Study in Low Risk Gastrointestinal Stromal Tumor (GISTs)

GIST Clinical Trial

— RetroGIST  

Official title:

Follow-up in Low Risk Gastrointestinal Stromal Tumors (GISTs) - Retrospective Analysis of Clinical Features and Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04599660
• Other study ID #: ISG-RetroGIST LR
• Status: Completed
• Start date: November 25, 2020
• Est. completion date: December 20, 2023

Study information

• Verified date: December 2023
• Source: Italian Sarcoma Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: December 20, 2023
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

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:

• Metastases at diagnosis.

• Previous treatment with imatinib

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors
• GIST

Intervention

Other:
• Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments)
This observational study collects all the treatments received by the patients according clinical practices or experimental trials and therefore includes drug/biological/surgical and any other applicable treatments

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Italian Sarcoma Group

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Casali PG, Abecassis N, Aro HT, Bauer S, Biagini R, Bielack S, Bonvalot S, Boukovinas I, Bovee JVMG, Brodowicz T, Broto JM, Buonadonna A, De Alava E, Dei Tos AP, Del Muro XG, Dileo P, Eriksson M, Fedenko A, Ferraresi V, Ferrari A, Ferrari S, Frezza AM, Gasperoni S, Gelderblom H, Gil T, Grignani G, Gronchi A, Haas RL, Hassan B, Hohenberger P, Issels R, Joensuu H, Jones RL, Judson I, Jutte P, Kaal S, Kasper B, Kopeckova K, Krakorova DA, Le Cesne A, Lugowska I, Merimsky O, Montemurro M, Pantaleo MA, Piana R, Picci P, Piperno-Neumann S, Pousa AL, Reichardt P, Robinson MH, Rutkowski P, Safwat AA, Schoffski P, Sleijfer S, Stacchiotti S, Sundby Hall K, Unk M, Van Coevorden F, van der Graaf WTA, Whelan J, Wardelmann E, Zaikova O, Blay JY; ESMO Guidelines Committee and EURACAN. Gastrointestinal stromal tumours: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv267. doi: 10.1093/annonc/mdy320. No abstract available. — View Citation

D'Ambrosio L, Palesandro E, Boccone P, Tolomeo F, Miano S, Galizia D, Manca A, Chiara G, Bertotto I, Russo F, Campanella D, Venesio T, Sangiolo D, Pignochino Y, Siatis D, De Simone M, Ferrero A, Pisacane A, Dei Tos AP, Aliberti S, Aglietta M, Grignani G. Impact of a risk-based follow-up in patients affected by gastrointestinal stromal tumour. Eur J Cancer. 2017 Jun;78:122-132. doi: 10.1016/j.ejca.2017.03.025. Epub 2017 Apr 24. — View Citation

Gold JS, Gonen M, Gutierrez A, Broto JM, Garcia-del-Muro X, Smyrk TC, Maki RG, Singer S, Brennan MF, Antonescu CR, Donohue JH, DeMatteo RP. Development and validation of a prognostic nomogram for recurrence-free survival after complete surgical resection of localised primary gastrointestinal stromal tumour: a retrospective analysis. Lancet Oncol. 2009 Nov;10(11):1045-52. doi: 10.1016/S1470-2045(09)70242-6. Epub 2009 Sep 28. — View Citation

Joensuu H, Hohenberger P, Corless CL. Gastrointestinal stromal tumour. Lancet. 2013 Sep 14;382(9896):973-83. doi: 10.1016/S0140-6736(13)60106-3. Epub 2013 Apr 24. — View Citation

Joensuu H, Reichardt P, Eriksson M, Sundby Hall K, Vehtari A. Gastrointestinal stromal tumor: a method for optimizing the timing of CT scans in the follow-up of cancer patients. Radiology. 2014 Apr;271(1):96-103. doi: 10.1148/radiol.13131040. Epub 2013 Nov 18. — View Citation

Rossi S, Miceli R, Messerini L, Bearzi I, Mazzoleni G, Capella C, Arrigoni G, Sonzogni A, Sidoni A, Toffolatti L, Laurino L, Mariani L, Vinaccia V, Gnocchi C, Gronchi A, Casali PG, Dei Tos AP. Natural history of imatinib-naive GISTs: a retrospective analysis of 929 cases with long-term follow-up and development of a survival nomogram based on mitotic index and size as continuous variables. Am J Surg Pathol. 2011 Nov;35(11):1646-56. doi: 10.1097/PAS.0b013e31822d63a7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe the most relevant features of follow-up in very-low and low risk GIST patients	Collection of retrospectively imaging characteristics	Change from diagnosis (baseline)
Primary	To describe the most relevant features of follow-up in very-low and low risk GIST patients	Collection of retrospectively imaging characteristics.	At 1 year
Primary	To describe the most relevant features of follow-up in very-low and low risk GIST patients	Collection of retrospectively imaging characteristics.	At 2 years
Primary	To describe the most relevant features of follow-up in very-low and low risk GIST patients	Collection of retrospectively imaging characteristics.	At 3 years
Primary	To describe the most relevant features of follow-up in very-low and low risk GIST patients	Collection of retrospectively imaging characteristics.	At 5 years
Primary	To evaluate the onset of other neoplasms in very-low and low risk GIST patients	Onset of other neoplasm will be recoreded	Chage from baseline (time of diagnosis) at 5 years
Secondary	To assess baseline clinical and disease-specific factors with possible impact on survival analyses.	Collection of clinical symptoms, pathological and molecular characteristics at disease presentation/diagnosis	Every 3 months (Month 3, Month 6, Month 9...) up to 5 years
Secondary	Recurrence-free survival (RFS)	Time elapsed form the treatment (any) start and the onset of recurrence	Every 3 months (Month 3, Month 6, Month 9...) up to 5 years
Secondary	Post-recurrence progression-free survival (PR-PFS)	Time elapsed form the onset of 1st progression to a further progression	Every 3 months (Month 3, Month 6, Month 9...) up to 5 years
Secondary	Disease-Specific survival (DSS)	Time elapsed for the diagnosis to the death of disease	at 5 years
Secondary	Overall survival (OS).	Time elapsed for the diagnosis to the death for any cause	at 5 years