ISRCTN87356938Completed未知
Radiotherapy (intensity-modulated radiation therapy [IMRT]), Erbitux® And CHemotherapy for unresectable carcinomas of head and neck
niversity of Heidelberg (Germany)0 sites60 target enrollmentStarted: June 26, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
2012 Interim results article in http://www.ncbi.nlm.nih.gov/pubmed/22472064 interim results 2010 Protocol article in https://pubmed.ncbi.nlm.nih.gov/21108850/ (added 02/11/2022)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Signed written informed consent
- •2. Aged 18 to 70 years, either sex
- •3. Life expectancy of at least six months
- •4. Ability of subject to understand character and individual consequences of clinical trial
- •5. Histologically confirmed locally advanced (stage III or IV), non-metastatic squamous cell carcinoma of the oro-, hypopharynx or larynx (T2-4, NX,M0)
- •6. Oral cavity or oro- or hypopharynx as the primary tumour site
- •7. At least one uni-measurable lesion according to the Response Evaluation Criteria In Solid Tumours (RECIST) criteria
- •8. Karnofsky Performances Status greater than 70%
- •9. Adequate bone marrow function:
- •9.1. Neutrophils greater than 1.5 x 10^9/L
- •9.2. Platelets greater than 100 x 10^9/L
- •9.3. Haemoglobin greater than 10.0 g/dL
- •10. Adequate liver function:
- •10.1. Bilirubin less than 2.0 g/dL
- •10.2. Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), alkaline phosphatase (AP), gamma-glutamyl transferase (gGT) less than 3 x upper limit of normal (ULN)
- •11. Adequate renal function: serum creatinine less than 1.5 mg/dL
- •12. Negative serum/urine beta-human chorionic gonadotropin (B-HCG) test in women of childbearing potential
- •13. Women of childbearing potential: willingness to use effective contraceptive method, defined as the concomitant use of either an intrauterine pessary (IUP) or contraceptive pill and in both cases, condoms for the treatment duration and two months thereafter. Women of non-childbearing potiential are those who are post-menopausal for at least one year or sterilised
- •14. Men of procreative potential: willingness for effective prevention of procreation, defined as a use of condoms and a use of an intrauterine pessary (IUP) or a contraceptive pill by his partner for the treatment duration and two months thereafter
- •15. Subject?s consent to collect blood samples for proteomics and genomics analysis. If a patient does not consent, no blood samples for proteomics and genomics will be taken. Nonetheless, he/she may be enrolled in the study.
Exclusion Criteria
- •1. Previous chemotherapy, radiotherapy or surgery for carcinoma of the head and neck
- •2. Nasopharyngeal carcinoma
- •3. Prior exposure to epidermal growth factor receptor (EGFR) pathway targeting therapy
- •4. Other serious illness or medical conditions:
- •4.1. Unstable cardiac disease despite treatment
- •4.2. Congestive heart failure New York Heart Association (NYHA) grade 3 and 4
- •4.3. Significant neurologic or psychiatric disorders including dementia or seizures
- •4.4. Active disseminated intravascular coagulation
- •4.5. Other serious underlying medical conditions which in the opinion of investigator could impair the ability of the patient to participate in the study
- •4.6. Symptomatic peripheral neuropathy Common Toxicity Criteria (CTC) grade 2 or higher
- •4.7. Ototoxicity CTC grade 2 or higher, except if due to trauma or mechanical impairment due to tumour mass
- •5. Participation in other interventional trials within the last 30 days
- •6. Surgery within the last 30 days
- •7. Known allergic/hypersensitivity reaction to any drugs scheduled for the study treatment
- •8. Women: pregnant or breast-feeding
- •9. Known drug abuse
- •10. Other previous malignancy within five years, with exception of a history of a previous, adequately treated, basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- •11. Legal incapacity or limited legal capacity
- •12. Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Investigators
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