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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02986516
Other study ID # ISG SACRO
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 16, 2017
Est. completion date September 2024

Study information

Verified date September 2023
Source Italian Sarcoma Group
Contact Alessandro Gronchi, MD
Phone +390223903714
Email alessandro.gronchi@istitutotumori.mi.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma


Description:

International, multicenter, comparative, open-label, parallel-group, mixed Observational-Randomized Controlled Trial. All the patients, who are candidate for the study will receive full information on the characteristics, potential effectiveness and side effects of the two alternatives treatments: radiotherapy (RT) and surgical treatment Eligible patients will be asked to be randomized in order to receive treatment A (surgery, with or without RT) or treatment B (definitive RT) Who will refuse randomization will be included in the Prospective Cohort Study (PCS) and will be treated accordingly to their choice (treatment option A or treatment option B). The same radiotherapy and surgical regimen will be administered in the PCS and in the Randomized Clinical Trial (RCT) cohort


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Histologically confirmed diagnosis (brachyury expression) of primary sacral chordoma,of any diameter and arising at any site from S1 to coccyx. - Age=18years - ECOG-performance status (PS) 0-2 - No previous antineoplastic therapy - Macroscopic tumor detectable at MRI/CT scan - Patient amenable for surgery - Patient amenable for RT - Written informed consent given before the enrolment, according to International Conference on Harmonisation/good clinical practice (ICH/GCP). Exclusion Criteria: - Distant metastasis - Inability to maintain treatment position - Prior radiotherapy to the pelvic region - Prior therapy for sacral chordoma (including surgery, cryoablation, hyperthermia, etc) - Local conditions that increase the risk of RT toxicity (tumor ulcerated skin infiltration, non-healing soft tissue infection, fistula in treatment field) - Rectal wall infiltration - General conditions that increase the risk of RT toxicity (active sclerodermia, xeroderma pigmentosum, cutaneous porphyria) - Presence of a second active cancer (with the exception of non-melanoma skin cancer in-situ cervix neoplasia and other in-situ neoplasia) - Severe comorbidities resulting in a prognosis of less than 6 months - Inability to give informed consent - Other malignancy within the last 5 years - Performance status = 2 (ECOG). - Significant cardiovascular disease (for example, dyspnea > 2 NYHA) - Significant systemic diseases grade >3 on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity - Women who are pregnant or breast-feeding - Psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Randomized Cohort
Surgical treatment with different approach, based on the characteristics of the tumor or definitive high dose radiotherapy (carbon ion radiotherapy, proton-therapy, mixed photons-proton therapy) will be assigned by randomization
Radiation:
Prospective cohort
Surgical treatment or definitive high dose radiotherapy will be selected by the patients and will be prospectively evaluated

Locations

Country Name City State
Austria Medical University of Graz Graz
Austria EBG GmbH MedAustron Wiener Neustadt Österreich
Germany Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology, Dresden
Germany University Hospital Carl Gustav Carus Dresden Dresden
Germany University Hospital Essen. West German Proton Therapy Center Essen Essen
Germany Heidelberg Ion-Beam Therapy Center - HIT Heidelberg
Hungary National Center for Spinal Disorders Budapest
Italy Istituto Ortopedico Rizzoli Bologna
Italy Azienda Ospedaliero-Universitaria Careggi Firenze
Italy Fondazione IRCCS Istituto Nazionale dei Tumori Milano MI
Italy I.R.C.C.S. Istituto Ortopedico Galeazzi Milano
Italy Istituto Clinico Humanitas Milano
Italy Centro Nazionale di Adroterapia Oncologica - CNAO Pavia
Italy II Clinica Universitaria Ortopedia e Traumatologia AO Pisa Pisa
Italy Istituto Regina Elena - IFO Rome
Italy Agenzia Provinciale per la Protonterapia - AtreP Trento
Japan Saitama Medical Center Saitama
Netherlands Netherlands Cancer Institute Amsterdam
Netherlands Leiden University Medical Center Leiden
Norway Norwegian Radium Hospital/Oslo Univeristi Hospital Oslo
Poland Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie Warsaw
Spain H. Val D'Hebron Barcelona
Spain Hosptial San Pau Barcelona
Spain H. San Carlos Madrid
Spain Hospital Universitario Virgen del Rocío Sevilla
Spain Hospital Universitario Doctor Peset Valencia
United Kingdom The Royal Orthopaedic Hospital Birmingham
United Kingdom Royal National Orthopaedic Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Italian Sarcoma Group

Countries where clinical trial is conducted

Austria,  Germany,  Hungary,  Italy,  Japan,  Netherlands,  Norway,  Poland,  Spain,  United Kingdom, 

References & Publications (47)

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Clarke MJ, Dasenbrock H, Bydon A, Sciubba DM, McGirt MJ, Hsieh PC, Yassari R, Gokaslan ZL, Wolinsky JP. Posterior-only approach for en bloc sacrectomy: clinical outcomes in 36 consecutive patients. Neurosurgery. 2012 Aug;71(2):357-64; discussion 364. doi: 10.1227/NEU.0b013e31825d01d4. — View Citation

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Imai R, Kamada T, Sugahara S, Tsuji H, Tsujii H. Carbon ion radiotherapy for sacral chordoma. Br J Radiol. 2011 Dec;84 Spec No 1(Spec Iss 1):S48-54. doi: 10.1259/bjr/13783281. Epub 2011 Mar 22. — View Citation

Kayani B, Hanna SA, Sewell MD, Saifuddin A, Molloy S, Briggs TW. A review of the surgical management of sacral chordoma. Eur J Surg Oncol. 2014 Nov;40(11):1412-20. doi: 10.1016/j.ejso.2014.04.008. Epub 2014 Apr 25. — View Citation

Kelley MJ, Korczak JF, Sheridan E, Yang X, Goldstein AM, Parry DM. Familial chordoma, a tumor of notochordal remnants, is linked to chromosome 7q33. Am J Hum Genet. 2001 Aug;69(2):454-60. doi: 10.1086/321982. Epub 2001 Jul 10. — View Citation

Kim JE, Pang J, Christensen JM, Coon D, Zadnik PL, Wolinsky JP, Gokaslan ZL, Bydon A, Sciubba DM, Witham T, Redett RJ, Sacks JM. Soft-tissue reconstruction after total en bloc sacrectomy. J Neurosurg Spine. 2015 Jun;22(6):571-81. doi: 10.3171/2014.10.SPINE14114. Epub 2015 Mar 27. — View Citation

Lee-Jones L, Aligianis I, Davies PA, Puga A, Farndon PA, Stemmer-Rachamimov A, Ramesh V, Sampson JR. Sacrococcygeal chordomas in patients with tuberous sclerosis complex show somatic loss of TSC1 or TSC2. Genes Chromosomes Cancer. 2004 Sep;41(1):80-5. doi: 10.1002/gcc.20052. — View Citation

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Miozzo M, Dalpra L, Riva P, Volonta M, Macciardi F, Pericotti S, Tibiletti MG, Cerati M, Rohde K, Larizza L, Fuhrman Conti AM. A tumor suppressor locus in familial and sporadic chordoma maps to 1p36. Int J Cancer. 2000 Jul 1;87(1):68-72. — View Citation

Oakley GJ, Fuhrer K, Seethala RR. Brachyury, SOX-9, and podoplanin, new markers in the skull base chordoma vs chondrosarcoma differential: a tissue microarray-based comparative analysis. Mod Pathol. 2008 Dec;21(12):1461-9. doi: 10.1038/modpathol.2008.144. Epub 2008 Sep 26. — View Citation

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Puri A, Agarwal MG, Shah M, Srinivas CH, Shukla PJ, Shrikhande SV, Jambhekar NA. Decision making in primary sacral tumors. Spine J. 2009 May;9(5):396-403. doi: 10.1016/j.spinee.2008.10.001. Epub 2008 Dec 6. — View Citation

Royston P, Parmar MK. The use of restricted mean survival time to estimate the treatment effect in randomized clinical trials when the proportional hazards assumption is in doubt. Stat Med. 2011 Aug 30;30(19):2409-21. doi: 10.1002/sim.4274. Epub 2011 May 25. — View Citation

Schwab JH, Boland PJ, Agaram NP, Socci ND, Guo T, O'Toole GC, Wang X, Ostroumov E, Hunter CJ, Block JA, Doty S, Ferrone S, Healey JH, Antonescu CR. Chordoma and chondrosarcoma gene profile: implications for immunotherapy. Cancer Immunol Immunother. 2009 Mar;58(3):339-49. doi: 10.1007/s00262-008-0557-7. Epub 2008 Jul 19. — View Citation

Staab A, Rutz HP, Ares C, Timmermann B, Schneider R, Bolsi A, Albertini F, Lomax A, Goitein G, Hug E. Spot-scanning-based proton therapy for extracranial chordoma. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e489-96. doi: 10.1016/j.ijrobp.2011.02.018. Epub 2011 Apr 15. — View Citation

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Stacchiotti S, Casali PG, Lo Vullo S, Mariani L, Palassini E, Mercuri M, Alberghini M, Pilotti S, Zanella L, Gronchi A, Picci P. Chordoma of the mobile spine and sacrum: a retrospective analysis of a series of patients surgically treated at two referral centers. Ann Surg Oncol. 2010 Jan;17(1):211-9. doi: 10.1245/s10434-009-0740-x. Epub 2009 Oct 22. — View Citation

Stacchiotti S, Sommer J; Chordoma Global Consensus Group. Building a global consensus approach to chordoma: a position paper from the medical and patient community. Lancet Oncol. 2015 Feb;16(2):e71-83. doi: 10.1016/S1470-2045(14)71190-8. — View Citation

Steinstrater O, Grun R, Scholz U, Friedrich T, Durante M, Scholz M. Mapping of RBE-weighted doses between HIMAC- and LEM-Based treatment planning systems for carbon ion therapy. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):854-60. doi: 10.1016/j.ijrobp.2012.01.038. Epub 2012 Apr 6. — View Citation

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Tirabosco R, Mangham DC, Rosenberg AE, Vujovic S, Bousdras K, Pizzolitto S, De Maglio G, den Bakker MA, Di Francesco L, Kalil RK, Athanasou NA, O'Donnell P, McCarthy EF, Flanagan AM. Brachyury expression in extra-axial skeletal and soft tissue chordomas: a marker that distinguishes chordoma from mixed tumor/myoepithelioma/parachordoma in soft tissue. Am J Surg Pathol. 2008 Apr;32(4):572-80. doi: 10.1097/PAS.0b013e31815b693a. — View Citation

Uhl M, Edler L, Jensen AD, Habl G, Oelmann J, Roder F, Jackel O, Debus J, Herfarth K. Randomized phase II trial of hypofractionated proton versus carbon ion radiation therapy in patients with sacrococcygeal chordoma-the ISAC trial protocol. Radiat Oncol. 2014 Apr 29;9:100. doi: 10.1186/1748-717X-9-100. — View Citation

Varga PP, Szoverfi Z, Fisher CG, Boriani S, Gokaslan ZL, Dekutoski MB, Chou D, Quraishi NA, Reynolds JJ, Luzzati A, Williams R, Fehlings MG, Germscheid NM, Lazary A, Rhines LD. Surgical treatment of sacral chordoma: prognostic variables for local recurrence and overall survival. Eur Spine J. 2015 May;24(5):1092-101. doi: 10.1007/s00586-014-3728-6. Epub 2014 Dec 23. — View Citation

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Yamada Y, Laufer I, Cox BW, Lovelock DM, Maki RG, Zatcky JM, Boland PJ, Bilsky MH. Preliminary results of high-dose single-fraction radiotherapy for the management of chordomas of the spine and sacrum. Neurosurgery. 2013 Oct;73(4):673-80; discussion 680. doi: 10.1227/NEU.0000000000000083. — View Citation

Yanagi T, Kamada T, Tsuji H, Imai R, Serizawa I, Tsujii H. Dose-volume histogram and dose-surface histogram analysis for skin reactions to carbon ion radiotherapy for bone and soft tissue sarcoma. Radiother Oncol. 2010 Apr;95(1):60-5. doi: 10.1016/j.radonc.2009.08.041. Epub 2009 Sep 18. — View Citation

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* Note: There are 47 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Relapse Free Survival (RFS) The time from randomization or treatment start date to the date of local disease relapse, distant disease relapse, second primary malignancy or death from any cause, whichever occurred first. 5 years
Secondary Overall Survival (OS) The time from randomization or treatment start date to the date of death from any cause The patients will be followed in term of Overall Survival, for all the study period (expected average: 10 years)
Secondary Survival Post Progression (SPP) The time from local disease relapse, distant disease relapse or second primary malignancy, whichever occurred first, to the date of death from any cause Expected average: 36 months
Secondary Local Relapse Failure (LRF) The time from randomization or treatment start date to the date of local disease relapse Expected average: 60 months
Secondary Distant Relapse Failure (DRF) The time from randomization or treatment start date to the date of distant disease relapse Expected average: 60 months
Secondary Best Response rate to definitive radiotherapy Best Response rate to definitive radiotherapy At 12 months, 2 years and 5 years after radiotherapy
Secondary Time to best response rate to definitive radiotherapy Time to best response rate to definitive radiotherapy At 12 months, 2 years and 5 years after radiotherapy
Secondary Adverse Events Incidence Adverse Events incidence At end of treatment , 6 months , 12 months 2 years and 5 years after surgery or radiotherapy
Secondary Evaluation of quality of life measured with Functional Assessment of Cancer Therapy General Evaluation of quality of life measured with Functional Assessment of Cancer Therapy General every 6 months (expected average: 5 years)
Secondary Evaluation of quality of life measured with Brief Inventory Pain questionnaires Evaluation of quality of life measured with Brief Inventory Pain questionnaires every 6 months (expected average: 5 years)
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