NL-OMON43404
Completed
Not Applicable
Prognostic and predictive value of 18F-fluoroazomycin arabinoside-PET/CT in head and neck squamous cell carcinoma - 18F-FAZA-PET/CT in head and neck cacer
St. Luc University Hospital; Université Catholique de Louvain0 sites60 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- squamous cell carcinoma of the head and neck
- Sponsor
- St. Luc University Hospital; Université Catholique de Louvain
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients randomized in any of the two arms of EORTC 1219 trial
- •No contraindication to FAZA\-PET/CT: pregnant or breast\-feeding woman; for woman subject of childbearing potential, a pregnancy test will be done within 72 hours before the examination.
- •Patients must be scanned on a PET/CT scanner accredited, and in compliance with the provided imaging guidelines.
- •Biopsy must be performed 2 weeks before imaging scans.
- •Patient must have given written informed consent to participate to the imaging sub\-study.
- •Additional eligibility criteria for the imaging sub\-study
- •Delay between the baseline scan (FAZA\-PET/CT) and the start of the radiotherapy \< 7 days.
- •Patients with at least one measurable lesion at baseline defined as a lesion larger than 2 cm in diameter.;Inclusion criteria EORTC 1219 trial:
- •\* Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
- •\* Newly diagnosed tumors classified as stage III\-IV located in the larynx, oropharynx and hypopharynx
Exclusion Criteria
- •The same as the EORTC 1219 trial:
- •\* Patients who have received treatment with any investigational drug substance within 4 weeks prior to randomization.
- •\* Current participation in any other interventional clinical study.
- •\* Pregnant or breast\-feeding female patient. Pregnancy test should be done within 72 hours from treatment start.
- •\* Female subjects of childbearing potential (defined as a sexually mature woman who 1\) has not undergone a hysterectomy or bilateral oophorectomy or 2\) has not been naturally post\-menopausal (amenorrhoea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (i.e. has had menses at any time in the preceding 12 consecutive months)) not willing to use adequate contraception during study and for 6 month after last dose of study drug.
- •\* Male subjects not willing to use condoms throughout study drug therapy, and for 6 months after cessation of study therapy if their partner is of childbearing potential and has no contraception.
- •\* Known or suspected HIV infection.
- •\* Second malignancies in the 3 years prior to study entry with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin.
- •\* Uncontrolled or chronic bacterial, fungal or viral infection.
- •\* Known or suspected hypersensitivity to component(s) of investigational product or cisplatin contraindication.
Outcomes
Primary Outcomes
Not specified
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