Evaluation of 18F-MISO-PET detectable changes in proliferation and dispersion of hypoxic subvolume in head and neck cancer in patients undergoing radio(chemo)therapy

Phase 2

Recruiting

• Conditions: Squamous cell carcinoma of the head and neck; C04; C09; C01; C10; C13; C32; Malignant neoplasm of base of tongue; Malignant neoplasm of floor of mouth; Malignant neoplasm of tonsil

• Registration Number: DRKS00003830
• Lead Sponsor: Klinik für Strahlenheilkunde, Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Histo - or cytologically secured squamous cell carcinoma of the oral cavity, hypopharynx or larynx
• Stage III / IV (M0)
• ECOG performance status 0 or 1
• Two-dimensionally measurable tumor> = 2cm in at least one dimension
• Age> = 18 years
Adequate hematologic function • (Hb> 9 g / dl, platelets> = 100X 10 9 / l, ANC> = 1.5 X 10 9 / L)
• Adequate renal function (creatinine - clearance> = 50 ml / min)
• Adequate liver function (AST, ALT and total bilirubin <= 2X ULN)
• Adequate metabolic function (including Mg> = LLN)
• Written consent

Exclusion Criteria

Previous anti-EGFR antibody therapy or treatment with small molecule tyrosine kinase inhibitors
• Previous surgery, chemotherapy or radiation for in the relevant study malignancies
• Prophylactic tracheostomy
• Other known clinically significant diseases (cardiovascular, pulmonary, infections such as HIV, HCV, HBV, ...)
• Pregnant or lactating women
• To provide each type of disability, which affects the compliance or ability of the patient, written consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- changes in PET detected tumor hypoxia in week 0, week 2 and week 5 of radiochemotherapy by evaluation of SUV and hypoxic subvolumes<br>- changes in MRT detected perfusion, diffusion and oxygenation in week 0, week 2 and week 5 of radiochemotherapy by evaluation of ADC, ktrans

Secondary Outcome Measures

Name	Time	Method
- Clinical Follow-ups in addition to radiographic diagnostic to determine overall survival, local tumour control, distant metastasis; point of time: every 3 months in the first 2 years and controls in form of routine follow ups for 5 years<br>- comparison of 3-Tesla-MRI and FMISO-PET/CT scans to establish methods for defining hypoxic subvolumes