Clinical trial · Interventional
Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease
Title of Study: SAcral Chordoma: a Randomized & Observational Study on Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)
NCT02986516CI-TRIAL-00099984SACROrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chordoma | Chordoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prospective cohort | Radiation | — | UNRESOLVED |
| Randomized Cohort | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Randomized Cohort
- description
- Participants who will decided to undergo to randomization, will receive surgical treatment or definitive radiotherapy according with randomization assignment
- interventionNames
- Other: Randomized Cohort
- type
- ACTIVE_COMPARATOR
- label
- Prospective Cohort
- description
- Participants who will not decide to be randomized, will received the surgical or definite radiotherapy treatment according to their choice
- interventionNames
- Radiation: Prospective cohort
Primary outcomes (1)
- measure
- Relapse Free Survival (RFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (48)
- BACKGROUNDStiller CA, Trama A, Brewster DH, Verne J, Bouchardy C, Navarro C, Chirlaque MD, Marcos-Gragera R, Visser O, Serraino D, Weiderpass E, Dei Tos AP, Ascoli V; RARECARE Working Group. Descriptive epidemiology of Kaposi sarcoma in Europe. Report from the RARECARE project. Cancer Epidemiol. 2014 Dec;38(6):670-8. doi: 10.1016/j.canep.2014.09.009. Epub 2014 Oct 22. PMID 25454979
- BACKGROUNDTirabosco 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. PMID 18301055
- BACKGROUNDBrien EW, Mirra JM, Ippolito V. Chondroblastoma arising from a nonepiphyseal site. Skeletal Radiol. 1995 Apr;24(3):220-2. doi: 10.1007/BF00228930. PMID 7610417
- BACKGROUNDVujovic S, Henderson S, Presneau N, Odell E, Jacques TS, Tirabosco R, Boshoff C, Flanagan AM. Brachyury, a crucial regulator of notochordal development, is a novel biomarker for chordomas. J Pathol. 2006 Jun;209(2):157-65. doi: 10.1002/path.1969. PMID 16538613
- BACKGROUNDMiozzo 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. PMID 10861454
- BACKGROUNDKelley 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. PMID 11452362
- BACKGROUNDLee-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.