Do Selective Radiation Dose Escalation and Tumor Hypoxia Status Impact the Locoregional Tumor Control after Radiochemotherapy of Head & Neck Tumors?

Phase 1

• Conditions: This study tests the hypothesis that the Radiation dose escalation to the macroscopic Tumor improves the locoregional control survival after concomitant chemoradiation over 2 years.As a translational objective the pre-therapeutic [18F]-FMISO PET Imaging of Tumor hypoxia is investigated as a useful croterion for stratification, especially with regard to prediction of improved locoregional Tumor control by dose escalation for further clinical studies.; MedDRA version: 18.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-021139-15-DE
• Lead Sponsor: Technische Universität München Fakultät für Medizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-28
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

•Signed written informed consent
•Age = 18 = 70 years
•Independent of gender
•Independent of race
•ECOG 0 – 2
•Tumor of oral cavity,oropharynx or hypopharynx
•Histology: squamous cell carcinoma
•Curativ etreatment intended
•Tumor is classified as irresectable (see Appendix)
•Woman of child-bearing age: negative pregnancy testin serum
•Contraception in male and female patients and their partners if of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post therapy
•Sufficient bone marrow reserves during 7 days before study inclusion; (leukocytes = 4 x 109/l, absolute no. of neutrophiles (ANC) = 2 x 109/; thrombocyte count = 100 x 109/l; Hemoglobin = 10g/dl)
•adequate liver function during 7 days before study inclusion (total bilirubine = 2,5 x ULN (upper limit of normal), ASAT/ ALAT = 2,5 x ULN, alkaline phosphatase = 2,5 x ULN of the institution’s normal value)
•adequate kidney function during 7 days before study inclusion; serum creatinine = 130 µmol/l; creatinine clearance = 70 ml/min
•all patients should have a dental examination before starting therapy and when necessary be treated, adaptation of a teeth protection bar
•a percutane feeding tube should be applied before start of treatment

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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Patients are not eligible for this study if they fulfill one or more of the following exclusion criteria:
•Infiltration of the mandible and / or larynx
•impaired renal and/ or liver function
•secondary malignancy, unknown primary cancer, nasopharynx cancer or salivary gland cancers
•Metastatic disease
•Another cancer within 5 years of study entry
•Serious concomitant disease or medical condition
•Pregnancy or lactation
•Women of child-bearing potential with unclear contraception (post menopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential)
•previous treatment with chemotherapy, radiotherapy or surgery in head and neck (except an excisional biopsy or biopsy for histology)
•concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
•life expectancy of < 1 year
•contraindications to receive Cisplatin
•social situations that limit compliance with study requirements

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified