FIG / TROG 18.06
Prospective, multicentre trial evaluating O-(2-[18F]-fluoroethyl)-L-tyrosine Positron Emission Tomography in Glioblastoma (FET-PET in Glioblastoma)
Trial summary:
The FIG trial is investigating how the addition of FET-PET imaging to standard MRI imaging affects radiation target volume delineation and treatment planning for Glioblastoma, as well as determining the accuracy and management impact of FET-PET in distinguishing pseudoprogression from true tumour progression and / or tumour recurrence.
Receptor status / problem studied:
Inclusion criteria
1) Age greater than or equal to 18 years.
2) Histologically confirmed newly diagnosed histologically confirmed GBM IDH1 wild type or IDH1 mutant via IHC (2016 WHO grade IV glioma) following surgery, with methylated or unmethylated MGMT promoter gene.
NOTE: Patients who had previous grade I-III glioma and have progressed to GBM are eligible assuming that they have not received prior cranial radiotherapy or Temozolomide for the treatment of glioma
3) ECOG 0-2.
4) Life expectancy of greater then 12 weeks.
5) Adequate bone marrow reserve or organ function to allow Temozolomide (TMZ) -based chemotherapy.
6) Available tissue for MGMT and biomarker analysis.
7) Participants capable of childbearing are using adequate contraception.
8) Willing and able to comply with all study requirements, including treatment, timing and/or nature of required imaging and study assessments.
9) Signed, written and informed consent.
Group 1 participants:
|— a) Considered suitable for radiotherapy (with one of the two dose fractionation schedules outlined as below) plus concurrent TMZ followed by adjuvant TMZ.
Group 2 participants (entering study at Imaging time-point 2):
|— a) Are currently undergoing or have recently completed concurrent radiotherapy with TMZ and one of the two dose fractionation schedules ie. 60Gy/30 fractions or 40Gy/15 fractions, and logistically able to be recruited.
|— b) Have commenced adjuvant chemo-radiation 7 weeks from surgery.
|— c) Considered suitable for adjuvant TMZ-based therapy.
Exclusion criteria
All participants:
1) Participants with implanted medical or electronic devices deemed by the MRI radiologist to be a contra-indication to performing a brain MRI scan (e.g. implanted defibrillator, cardiac pacemaker, a cochlear implant, a metallic joint prosthesis, nerve stimulators, metal pins, screws, plates, stents or surgical staples).
2) Any concurrent comorbidities, conditions or illness, including severe infection or medical or psychiatric conditions that may jeopardise the ability of the patient to undergo t procedures outlined in this protocol with reasonable safety or that may compromise assessment of key outcomes.
3) History of another malignancy within 2 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment.
Group 1 participants:
|— a) Prior chemotherapy or recent cranial radiation within the last 2 years
Group 2 participants:
|— b) Patients that have a duration of more than 7 weeks from surgery to the start of RT
Trial Title
FIG / TROG 18.06
Diagnosis
Brain cancer
Type of trial
Collaborative
Type of treatement
Radiation Oncology
Phase
N/A