Osteosarcoma in Patients Older Than 40 Years. Prognostic Factors and Survival

Osteosarcoma Clinical Trial

Official title:

Our Experience About Limb and Pelvic Osteosarcoma in Patients Older Than 40 Years and Comparative Study With the Age Group < 40 Years. Prognostic Factors, Survival, Amputation Rate and Limb Salvage Surgery After Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911245
• Other study ID #: IIBSP-OST-2017-67
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this work is to carry out an exhaustive analysis of the characteristics of osteosarcoma in patients with an age equal to or greater than 40 years, in the Hospital de la Santa Creu and Sant Pau in Barcelona, during the years 1986-2016, with the objective to establish the factors that determine the disease and survival, as well as to evaluate the rates of limb salvage and amputation after neodyuvant chemotherapy. With the result of the results, the report of osteosarcoma and the age less than 40 years, with the aim of providing new information that is related to the appearance of osteosarcoma is available from 40 years.

Description:

The main objectives of this study are the following:

• Describe the prognostic factors of osteosarcoma in patients aged 40 years or older, treated at the Hospital de la Santa Creu and Sant Pau in Barcelona during the years 1986-2016, as well as overall survival and disease-free survival.

• Quantify the frequency of limb salvage surgery and amputation, determining the influence of the use of neoadjuvant chemotherapy in the definitive therapeutic management.

• Compare the results obtained with a group formed patients with a range of less than 40 years, diagnosed and treated with osteosarcoma at the Hospital de la Santa Creu i Sant Pau in Barcelona during the same period of years.

The secondary objectives of this study are the following:

• Analyze the frequency of occurrence of local recurrence.

• Determine postoperative complications.

• Evaluate the frequency of distant spread of the disease.

• Describe the characteristics of the group of patients in the study.

• Demonstrate that the incidence of osteosarcoma in adulthood is increasing over the years.

• Determine predisposing factors or lesions to the appearance of osteosarcoma not described in the literature.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

First age group (equal or> 40 years old):

• Inclusion criteria:

• Osteosarcoma localized in axial skeleton or limbs, diagnosis confirmed by performing a biopsy of the lesion in the Hospital of Santa Creu i Sant Pau, and subsequent histological analysis by the Pathological Anatomy Service of the same center, or, by histological review of the sample from the biopsy performed in the reference center of patients from other hospitals.

• Age equal to or greater than 40 years.

• Minimum follow-up of 12 months. The patients included in the study have met all the inclusion criteria.

• Exclusion criteria:

• Osteosarcomas from other locations (head, neck, thorax and cervical, dorsal or lumbosacral spine).

• Age less than 40 years.

• Follow-up less than 12 months.

• Patients who present as a single surgical intervention, and therefore, osteosarcoma was not treated surgically in a definitive manner.

• Patients in whom there is an inconsistency between the histological diagnosis of the biopsy and the resection piece, that is, the diagnosis after the definitive study of the resection piece has not corresponded to the osteosarcoma, although it is outside the histological study of the bone biopsy.

• Patients who have undergone a surgical treatment of their tumor lesion, except in the diagnostic biopsy, in another hospital center.

Second age group (<40 years):

• Inclusion criteria:

• Osteosarcoma localized in axial skeleton or limbs, diagnosis confirmed by performing a biopsy of the lesion in the Hospital of Santa Creu i Sant Pau, and subsequent histological analysis by the Pathological Anatomy Service of the same center, or, by histological review of the sample obtained from the biopsy performed in the reference center of patients from other hospitals.

• Age less than 40 years for the first age group.

• Minimum follow-up of 12 months.

The patients included in the study have met all the inclusion criteria.

• Exclusion criteria:

• Osteosarcomas from other locations (head, neck, thorax and cervical, dorsal or lumbosacral spine).

• Age equal to or greater than 40 years.

• Follow-up less than 12 months.

• Patients subjected to a biopsy as the only surgical intervention, and that therefore, osteosarcoma was not definitively treated surgically.

• Patients in whom there is an incongruence between the histological diagnosis of the biopsy and the resection piece, that is, the diagnosis after the definitive study of the resection piece has not corresponded to that of osteosarcoma, although initially it was after the study Histological examination of the bone biopsy.

• Patients who have undergone a surgical treatment of their tumor lesion, except for the diagnostic biopsy, in another hospital center.

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Other:
• Retrospective study. Analyze of data in medical records
Retrospective study. Analyze of data in medical records

Locations

Country	Name	City	State
Spain	Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Bacci G, Longhi A, Versari M, Mercuri M, Briccoli A, Picci P. Prognostic factors for osteosarcoma of the extremity treated with neoadjuvant chemotherapy: 15-year experience in 789 patients treated at a single institution. Cancer. 2006 Mar 1;106(5):1154-61 — View Citation

Carsi B, Rock MG. Primary osteosarcoma in adults older than 40 years. Clin Orthop Relat Res. 2002 Apr;(397):53-61. — View Citation

Grimer RJ, Cannon SR, Taminiau AM, Bielack S, Kempf-Bielack B, Windhager R, Dominkus M, Saeter G, Bauer H, Meller I, Szendroi M, Folleras G, San-Julian M, van der Eijken J. Osteosarcoma over the age of forty. Eur J Cancer. 2003 Jan;39(2):157-63. — View Citation

Iwata S, Ishii T, Kawai A, Hiruma T, Yonemoto T, Kamoda H, Asano N, Takeyama M. Prognostic factors in elderly osteosarcoma patients: a multi-institutional retrospective study of 86 cases. Ann Surg Oncol. 2014 Jan;21(1):263-8. doi: 10.1245/s10434-013-3210- — View Citation

Joo MW, Shin SH, Kang YK, Kawai A, Kim HS, Asavamongkolkul A, Jeon DG, Kim JD, Niu X, Tsuchiya H, Puri A, Wang EH, Chung SH, Chung YG. Osteosarcoma in Asian Populations Over the Age of 40 Years: A Multicenter Study. Ann Surg Oncol. 2015 Oct;22(11):3557-64 — View Citation

Longhi A, Errani C, Gonzales-Arabio D, Ferrari C, Mercuri M. Osteosarcoma in patients older than 65 years. J Clin Oncol. 2008 Nov 20;26(33):5368-73. doi: 10.1200/JCO.2007.14.9104. Epub 2008 Sep 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic factors of osteosarcoma	The impact of prognostic factors was assessed using the log-rank test in univariate analysis. Multivariate analysis was undertaken using the Cox proportional hazards method, with variables chosen using logistic regression with a backward stepwise approach. Relative risks were calculated using the Cox proportional hazards model with only the noted covariate in the model. A p value <0.05 was considered significant. Confidence intervals of 95 % were calculated for statistical parameters. Statistical analysis was performed using SPSS 24.0 for Windows.	1 year
Primary	Survival of osteosarcoma	Overall survival (OS) was defined as the period from date of diagnosis to date of death or last follow-up, and was calculated using Kaplan-Meier survival curves.	1 year