Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 7:08 AM
Study NCT ID:
NCT05167994
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2021-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma （SPARE-01）
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2021-12-20', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major wound complications', 'timeFrame': '4-months post-surgery'}], 'secondaryOutcomes': [{'measure': 'Acute and late toxicities', 'timeFrame': 'acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0'}, {'measure': 'Quality of Life', 'timeFrame': 'pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up', 'description': 'Evaluate quality of life by QOL questionnaires at different time points'}, {'measure': 'Extremity function', 'timeFrame': 'pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up', 'description': 'Evaluate quality of life by MSTS forms at different time points'}, {'measure': 'Pathological remission rate', 'timeFrame': '2 weeks after operation', 'description': 'evaluate the tumor remission rate microscopically'}, {'measure': 'Local control', 'timeFrame': '2-year'}, {'measure': 'Overall Survival', 'timeFrame': '2-year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcoma,Soft Tissue', 'Extremity', 'Trunk', 'Anlotinib', 'Intensity-modulated Radiotherapy', 'Major Wound Complications']}, 'descriptionModule': {'briefSummary': 'To investigate the safety and efficacy of preoperative IMRT and concurrent Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age older than 18-yo\n* Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion.\n* ECOG 0-3\n* Histology reviewed by reference pathologist\n* Lesion can be assessed\n* Can tolerate radiotherapy and Anlotinib\n* Agree contraception.\n* Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed\n\nExclusion Criteria:\n\n* No gross tumor post-resection in other center.\n* Contraindications to Anlotinib, including allergic to Anlotinb, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc.\n* Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc.\n* Benign histology\n* Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)\n* STS can be cured by extensive operation alone.\n* Previous irradiation to the same area\n* Radiological evidence of distant metastases\n* Other contraindications, can't tolerate operation or other treatment needed in this study.\n* Neoadjuvant chemotherapy given or planned."}, 'identificationModule': {'nctId': 'NCT05167994', 'acronym': 'SPARE-01', 'briefTitle': 'Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma （SPARE-01）', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Preoperative Intensity-modulated Radiotherapy (IMRT) With Concurrent Anlotinib Hydrochloride for Localised Extremity or Trunk Sarcoma', 'orgStudyIdInfo': {'id': 'NCC2333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anlotinib arm', 'description': 'Pre-operative IMRT with concurrent and sequential Anlotinib', 'interventionNames': ['Drug: Anlotinib hydrochloride']}], 'interventions': [{'name': 'Anlotinib hydrochloride', 'type': 'DRUG', 'description': 'Anlotinib 12mgQD, from D1 of pre-operative IMRT to 1 month after end of IMRT', 'armGroupLabels': ['Anlotinib arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ningning Lu, Doctor', 'role': 'CONTACT', 'email': 'Ning-Ning.Lu@hotmail.com', 'phone': '+86 01087787630'}, {'name': 'Shu-Lian Wang, M.D.', 'role': 'CONTACT', 'email': 'wsl20040118@yahoo.com', 'phone': '+86 01087788280'}, {'name': 'Shu-Lian Wang, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sheng-Ji Yu, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ning-Ning Lu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ning-Ning Lu', 'role': 'CONTACT', 'email': 'Ning-Ning.Lu@hotmail.com', 'phone': '+868611804268'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Jishuitan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'NINGNING LU', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}