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JOURNAL ONKOLOGIE – STUDIE
RESAR

REtroperitoneal SArcoma Registry: an International Prospective Initiative

Rekrutierend

NCT-Nummer:
NCT03838718

Studienbeginn:
September 2016

Letztes Update:
12.02.2019

Wirkstoff:
-

Indikation (Clinical Trials):
Sarcoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Collaborator:
TransAtlantic Retroperitoneal Sarcoma Working Group

Studienleiter

Alessandro Gronchi, MD
Principal Investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Marco Fiore, MD
Study Director
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Kontakt

Alessandro Gronchi, MD
Kontakt:
Phone: +39022390
Phone (ext.): 3234
E-Mail: alessandro.gronchi@istitutotumori.mi.it» Kontaktdaten anzeigen

Studienlocations
(3 von 22)

University Medical Center and Medical Faculty Mannheim, University of Heidelberg
Mannheim
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Peter Hohenberger, MD
E-Mail: peter.hohenberger@medma.uni-heidelberg.de» Ansprechpartner anzeigen
Fondazione IRCCS Istituto Nazionale dei Tumori
20133 Milan
ItalyRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Retroperitoneal sarcomas (RPS) are rare tumors accounting for 10-15% of all soft tissue

sarcomas (STS). They arise between retroperitoneal organs and among vital structures (ie

major abdominal vessels) in an anatomical compartment that is not readily accessible by

physical examination. Four main histotypes account for about 80% of all cases:

well-differentiated liposarcoma (WDLPS), dedifferentiated liposarcoma (DDLPS), leiomyosarcoma

(LMS) and solitary fibrous tumor (SFT).

Compared to sarcomas at other anatomic sites, RPS are burdened by a higher local recurrence

(LR) rate (50% at 5 years) and a poorer overall survival (OS) rate (50% at 5-years). The

natural history of RPS as a whole group reflects the strong tendency of lipomatous tumors

(WDLPS and DDLPS, which account for about 50% of RPS) to recur locally. Indeed, outcome of

primary RPS is highly related to the histological subtype.

WDLPS are characterized by a relatively lower LR rate, negligible metastatic potential and a

favorable overall survival. These tumors however, still may recur locally even years after

the primary resection. Intermediate grade DDLPS are characterized by a strong tendency to

recur locally and low metastatic potential. High grade DDLPS has a high risk of both local

recurrence and distant metastasis. LMS are usually intermediate or high-grade tumors with a

strong tendency to develop distant metastasis; with an adequate resection, it is relatively

common to obtain a durable local control. Classic SFT usually fare well after surgery, with a

low rate of local recurrence and distant metastasis.

Historically, surgery emerged as the only potentially curative option in the localized

setting. In the last few years there has been lively debate as to how far should a surgeon

resect in order to obtain a margin that could be considerate adequate. This issue is

particularly challenging in this anatomical compartment where widening the surgical margins

means resecting adjacent organs.

Since 2002 an 'extended' surgical approach has been proposed for primary RPS patients. The

concept was that surgical margins could be improved by encompassing the tumor with en-bloc

resection of adjacent organs. The aim was to obtain reduced local recurrence and improved

survival. This approach has proven to be effective. In particular, this surgical approach has

been supported by an experimental model, retrospective comparisons, pathology studies

demonstrating adjacent organ involvement, and reports of high rates of residual tumor at

re-excision after conventional (non-extended) primary surgery. Finally, this approach has

been shown to be safe after both short and long term follow-up.

Radiotherapy is an option for RPS, especially in the preoperative setting, but currently the

best evidence for efficacy comes form retrospective, mainly single-center, small size series.

The results of such studies are controversial and high quality data are lacking. A randomized

prospective study led by EORTC (STRASS) is ongoing but results are not expected for several

years.

The role of chemotherapy in the localized disease is also still under investigation,

especially in high grade tumors. So far, there is no agreement on the optimal treatment

strategy, even within reference centers, regarding the use of both chemo- and radiotherapy.

In the recent years European and North-American centers joined the panel of expert and this

led to the formation of the TransAtlantic Retroperitoneal Sarcoma Working Group (TARPSWG),

which now consists of more than 50 representatives from sarcoma centers from all over the

world.

The aim of this collaboration is to expand the knowledge of the disease and formulate shared,

standardized principles of treatment. A retrospective study has been carried out and recently

published by the group to better define patients' outcome and prognostic factors after

surgical resection of primary tumors. Other retrospective studies have been published

focusing on post-relapse outcome, postsurgical morbidity and local recurrence treatment. This

collaboration has also just recently led to the development of consensus guidelines for the

treatment of primary and recurrent and metastatic RPS.

To take advantage of the group collaboration, TARPSWG promoted a prospective collection of

clinical, radiological and pathologic data for RPS.

This study is aimed to prospectively collect standardized clinical data and radiological and

pathological material from primary RPS patients treated with surgery at reference centers.

Patient outcome will be evaluated in terms of overall survival (OS), disease-free survival

(DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM).

STUDY DESIGN

This is a prospective, multicentric observational study under the supervision of TARPSWG

(TransAtlantic Retroperitoneal Sarcoma Working Group) aimed to prospectively collect clinical

data and prospectively store radiological and pathological material from patients affected by

primary RPS treated with surgery.

Patients with a diagnosis of primary RPS who meet the eligibility criteria will be invited to

participate to the current study.

Eligible patients will receive full information on the type of surgery proposed and on the

data and material (radiological and pathological) that will be collected. Eligible and

informed patients who give their consent to participate will be included in the Prospective

Cohort Study (PCS) and will be followed-up prospectively.

A data collection form including patient and tumor-related factors, treatment variables,

follow-up findings, development of and time to local recurrence and status at follow-up has

been constructed and shared among all the participating centers.

Each participating reference center will individually be able to have access to both cross

sectional imaging (CT or MRI images) and pathological material (a representative formalin

block of the tumor). Whenever possible patient identifiers will be removed and patient

confidentiality will be maintained. Any data shared between institutions will be deidentified

and all measures to conceal patient identifiers will be taken.

Each center will be responsible for data-entry and storage of its own patients' data,

radiological examinations and pathological samples. At the time of the analysis each center

is committed to provide the requested updated data to the group.

Follow-up will be based on clinical evaluation and on cross sectional imaging (CT scan of the

thorax and abdomen and/or contrast enhanced MRI of the abdomen) every 4 months for the first

2 years, every 6 months until the 5th year and yearly thereafter.

The overall duration of the project has not been fixed.

Sample size

The number of patients we plan to include in this prospective multicenter study will be 400

patients per year.

STATISTICAL CONSIDERATIONS Continuous variables will be summarized with appropriate summary

statistics such as the mean, median, standard deviation, minimum and maximum. Categorical

variables will be tabulated with frequencies and percentages. We will evaluate OS, DFS, CCI

of DM and LR and correlate this with clinicopathologic factors such as histology, grade, type

of surgery, etc.

DATA COLLECTION Data entry will be performed by every participating center. Data will be

collected in a standardized database, stored by every participating center, and shared with

the group at the time of future studies. Data shared between institutions will be

deidentified and whenever possible all measures to conceal patient identifiers and maintain

patient confidentiality will be taken.

ETHICS It is the responsibility of the investigator to have prospective approval of the trial

protocol, informed consent forms, and other relevant documents, from the IRB/IEC. All

correspondence with the IRB/IEC should be retained in the Investigator File.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- primary RPS operated on in the participating center;

- age>18 years at the time of the first treatment (pediatric patients can not be

included)

- histological confirmed diagnosis according to the WHO criteria done on biopsy or

surgical specimen by dedicated sarcoma pathologist;

- radiological examinations performed (contrast enhanced abdominal CT scan and/or MRI)

prior to surgical resection;

- signed informed consent form;

- adequate compliance of the patients to the plan of follow-up

Exclusion Criteria:

- age<18 years;

- recurrent tumor;

- benign retroperitoneal tumors;

- serious psychiatric disease that precludes informed consent or limits compliance;

- impossibility to ensure adequate follow-up

Studien-Rationale

Primary outcome:

1. Disease-free Survival (Time Frame - 10 years):
Survival after surgery for primary RPS resection; any disease recurrence, local or distant, will be considered as an event at time of first radiological appearance.



Secondary outcome:

1. Overall Survival (Time Frame - 10 years):
Overall Survival computed from date of surgery

2. Crude cumulative incidence of Local recurrence (Time Frame - 10 years):
CCI of Local recurrence computed from date of surgery, and defined as intrabdominal recurrent disease after complete resection

3. Crude cumulative incidence of Distant metastasis (Time Frame - 10 years):
CCI of distant metastasis computed from date of surgery, and defined as hepatic recurrence and / or extrabdominal recurrent disease

4. Morbidity (Time Frame - 60 days):
Postsurgical morbidity according to Clavien-Dindo classification

Quelle: ClinicalTrials.gov


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