BACKGROUND: A frontline protocol for newly diagnosed osteosarcoma was conducted simultaneously at St. Jude Children's Research Hospital (sponsor) and Calvo Mackenna Hospital (CMH, partner), a public pediatric hospital and national center for the treatment of bone tumors in Santiago, Chile. PROCEDURE: Of 72 eligible patients, 22 (31%) were enrolled and managed in Santiago, without travel to Memphis. Pathology specimens and imaging material were centrally reviewed at St. Jude. Patients received 12 intensive courses of systemic chemotherapy with hematopoietic growth factor support over 35 weeks, and amputation or limb-salvage surgery as indicated for local control. The sponsor assisted the partner site to establish a clinical research infrastructure and obtain hematopoietic growth factor. Communication among medical and nursing teams was maintained throughout the study. Patient-care and protocol issues were discussed frequently between the two centers via scheduled videoconferences and electronic communications. Auditors monitored appropriate study conduct at the international site. RESULTS: No major discrepancies were identified in histologic findings, staging, or imaging studies. Preliminary results demonstrated similar outcome and treatment tolerance; the 2-year event-free survival estimate was 78.5% (95% CI, 51-100%) for patients treated at CMH (median follow-up, 1.6 years) and 74.3% (95% CI, 62-87%) for patients treated at St. Jude (median follow-up, 4 years). Overall per-patient costs were significantly lower in Chile. CONCLUSIONS: Through a twinning mechanism, it is feasible to simultaneously conduct complex front-line osteosarcoma clinical trials at two institutions in countries with different levels of resources. (c) 2007 Wiley-Liss, Inc.
BACKGROUND: A frontline protocol for newly diagnosed osteosarcoma was conducted simultaneously at St. Jude Children's Research Hospital (sponsor) and Calvo Mackenna Hospital (CMH, partner), a public pediatric hospital and national center for the treatment of bone tumors in Santiago, Chile. PROCEDURE: Of 72 eligible patients, 22 (31%) were enrolled and managed in Santiago, without travel to Memphis. Pathology specimens and imaging material were centrally reviewed at St. Jude. Patients received 12 intensive courses of systemic chemotherapy with hematopoietic growth factor support over 35 weeks, and amputation or limb-salvage surgery as indicated for local control. The sponsor assisted the partner site to establish a clinical research infrastructure and obtain hematopoietic growth factor. Communication among medical and nursing teams was maintained throughout the study. Patient-care and protocol issues were discussed frequently between the two centers via scheduled videoconferences and electronic communications. Auditors monitored appropriate study conduct at the international site. RESULTS: No major discrepancies were identified in histologic findings, staging, or imaging studies. Preliminary results demonstrated similar outcome and treatment tolerance; the 2-year event-free survival estimate was 78.5% (95% CI, 51-100%) for patients treated at CMH (median follow-up, 1.6 years) and 74.3% (95% CI, 62-87%) for patients treated at St. Jude (median follow-up, 4 years). Overall per-patient costs were significantly lower in Chile. CONCLUSIONS: Through a twinning mechanism, it is feasible to simultaneously conduct complex front-line osteosarcoma clinical trials at two institutions in countries with different levels of resources. (c) 2007 Wiley-Liss, Inc.
Authors: Paola Friedrich; Roberta Ortiz; Kelly Strait; Soad Fuentes; Yéssica Gamboa; Ingrid Arambú; María Ah-Chu-Sanchez; Wendy London; Carlos Rodríguez-Galindo; Federico Antillón-Klussmann; Fulgencio Báez Journal: Cancer Date: 2012-09-12 Impact factor: 6.860
Authors: Mohammad H Abu-Arja; Nicolás Rojas Del Río; Andres Morales La Madrid; Alvaro Lassaletta; Scott L Coven; Rosa Moreno; Miguel Valero; Veronica Perez; Felipe Espinoza; Eduardo Fernandez; José Santander; Juan Tordecilla; Veronica Oyarce; Katherine Kopp; Ute Bartels; Ibrahim Qaddoumi; Jonathan L Finlay; Adrián Cáceres; Mauricio Reyes; Ximena Espinoza; Diana S Osorio Journal: JCO Glob Oncol Date: 2021-03
Authors: Namita Sharma; Ayesha Ahmad; Gull M Bhat; Sheikh A Aziz; Mohammad Maqbool Lone; Nisar A Bhat Journal: Indian J Med Paediatr Oncol Date: 2017 Oct-Dec
Authors: Michael W Bishop; Shailesh M Advani; Milena Villarroel; Catherine A Billups; Fariba Navid; Cecilia Rivera; Juan A Quintana; Jami S Gattuso; Pamela S Hinds; Najat C Daw Journal: J Glob Oncol Date: 2017-03-24
Authors: Czar Louie Gaston; Kathleen Taleon; Ken Barsales; Cesar Dimayuga; Jochrys Estanislao; Pamela Fajardo; Albert Quintos; Donnel Rubio; Edward Wang; Ana Patricia Alcasabas Journal: Asian Pac J Cancer Prev Date: 2021-09-01