Status:
UNKNOWN
Impact of Selective Radiation Dose Escalation and Tumour Hypoxia Status on Locoregional Tumour Control After Radiochemotherapy of HNT
Lead Sponsor:
Technical University of Munich
Conditions:
Locally Advanced Head and Neck Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The major clinical problem and predominant cause of death after radio-oncological treatment of H+N cancers are loco-regional relapses. This randomized trial tests the hypothesis that dose escalated In...
Detailed Description
The pre-study with sequential design is a prospective multicentre interventional pilot study to assess toxicity of intensity modulated radiotherapy (IMRT) plus Cisplatin of head and neck cancers The ...
Eligibility Criteria
Inclusion
- 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
- Curative treatment intended
- Tumor is classified as irresectable (see Appendix)
- Woman of child-bearing age: negative pregnancy test in 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
Exclusion
- 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 \< 12 months
- contraindications to receive Cisplatin
- social situations that limit compliance with study requirements
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT01212354
Start Date
July 1 2015
End Date
September 1 2025
Last Update
February 9 2016
Active Locations (1)
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1
Klinik für RadioOnkologie Strahlentherapie
Munich, Bavaria, Germany, 81675