Upfront Surgical Resection for Osteosarcoma

Официальное название

Functional Outcomes in Patients Who Undergo Upfront Surgical Resection for High-Grade Osteosarcoma of the Extremity: A Pilot Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Questionnaire
  PROMIS questionnaire

Первичные конечные точки

• Change in Health-Related Quality of Life (HRQoL) score from Historical Controls [Срок оценки: approximately 1 year]

Вторичные конечные точки (1)

• Event Free Survival [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• 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.
• 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)

Критерии исключения

• Patients with metastatic disease at diagnosis
• Initiation of systemic therapy prior to enrollment
• Prior history of cancer
• Prior radiation therapy
• Active life-threatening infection
• Pregnancy (negative pregnancy test result must be obtained for female patients of childbearing potential)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Montefiore Medical Center — The Bronx

Публикации

• 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 19255220
• 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 3520317
• 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 29912746
• 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 32176331
• 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 19450974
• 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. PMID 3166399
• Lee, Soo-Yong, et al. "The effect of surgical timing on the outcome of localized extremity osteosarcoma [abstract]." In: ISOLS/MSTS 2014 Annual Meeting.

Идентификаторы

NCT: NCT06384404 · 2023-14741

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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