Impact of Selective Radiation Dose Escalation and Tumour Hypoxia Status on Locoregional Tumour Control After Radiochemotherapy of HNT

Launched by TECHNICAL UNIVERSITY OF MUNICH · Sep 29, 2010

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treat locally advanced head and neck cancer. Researchers want to find out if giving a higher dose of a specific type of radiation, called Intensity Modulated Radiotherapy (IMRT), to the main tumor and affected lymph nodes can help control the cancer better, especially in areas where the tumor might not be getting enough oxygen (a condition known as hypoxia). By combining this targeted radiation with chemotherapy using a drug called Cisplatin, the team hopes to improve the chances of keeping the cancer from coming back over the next two years.

To participate in this trial, you need to be between 18 and 70 years old and have a specific type of head and neck cancer that cannot be surgically removed. You'll also need to be in relatively good health, with normal blood tests and no other serious medical conditions. If you join the study, you can expect to receive a tailored treatment plan and close monitoring to ensure your safety. The initial phase of the trial will focus on assessing any side effects before moving on to the main study, which aims to provide insights into how to better treat this challenging condition.

Gender

ALL

Eligibility criteria

• 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
• • 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 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 \< 12 months
• • contraindications to receive Cisplatin
• • social situations that limit compliance with study requirements