Study in Low Risk Gastrointestinal Stromal Tumor (GISTs) (RetroGIST)

• ClinicalTrials.gov Identifier: NCT04599660
• Recruitment Status: Completed
• First Posted: October 23, 2020
• Last Update Posted: September 19, 2022
• Sponsor: Italian Sarcoma Group
• Information provided by (Responsible Party): Italian Sarcoma Group

Study Description

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

Condition or disease	Intervention/treatment
GIST	Other: Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments)

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

Study Design

• Study Type: Observational
• Actual Enrollment: 700 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Follow-up in Low Risk Gastrointestinal Stromal Tumors (GISTs) - Retrospective Analysis of Clinical Features and Outcomes
• Actual Study Start Date: November 25, 2020
• Actual Primary Completion Date: December 30, 2021
• Actual Study Completion Date: December 30, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Low Risk GISTs; 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.	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

Outcome Measures

Primary Outcome Measures :

1. To describe the most relevant features of follow-up in very-low and low risk GIST patients [ Time Frame: Change from diagnosis (baseline) ]
   Collection of retrospectively imaging characteristics
2. To describe the most relevant features of follow-up in very-low and low risk GIST patients [ Time Frame: At 1 year ]
   Collection of retrospectively imaging characteristics.
3. To describe the most relevant features of follow-up in very-low and low risk GIST patients [ Time Frame: At 2 years ]
   Collection of retrospectively imaging characteristics.
4. To describe the most relevant features of follow-up in very-low and low risk GIST patients [ Time Frame: At 3 years ]
   Collection of retrospectively imaging characteristics.
5. To describe the most relevant features of follow-up in very-low and low risk GIST patients [ Time Frame: At 5 years ]
   Collection of retrospectively imaging characteristics.
6. To evaluate the onset of other neoplasms in very-low and low risk GIST patients [ Time Frame: Chage from baseline (time of diagnosis) at 5 years ]
   Onset of other neoplasm will be recoreded

Secondary Outcome Measures :

1. To assess baseline clinical and disease-specific factors with possible impact on survival analyses. [ Time Frame: 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
2. Recurrence-free survival (RFS) [ Time Frame: 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
3. Post-recurrence progression-free survival (PR-PFS) [ Time Frame: 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
4. Disease-Specific survival (DSS) [ Time Frame: at 5 years ]
   Time elapsed for the diagnosis to the death of disease
5. Overall survival (OS). [ Time Frame: at 5 years ]
   Time elapsed for the diagnosis to the death for any cause

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020.

Criteria

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

Contacts and Locations

Locations

Italy

Azienda Ospedaliero-Universitaria Di Bologna

Bologna, BO, Italy, 40139

Nuovo Ospedale di Prato

Prato, Firenze, Italy, 59100

Istituto Europeo di Oncologia

Milano, MI, Italy, 20141

Istituto Clinico Humanitas

Rozzano, MI, Italy, 20089

Azienda Ospedaliera Universitaria Paolo Giaccone

Palermo, PA, Italy, 90127

Centro di Riferimento Oncologico - Unit of Medical Oncology

Aviano, Pordenone, Italy, 33081

Policlinico Universitario Campus Biomedico

Roma, RM, Italy, 00128

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, Torino, Italy, 10060

Ospedale San Giovanni Bosco

Torino, TO, Italy

Policlinico S.Orsola Malpighi - Unit of Medical Oncology

Bologna, Italy, 40138

Azienda Ospedaliera Universitaria Careggi

Firenze, Italy, 50100

Fondazione IRCCS INT Milano

Milano, Italy, 20133

Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I

Roma, Italy, 00144

Sponsors and Collaborators

Italian Sarcoma Group

Investigators

• Study Chair: Giovanni Grignani; giovanni.grignani@ircc.it

More Information

Publications:

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.

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.

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.

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.

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.

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.

• Responsible Party: Italian Sarcoma Group
• ClinicalTrials.gov Identifier: NCT04599660
• Other Study ID Numbers: ISG-RetroGIST LR
• First Posted: October 23, 2020
• Last Update Posted: September 19, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Italian Sarcoma Group:

GIST; Gastro Intestinal Stromal Tumor

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases