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

Sponsor
Italian Sarcoma Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT02986516
Collaborator
(none)
100
Enrollment
28
Locations
2
Arms
89.6
Anticipated Duration (Months)
3.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Randomized Cohort
  • Radiation: Prospective cohort
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
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 :
Mar 16, 2017
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Randomized Cohort

Participants who will decided to undergo to randomization, will receive surgical treatment or definitive radiotherapy according with randomization assignment

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
Active Comparator: Prospective Cohort

Participants who will not decide to be randomized, will received the surgical or definite radiotherapy treatment according to their choice

Radiation: Prospective cohort
Surgical treatment or definitive high dose radiotherapy will be selected by the patients and will be prospectively evaluated

Outcome Measures

Primary Outcome Measures

  1. Relapse Free Survival (RFS) [5 years]

    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.

Secondary Outcome Measures

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

    The time from randomization or treatment start date to the date of death from any cause

  2. Survival Post Progression (SPP) [Expected average: 36 months]

    The time from local disease relapse, distant disease relapse or second primary malignancy, whichever occurred first, to the date of death from any cause

  3. Local Relapse Failure (LRF) [Expected average: 60 months]

    The time from randomization or treatment start date to the date of local disease relapse

  4. Distant Relapse Failure (DRF) [Expected average: 60 months]

    The time from randomization or treatment start date to the date of distant disease relapse

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

    Best Response rate to definitive radiotherapy

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

    Time to best response rate to definitive radiotherapy

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

    Adverse Events incidence

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

    Evaluation of quality of life measured with Functional Assessment of Cancer Therapy General

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

    Evaluation of quality of life measured with Brief Inventory Pain questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Graz Graz Austria
2 EBG GmbH MedAustron Wiener Neustadt Österreich Austria 2700
3 Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology, Dresden Germany
4 University Hospital Carl Gustav Carus Dresden Dresden Germany
5 University Hospital Essen. West German Proton Therapy Center Essen Essen Germany
6 Heidelberg Ion-Beam Therapy Center - HIT Heidelberg Germany
7 National Center for Spinal Disorders Budapest Hungary
8 Fondazione IRCCS Istituto Nazionale dei Tumori Milano MI Italy 20133
9 Istituto Ortopedico Rizzoli Bologna Italy 40136
10 Azienda Ospedaliero-Universitaria Careggi Firenze Italy 50134
11 Istituto Clinico Humanitas Milano Italy 20089
12 I.R.C.C.S. Istituto Ortopedico Galeazzi Milano Italy 20161
13 Centro Nazionale di Adroterapia Oncologica - CNAO Pavia Italy 27100
14 II Clinica Universitaria Ortopedia e Traumatologia AO Pisa Pisa Italy 56124
15 Istituto Regina Elena - IFO Rome Italy 00100
16 Agenzia Provinciale per la Protonterapia - AtreP Trento Italy 38122
17 Saitama Medical Center Saitama Japan
18 Netherlands Cancer Institute Amsterdam Netherlands
19 Leiden University Medical Center Leiden Netherlands
20 Norwegian Radium Hospital/Oslo Univeristi Hospital Oslo Norway N-0424
21 Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie Warsaw Poland
22 H. Val D'Hebron Barcelona Spain
23 Hosptial San Pau Barcelona Spain
24 H. San Carlos Madrid Spain
25 Hospital Universitario Virgen del Rocío Sevilla Spain
26 Hospital Universitario Doctor Peset Valencia Spain 46017
27 The Royal Orthopaedic Hospital Birmingham United Kingdom
28 Royal National Orthopaedic Hospital London United Kingdom

Sponsors and Collaborators

  • Italian Sarcoma Group

Investigators

  • Principal Investigator: Alessandro Gronchi, MD, Istituto Nazionale Tumori Milan-Italy
  • Principal Investigator: Piero Fossati, MD, MedAustron Graz-Austria

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Italian Sarcoma Group
ClinicalTrials.gov Identifier:
NCT02986516
Other Study ID Numbers:
  • ISG SACRO
First Posted:
Dec 8, 2016
Last Update Posted:
Nov 1, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Chordoma

Study Results

No Results Posted as of Nov 1, 2021