Study in Low Risk Gastrointestinal Stromal Tumor (GISTs)

Completed

Interventions: Other: Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments)

Brief Summary: This is a multi-institutional retrospective study in order to identify the most relevant and advisable features of follow-up, and to explore its impact on principal clinical outcomes. Moreover, a dedicated effort will be pursued to identify the peculiar characteristics (if any) of patients that experienced recurrence of the disease.

The study will collect data about patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020

Detailed Description: In the field of soft tissue sarcomas, Gastrointestinal Stromal Tumors (GIST) represents a really peculiar neoplasm for its biological and clinical properties. Surgery (if feasible) is the main therapeutic approach for all the patients with localized disease, while a pharmacological adjuvant treatment is reserved to those with a relevant risk of recurrence/progression.

After tumor removal, clinical and radiological follow-up is of central importance to early intercept recurrence and to evaluate the most correct subsequent therapeutic approach. In particular, for the group of patients with GIST at very-low and low risk of recurrence/progression, the evidences to support a specific follow-up program and its features are poor.

On the basis of the aforementioned considerations, we propose a multi-institutional retrospective study in order to identify the most relevant and advisable features of follow-up, and to explore its impact on principal clinical outcomes. Moreover, a dedicated effort will be pursued to identify the peculiar characteristics (if any) of patients that experienced recurrence of the disease.

The study will collect data about patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020

Recruitment & Eligibility

Inclusion Criteria

>18 years at diagnosis
primary GIST removed by surgery or endoscopic procedures
availability of medical data needed for the study
very-low and low risk GIST defined as:
- largest size of < 3 cm (for all sites of origin)
- gastric GIST with ≤ 5/50 High Power Fields (HPF) mitoses and ≤ 10 cm in the largest size
- gastric GIST with > 5/50 HPF mitoses and ≤ 5 cm in the largest size
- intestinal GIST with ≤ 5/50 HPF mitoses and ≤ 5 cm in the largest size

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Low Risk GISTs	Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments)	This cohort include patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020.

Primary Outcome Measures

Name	Time	Method
To evaluate the onset of other neoplasms in very-low and low risk GIST patients	Chage from baseline (time of diagnosis) at 5 years	Onset of other neoplasm will be recoreded
To describe the most relevant features of follow-up in very-low and low risk GIST patients	At 5 years	Collection of retrospectively imaging characteristics.

Secondary Outcome Measures

Name	Time	Method
To assess baseline clinical and disease-specific factors with possible impact on survival analyses.	Every 3 months (Month 3, Month 6, Month 9...) up to 5 years	Collection of clinical symptoms, pathological and molecular characteristics at disease presentation/diagnosis
Recurrence-free survival (RFS)	Every 3 months (Month 3, Month 6, Month 9...) up to 5 years	Time elapsed form the treatment (any) start and the onset of recurrence
Overall survival (OS).	at 5 years	Time elapsed for the diagnosis to the death for any cause
Post-recurrence progression-free survival (PR-PFS)	Every 3 months (Month 3, Month 6, Month 9...) up to 5 years	Time elapsed form the onset of 1st progression to a further progression
Disease-Specific survival (DSS)	at 5 years	Time elapsed for the diagnosis to the death of disease

Locations (13): Fondazione IRCCS INT Milano
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Milano, Italy
Azienda Ospedaliero-Universitaria Di Bologna
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Bologna, BO, Italy
Istituto Clinico Humanitas
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Rozzano, MI, Italy
Centro di Riferimento Oncologico - Unit of Medical Oncology
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Aviano, Pordenone, Italy
Istituto Europeo di Oncologia
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Milano, MI, Italy
Azienda Ospedaliera Universitaria Paolo Giaccone
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Palermo, PA, Italy
Policlinico Universitario Campus Biomedico
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Roma, RM, Italy
Policlinico S.Orsola Malpighi - Unit of Medical Oncology
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Bologna, Italy
Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I
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Roma, Italy
Ospedale San Giovanni Bosco
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Torino, TO, Italy
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
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Candiolo, Torino, Italy
Nuovo Ospedale di Prato
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Prato, Firenze, Italy
Azienda Ospedaliera Universitaria Careggi
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Firenze, Italy