Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2026-02-04 @ 9:54 AM
Study NCT ID:
NCT06384404
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2024-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Upfront Surgical Resection for Osteosarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012516', 'term': 'Osteosarcoma'}], 'ancestors': [{'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2024-04-22', 'studyFirstSubmitQcDate': '2024-04-22', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Health-Related Quality of Life (HRQoL) score from Historical Controls', 'timeFrame': 'approximately 1 year', 'description': 'Modified age-based PROMIS measures will be used to assess HRQoL changes (PROMIS 25 Parent Proxy will be used for ages 5-7; PROMIS 25 for 8-17; PROMIS 29+2 for 18+)\n\nPROMIS 25 (and PROMIS 25 Parent Proxy) contain six, 4-item short forms for domains: physical function mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference; along with a pain intensity item. Scores for each domain range from 1-5 (pain intensity 0-10). Responses to individual items are coded to values and summed to generate a total raw score. Total raw scores are converted/rescaled into a standardized T-score for each participant with a mean of 50 and a standard deviation (SD) of 10. Higher PROMIS T-scores represent more of the concept being measured\n\nPROMIS 29+2 is similar to PROMIS 25 with the exception of a social roles/activities domain in place of peer relationships, and also includes sleep disturbance and cognitive function domains. Scores are determined as described for PROMIS 25'}], 'secondaryOutcomes': [{'measure': 'Event Free Survival', 'timeFrame': 'Up to 2 years', 'description': 'The number of participants with event-free survival (EFS) will be determined. Event-free survival will be defined as the time from diagnosis until disease progression, recurrence at any site, secondary malignancy, death, or last follow-up, whichever is observed first'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteosarcoma']}, 'referencesModule': {'references': [{'pmid': '19255220', 'type': 'BACKGROUND', 'citation': 'Imran H, Enders F, Krailo M, Sim F, Okuno S, Hawkins D, Neglia J, Randall RL, Womer R, Mascarenhas L, Arndt CA. Effect of time to resumption of chemotherapy after definitive surgery on prognosis for non-metastatic osteosarcoma. J Bone Joint Surg Am. 2009 Mar 1;91(3):604-12. doi: 10.2106/JBJS.H.00449.'}, {'pmid': '3520317', 'type': 'BACKGROUND', 'citation': 'Link MP, Goorin AM, Miser AW, Green AA, Pratt CB, Belasco JB, Pritchard J, Malpas JS, Baker AR, Kirkpatrick JA, et al. The effect of adjuvant chemotherapy on relapse-free survival in patients with osteosarcoma of the extremity. N Engl J Med. 1986 Jun 19;314(25):1600-6. doi: 10.1056/NEJM198606193142502.'}, {'pmid': '29912746', 'type': 'BACKGROUND', 'citation': 'Xu J, Xie L, Guo W. Neoadjuvant Chemotherapy Followed by Delayed Surgery: Is it Necessary for All Patients With Nonmetastatic High-Grade Pelvic Osteosarcoma? Clin Orthop Relat Res. 2018 Nov;476(11):2177-2186. doi: 10.1097/CORR.0000000000000387.'}, {'pmid': '32176331', 'type': 'BACKGROUND', 'citation': 'Reed DR, Metts J, Pressley M, Fridley BL, Hayashi M, Isakoff MS, Loeb DM, Makanji R, Roberts RD, Trucco M, Wagner LM, Alexandrow MG, Gatenby RA, Brown JS. An evolutionary framework for treating pediatric sarcomas. Cancer. 2020 Jun 1;126(11):2577-2587. doi: 10.1002/cncr.32777. Epub 2020 Mar 16.'}, {'pmid': '19450974', 'type': 'BACKGROUND', 'citation': 'Hinds PS, Gattuso JS, Billups CA, West NK, Wu J, Rivera C, Quintana J, Villarroel M, Daw NC. Aggressive treatment of non-metastatic osteosarcoma improves health-related quality of life in children and adolescents. Eur J Cancer. 2009 Jul;45(11):2007-14. doi: 10.1016/j.ejca.2009.04.020. Epub 2009 May 18.'}, {'pmid': '3166399', 'type': 'BACKGROUND', 'citation': 'Bell RS, Roth YF, Gebhardt MC, Bell DF, Rosenberg AE, Mankin HJ, Suit HD. Timing of chemotherapy and surgery in a murine osteosarcoma model. Cancer Res. 1988 Oct 1;48(19):5533-8.'}]}, 'descriptionModule': {'briefSummary': "The goal of this pilot study is to learn about patients with newly diagnosed osteosarcoma of an extremity, and whether surgically removing the tumor prior to the administration of any chemotherapy will improve functional outcomes. In order to learn about the patient's experience, the study team will administer questionnaires to the patient and surgeon at various timepoints to assess recovery and the function of the extremity.", 'detailedDescription': 'This prospective, non-randomized pilot study will assess patient-reported functional outcomes of upfront surgical resection in patients with newly diagnosed, biopsy-proven, localized osteosarcoma of the extremity or the pelvis. Following biopsy, all patients will undergo wide excision of the tumor followed by systemic multi-agent cytotoxic chemotherapy consisting of a regimen at least equivalent to the standard of care of high dose Methotrexate, Doxorubicin, and Cisplatin (MAP). Patients and/or their parent/guardian will be administered PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaires, while surgeons will be administered the Musculoskeletal Tumor Society (MSTS) questionnaire at various timepoints through the first year post-surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with newly diagnosed osteosarcoma with plans to undergo an upfront surgical resection of their tumor.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have newly diagnosed, previously untreated, localized, high-grade osteosarcoma of an extremity (verified by histopathology) with plans to undergo upfront surgical resection of the tumor followed by systemic chemotherapy.\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2 (Karnofsky will be used for patients \\>16 years of age and Lansky score for patients \\<= 16 years of age)\n\nExclusion Criteria:\n\n* Patients with metastatic disease at diagnosis\n* Initiation of systemic therapy prior to enrollment\n* Prior history of cancer\n* Prior radiation therapy\n* Active life-threatening infection\n* Pregnancy (negative pregnancy test result must be obtained for female patients of childbearing potential)'}, 'identificationModule': {'nctId': 'NCT06384404', 'acronym': 'UFSR for OS', 'briefTitle': 'Upfront Surgical Resection for Osteosarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Functional Outcomes in Patients Who Undergo Upfront Surgical Resection for High-Grade Osteosarcoma of the Extremity: A Pilot Study', 'orgStudyIdInfo': {'id': '2023-14741'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Osteosarcoma', 'description': 'Patients with newly diagnosed osteosarcoma', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'PROMIS questionnaire', 'armGroupLabels': ['Osteosarcoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Zylber', 'role': 'CONTACT', 'email': 'rzylber@montefiore.org', 'phone': '718-741-2356'}, {'name': 'Alice Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Geller, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'Rebecca Zylber, NP', 'role': 'CONTACT', 'email': 'rzylber@montefiore.org', 'phone': '718-741-2356'}], 'overallOfficials': [{'name': 'Alice Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}