unicancer.fr', 'phone': '04 78 78 28 28'}], 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Carmen LLACER-MOSCARDO', 'role': 'CONTACT', 'email': 'carmen.llacer@icm.unicancer.fr', 'phone': '04 67 61 37 79'}], 'facility': 'Institut Regional Du Cancer de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvie HELFRE', 'role': 'CONTACT', 'email': 'sylvie.helfre@curie.net', 'phone': '01 44 32 46 25'}], 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sarah GARCIA MOLINA', 'role': 'CONTACT', 'email': 'sarah.garcia-molina@chu-poitiers.fr', 'phone': '05 49 44 44 44'}], 'facility': 'Chu de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Saint-Herblain', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Augustin MERVOYER', 'role': 'CONTACT', 'email': 'augustin.mervoyer@ico.unicancer.fr', 'phone': '02 40 67 99 00'}], 'facility': "Institut de Cancerologie de L'Ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Louis COURTOT', 'role': 'CONTACT', 'email': 'courtot.l@chu-toulouse.fr', 'phone': '05 61 77 21 04'}], 'facility': 'Chu de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Justine ATTAL KHALIFA', 'role': 'CONTACT', 'email': 'attalkhalifa.justine@iuct-oncopole.fr', 'phone': '05 31 15 54 38'}], 'facility': 'IUCT-O', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cécile LE PECHOUX', 'role': 'CONTACT', 'email': 'cecile.lepechoux@gustaveroussy.fr', 'phone': '01 42 11 42 11'}], 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Justine ATTAL KHALIFA', 'role': 'CONTACT', 'email': 'AttalKhalifa.Justine@iuct-oncopole.fr', 'phone': '05 31 15 54 38'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Claudius Regaud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}