Status:
COMPLETED
InductionChemo-Radio-Antibody-Treatment
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Squamous Cell Carcinoma of the Head
Squamous Cell Carcinoma of the Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label, randomized, Phase II-study to evaluate the efficacy of a standard-TPF induction chemotherapy (IC) and an alternative TPF induction chemotherapy followed by radio-antibody-therap...
Eligibility Criteria
Inclusion
- Histologically proven unresectable SCC of the oral cavity, oropharynx and hypopharynx (stage IVA \& IVB)
- Written and signed informed consent
- Karnofsky PS \> 70 %
- Age ≥ 18 years
- Curative treatment intent
- Adequate bone marrow, hepatic and renal functions as evidenced by the following:
- Hematology (Bone marrow):
- Neutrophils \> 2.0 109/L
- Platelets \> 100 x 109/L
- Hemoglobin \> 10 g/dL
- Hepatic function:
- Total serum bilirubin \< 1 time the UNL of the participating center
- ASAT (SGOT) and ALAT (SGPT) \< 2.5 x UNL
- Alkaline phosphatase \< 5 x UNL
- Renal function :
- serum creatinine (SC) \< 120 µmol/L (1.4 mg/dl);
- if values are \> 120 µmol/L, the creatinine clearance should be \> 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows :
- weight (kg) x (140 - age) --------------------------------- K x serum creatinine
- serum creatinine in mg/dL: K = 72 in man K = 85 in woman serum creatinine in µmol/L: K = 0.814 in man K = 0.96 in woman
- • If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing.
- All patients require:
- dental examination and appropriate dental preservation if needed 1 week prior to the beginning of radiotherapy,
- gastric feeding tube and Portal-catheter.
Exclusion
- Other neoplasia within the past 5 years with the exception of a controlled skin cancer or "in situ" cervix cancer
- Unknown primary (CUP), nasopharynx, laryngeal or salivary gland cancer
- Distant metastatic disease (M1)
- Serious co-morbidity, e.g. arteriosclerosis with apoplexy, recent myocardial infarction, high-grade carotid stenoses, unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4, insulin-dependent diabetes mellitus, uncontrolled hypertension, liver cirrhosis (Quick \< 75%, total protein \<3.0 g/dl, bilirubin \>2mg/ml) or kidney insufficiency (creatinine \>1.4 mg/ml, the creatinine clearance should be \> 60 ml/min)
- patients with ASAT or ALAT \> 2.5 UNL associated with alkaline phosphatase \> 5 UNL are not eligible for the study
- Known HIV-infection
- Pregnancy or lactation
- Women of child-bearing potential with unclear contraception
- Previous treatment of the disease with chemotherapy, radiotherapy, EGFR-targeting agents or surgery exceeding biopsy in head and neck
- Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
- Social situations that limit compliance with study requirements
- Deficient dental preservation status or not accomplished wound healing
- Legal incapacity
- Prior accommodation in an institution under officially or judicially orders (§ 40 1 p. 3 No. 4 AMG)
- Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 2 and/or ototoxicity grade 2, except if due to trauma or mechanical impairment due to tumor mass
- Known allergic/hypersensitivity reaction to any of the components of the treatment
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT01181401
Start Date
August 1 2010
End Date
August 1 2015
Last Update
January 31 2019
Active Locations (5)
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1
Charité Universitaetsmedizin Berlin, CVK, CBF
Berlin, Germany, 13353
2
University Medical Center Hamburg - Eppendorf
Hamburg, Germany, 20246
3
Medizinische Hochschule Hannover
Hanover, Germany, 30625
4
Universitätsklinikum Gießen und Marburg
Marburg, Germany, 35043