Prospective, Explorative Trial for the Detection of Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST)Harboring Activating Mutations of CKIT or PDGFRA Pre/Post Surgery or Pre/Under Treatment With a Tyrosine Kinase Inhibitor or Progressive Disease Irrespective of Current or Planned Treatment. An Open-label, Non-randomized, Multicenter Phase IIIb Clinical Trial
18 Years
N/A
Both
Gastrointestinal Stromal Tumors
Trial Information
Prospective, Explorative Trial for the Detection of Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST)Harboring Activating Mutations of CKIT or PDGFRA Pre/Post Surgery or Pre/Under Treatment With a Tyrosine Kinase Inhibitor or Progressive Disease Irrespective of Current or Planned Treatment. An Open-label, Non-randomized, Multicenter Phase IIIb Clinical Trial
Inclusion Criteria:
- Signed written informed consent
- Male or female patients aged >= 18 years
- Histologically confirmed GIST
- Known activating mutation of CKIT or PDGFRA and tissue sample can be provided for
central mutation analysis or mutation status unknown and tissue sample can be
provided for central mutation analysis at baseline
- Routinely planned follow-up visits in no longer than three months intervals (+ 14
days) including local standard of care diagnostic imaging (CT, PET- CT, or MRI)
- At least one GIST lesion that can be measured by CT, PET-CT, or MRI
- Planned surgery of one or more disease manifestations or planned TKI treatment (such
as imatinib or sunitinib) in neoadjuvant or palliative intention or disease
progression irrespective of current/planned treatment
- Life expectancy of at least three months
Exclusion Criteria:
- Wild type sequence for CKIT exon 9, 11, 13, 14, 17, 18 and PDGFRA exon 18
- Tissue sample can not be provided for central mutation analysis
- Surgery of primary or progressive lesions already completed and currently no evidence
of progressive lesions
- Patients currently receiving adjuvant TKI treatment after surgery and no evidence of
progressive lesions
- Patients currently receiving palliative TKI treatment and no evidence of progressive
lesions
- Planned follow-up intervals including CT, PET-CT or MRI at more than three months
intervals (+ 14 days)
- Coexisting medical condition or treatment that could interfere with the ability of
the patient to comply with planned treatment interventions (surgery or TKI treatment)
or regular follow-up visits
- Patients unwilling to or unable to comply with the planned therapeutic intervention
(surgery or TKI treatment) or to comply with the regular follow-up visits including
blood sample collection
- Pregnancy and lactation
- Presence of chronic inflammatory diseases, autoimmune diseases, or liver cirrhosis
- Known HIV and/or hepatitis B or C infection
- Other malignancies within the past 3 years except for adequately treated carcinoma of
the cervix and basal or squamous cell carcinoma of the skin
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Percentage of patients with histologically proven GIST, measurable lesion in imaging and activating CKIT and PDGFRA mutation, where detection of tumor specific DNA encoding for mutated CKIT or PDGFA is possible in the plasma at least at one timepoint
Safety Issue:
No
Principal Investigator
Nikolas von Bubnoff, PD Dr.
Investigator Role:
Study Chair
Investigator Affiliation:
Klinikum rechts der Isar
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
CSTI571BDE78T
NCT ID:
NCT01462994
Start Date:
November 2011
Completion Date:
June 2015
Related Keywords:
- Gastrointestinal Stromal Tumors
- Patients with GIST treated with standard therapy harboring activating mutations of CKIT and PDGFRA
- Gastrointestinal Stromal Tumors
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