SSG XXV: The Stop-GIST Trial; Discontinuation of Imatinib in Patients With Oligo-metastatic GIST

NCT02924714 | Suspended DMC

• 1 other identifier: SSG XXV: Stop-GIST
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The trial "The stop-GIST trial" is an Oslo University Hospital sponsored, prospective, open-label, 1-group, multicenter phase II trial evaluating discontinuation of imatinib in highly selected patients treated with imatinib longer than 5 years for oligo-metastatic GIST (≤ 3 metastases) and who have no detectable overt GIST lesions on CT/MRI imaging following complete surgical resection (R0/R1-resection) or radiofrequency ablation (RFA) of the metastases.

Conditions

Gastrointestinal Stromal Tumor

Keywords

GIST

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Three-year progression-free survival (PFS) after discontinuation of imatinib.

  3 years

Secondary Outcomes (2)

• Overall survival (OS)

  3 years

• Quality of Life (QoL)

  3 years

Study Arms (1)

Discontinuation of imatinib

OTHER

Patients treated with imatinib longer than 5 years for oligo-metastatic GIST (≤ 3 metastases) and who have no longer detectable GIST lesions on CT/MRI imaging following complete surgical resection (R0/R1-resection) or RFA of the metastases are assigned to discontinue imatinib.

Other: Discontinuation of imatinib

Interventions

Discontinuation of imatinib OTHER

Discontinuation of imatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18.
• Morphological and immunohistochemical documentation of GIST (immunostaining for KIT/ (CD117) and/or DOG-1 (anoctamin-1)) must be positive on a tumour sample. Patients with demonstrated mutation in KIT or PDGFRA may be entered to the study despite negative immunostaining for KIT and DOG-1 provided that tumour histology is compatible with GIST.
• Confirmed metastatic disease by radiology, histology, or both in history.
• \>5.0 years of treatment with imatinib for metastatic disease when the breaks in imatinib administration are taken into account.
• No more than 3 detectable metastases in the liver and/or in the abdomen on imaging of the abdomen and the pelvis or at surgery during the course of the disease.
• Macroscopically complete resection of all metastases (either R0 or R1 surgery). Patients who have microscopically infiltrated margins (or suspected microscopical infiltration, R1) are eligible to enter the study. Radiofrequency ablation (RFA) of liver metastases in place of surgery is also allowed. Patients whose oligometastatic disease had disappeared completely so that no remaining target lesion for surgery or RFA can be identified (including absence of residual cyst-like lesions) are allowed to enter the study.
• Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2.
• Patient has provided a written, voluntary informed consent prior to study entry and any study-specific procedures.

You may not qualify if:

• Patients with metastases outside of the abdomen (e.g. in the bones or lungs).
• Not willing to donate tumor tissue and/or blood samples for the molecular studies that aim at predicting of GIST recurrence.
• Presence of a mutation in SDH, or other evidence for SDH deficiency.
• Presence of neurofibromatosis-1.
• R2 resection of the primary tumour or metastasis.
• Patient with inability to grant reliable informed consent.
• Inability to comply with the scheduled follow-up.
• Progressive disease during imatinib or other systemic treatments for GIST, before or after surgery/RFA of the metastases.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

• Hompland I, Bruland OS. Can Imatinib Be Safely Withdrawn in Patients with Surgically Resected Metastatic GIST? Anticancer Res. 2015 Nov;35(11):5759-65.

  PMID: 26503996 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

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

Study Officials

• Heikki Joensuu, MD PhD

  Comprehensive Cancer Center Helsinki

  STUDY DIRECTOR

• Øyvind S Bruland, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in clinical oncology

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 5, 2016
• Study Start: January 1, 2017
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

NO (1)