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JOURNAL ONKOLOGIE – STUDIE
SACRO

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

Rekrutierend

NCT-Nummer:
NCT02986516

Studienbeginn:
März 2017

Letztes Update:
13.09.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Chordoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Italian Sarcoma Group

Collaborator:
-

Studienleiter

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

Kontakt

Studienlocations
(3 von 28)

Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology,
Dresden
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Mechthild Krause, Prof/MD» Ansprechpartner anzeigen
I.R.C.C.S. Istituto Ortopedico Galeazzi
20161 Milano
ItalyAktiv, nicht rekrutierend» Google-Maps
Istituto Regina Elena - IFO
00100 Rome
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Maria Grazia Petrongari, MD
Phone: +39065266
Phone (ext.): 6894
E-Mail: mariagrazia.petrongari@ifo.gov.it» Ansprechpartner anzeigen
Agenzia Provinciale per la Protonterapia - AtreP
38122 Trento
ItalyAktiv, nicht rekrutierend» Google-Maps
Norwegian Radium Hospital/Oslo Univeristi Hospital
N-0424 Oslo
NorwayRekrutierend» Google-Maps
Ansprechpartner:
Øyvind S. Bruland, MD
Phone: +47 22 93 47
Phone (ext.): 67
E-Mail: osb@ous-hf.no

Øyvind S. Bruland, MD» Ansprechpartner anzeigen
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
Warsaw
PolandAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Relapse Free Survival (RFS) (Time Frame - 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:

1. Overall Survival (OS) (Time Frame - 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) (Time Frame - 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) (Time Frame - Expected average: 60 months):
The time from randomization or treatment start date to the date of local disease relapse

4. Distant Relapse Failure (DRF) (Time Frame - 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 (Time Frame - 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 (Time Frame - At 12 months, 2 years and 5 years after radiotherapy):
Time to best response rate to definitive radiotherapy

7. Adverse Events Incidence (Time Frame - 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 (Time Frame - 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 (Time Frame - every 6 months (expected average: 5 years)):
Evaluation of quality of life measured with Brief Inventory Pain questionnaires

Studien-Arme

  • Experimental: Randomized Cohort
    Participants who will decided to undergo to randomization, will receive surgical treatment or definitive radiotherapy according with randomization assignment
  • Active Comparator: Prospective Cohort
    Participants who will not decide to be randomized, will received the surgical or definite radiotherapy treatment according to their choice

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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