Gastrointestinal stromal tumour (GIST) MedDRA version: 19.0 Level: PT Classification code 10051066 Term: Gastrointestinal stromal tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives are to study overall survival and the quality of life (QoL) in the patients who discontinue imatinib. Data about response to reinstitution of imatinib after GIST progression will be collected from the hospital records from those patients who restarted imatinib after completion of the study. The exploratory objectives are to study the relationship between study endpoints and circulating biomarkers, relationships between study endpoints and biomarkers in resected tumors prior to study entry, and changes in the blood cell counts and blood biochemistry after stopping imatinib as compared to the baseline values on imatinib, measured at the time of the screening examinations.;Primary end point(s): Progression-free survival (PFS) ;Timepoint(s) of evaluation of this end point: The PFS will be measured from the date of discontinuation of imatinib to the date of first documentation of progression or death (from any cause), whichever occurs first. 1-year PFS in the first 15 patients included. The study is terminated if 10 or more of the 15 patients (=67 %) have progression of disease or withdraws from the study within the first 12 months from the date of study entry. The final analysis will be performed when the patients without an event have a median follow-up time of above 36 months;Main Objective: The primary objective of the study is to document progression-free survival (PFS) in patients who discontinue imatinib after treatment with imatinib for longer than 5 years for oligo-metastatic GIST (= 3 metastases) and who have no detectable overt GIST lesions in CT/MRI imaging following complete surgical resection (R0/R1-resection), radiofrequency ablation (RFA) of the metastases, or following systemic treatment for oligometastatic GIST | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Survival;Timepoint(s) of evaluation of this end point: Overall survival will be measured from the date of discontinuation of imatinib to the dato of death resulting from any cause. The final analysis will be performed when the patients without an event have a median follow-up time of above 36 months | — |
Countries
Finland, Germany, Norway, Sweden
Contacts
Public ContactØyvind Sverre Bruland
Oslo University Hospital
Outcome results
None listed