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NCT02986516 | RECRUITING | Chordoma

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

Italian Sarcoma Group

Brief Summary:

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

Condition or disease

Chordoma

Intervention/treatment

Randomized Cohort

Prospective cohort

Phase

NA

Detailed 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

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Title of Study: SAcral Chordoma: a Randomized & Observational Study on Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)
Actual Study Start Date : 2017-03-16
Estimated Primary Completion Date : 2025-09
Estimated Study Completion Date : 2025-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease

Location Details

NCT02986516

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Austria,

Medical University of Graz

Graz, Austria,

RECRUITING

Austria, Austria

EBG GmbH MedAustron

Wiener Neustadt, Austria, Austria, 2700

NOT YET RECRUITING

Germany,

Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology,

Dresden, Germany,

NOT YET RECRUITING

Germany,

University Hospital Carl Gustav Carus Dresden

Dresden, Germany,

RECRUITING

Germany,

University Hospital Essen. West German Proton Therapy Center Essen

Essen, Germany,

NOT YET RECRUITING

Germany,

Heidelberg Ion-Beam Therapy Center - HIT

Heidelberg, Germany,

NOT YET RECRUITING

Hungary,

National Center for Spinal Disorders

Budapest, Hungary,

RECRUITING

Italy, MI

IRCCS National Cancer Institute Foundation

Milan, MI, Italy, 20133

RECRUITING

Italy,

Rizzoli Orthopedic Institute

Bologna, Italy, 40136

NOT YET RECRUITING

Italy,

Careggi University Hospital

Florence, Italy, 50134

RECRUITING

Italy,

Humanitas Clinical Institute

Milan, Italy, 20089

ACTIVE NOT RECRUITING

Italy,

I.R.C.C.S. Galeazzi Orthopedic Institute

Milan, Italy, 20161

RECRUITING

Italy,

National Center for Oncological Hadrontherapy - CNAO

Pavia, Italy, 27100

RECRUITING

Italy,

II University Clinic Orthopedics and Traumatology AO Pisa

Pisa, Italy, 56124

RECRUITING

Italy,

Regina Elena Institute - IFO

Rome, Italy, 00100

ACTIVE NOT RECRUITING

Italy,

Provincial Agency for Proton Therapy - AtreP

Trento, Italy, 38122

RECRUITING

Japan,

Saitama Medical Center

Saitama, Japan,

NOT YET RECRUITING

Netherlands,

Netherlands Cancer Institute

Amsterdam, Netherlands,

NOT YET RECRUITING

Netherlands,

Leiden University Medical Center

Leiden, Netherlands,

RECRUITING

Norway,

Norwegian Radium Hospital/Oslo University Hospital

Oslo, Norway, N-0424

ACTIVE NOT RECRUITING

Poland,

Oncology Center-Institute Maria Skłodowska-Curie

Warsaw, Poland,

RECRUITING

Spain,

H. Val D'Hebron

Barcelona, Spain,

ACTIVE NOT RECRUITING

Spain,

Hosptial San Pau

Barcelona, Spain,

NOT YET RECRUITING

Spain,

H. San Carlos

Madrid, Spain,

RECRUITING

Spain,

Virgen del Rocío University Hospital

Seville, Spain,

NOT YET RECRUITING

Spain,

Doctor Peset University Hospital

Valencia, Spain, 46017

NOT YET RECRUITING

United Kingdom,

The Royal Orthopaedic Hospital

Birmingham, United Kingdom,

NOT YET RECRUITING

United Kingdom,

Royal National Orthopaedic Hospital

London, United Kingdom,