Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 26 September 2023
• Main ID: NCT02986516
• Date of registration: 02/12/2016
• Prospective Registration: Yes
• Primary sponsor: Italian Sarcoma Group
• Public title: Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease SACRO
• Scientific title: Title of Study: SAcral Chordoma: a Randomized & Observational Study on Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)
• Date of first enrolment: March 16, 2017
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02986516
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

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

Contacts

• Name: Piero Fossati, MD
• Affiliation: MedAustron Graz-Austria

• Name: Alessandro Gronchi, MD
• Affiliation: Istituto Nazionale Tumori Milan-Italy

• Name: Alessandro Gronchi, MD

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chordoma

Intervention(s)

Radiation: Prospective cohort

Other: Randomized Cohort

Primary Outcome(s)

Relapse Free Survival (RFS) [Time Frame: 5 years]

Secondary Outcome(s)

Best Response rate to definitive radiotherapy [Time Frame: At 12 months, 2 years and 5 years after radiotherapy]

Distant Relapse Failure (DRF) [Time Frame: Expected average: 60 months]

Evaluation of quality of life measured with Functional Assessment of Cancer Therapy General [Time Frame: every 6 months (expected average: 5 years)]

Adverse Events Incidence [Time Frame: At end of treatment , 6 months , 12 months 2 years and 5 years after surgery or radiotherapy]

Time to best response rate to definitive radiotherapy [Time Frame: At 12 months, 2 years and 5 years after radiotherapy]

Local Relapse Failure (LRF) [Time Frame: Expected average: 60 months]

Evaluation of quality of life measured with Brief Inventory Pain questionnaires [Time Frame: every 6 months (expected average: 5 years)]

Survival Post Progression (SPP) [Time Frame: Expected average: 36 months]

Overall Survival (OS) [Time Frame: The patients will be followed in term of Overall Survival, for all the study period (expected average: 10 years)]

Secondary ID(s)

ISG SACRO

Source(s) of Monetary Support

Please refer to primary and secondary sponsors