Discontinuation of imatinib in patients with oligo-metastatic gastrointestinal stromal tumor that has become radiologically undetectable with treatment

Phase 1

• Conditions: Gastrointestinal stromal tumour (GIST); Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 20.0Level: PTClassification code 10051066Term: Gastrointestinal stromal tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2016-003774-40-FI
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-18
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Age = 18.
2. 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.
3. >5.0 years of treatment with imatinib for metastatic disease when the breaks in imatinib administration are taken into account.
4. No more than 3 detectable metastases in the liver and/or in the abdomen in imaging of the abdomen and the pelvis during the course of the disease or at surgery.
5. Confirmed metastatic GIST in history by radiology, histology, or both.
6. Macroscopically complete resection of all metastases (either R0 or R1 surgery). Patients who have microscopically infiltrated margins (or suspected microscopical infiltration, R1) are allowed to enter the study. RFA of liver metastasis is allowed in place of surgery. 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.
7. Eastern Co-operative Oncology Group (ECOG) performance status = 2.
8. Patient has provided a written, voluntary informed consent prior to study entry and any study-specific procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 21

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified