Upfront Surgical Resection for Osteosarcoma

NCT06384404 | Recruiting

• 1 other identifier: 2023-14741
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteosarcoma

Outcome Measures

Primary Outcomes (1)

• Change in Health-Related Quality of Life (HRQoL) score from Historical Controls

  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+) PROMIS 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 PROMIS 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

  approximately 1 year

Secondary Outcomes (1)

• Event Free Survival

  Up to 2 years

Study Arms (1)

Osteosarcoma

Patients with newly diagnosed osteosarcoma

Other: Questionnaire

Interventions

Questionnaire OTHER

PROMIS questionnaire

Osteosarcoma

Eligibility Criteria

• Age: 5 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed osteosarcoma with plans to undergo an upfront surgical resection of their tumor.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Osteosarcoma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alice Lee, M.D.

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Zylber, NP

CONTACT

718-741-2356; rzylber@montefiore.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: March 25, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)