Head and Neck Cancer Clinical Trial
Official title:
Induction Chemotherapy Followed by Chemoradiation With Cetuximab and Cisplatin for Inoperable Squamous Cell Carcinoma of the Head and Neck
Verified date | October 2011 |
Source | Institute of Oncology Ljubljana |
Contact | n/a |
Is FDA regulated | No |
Health authority | Slovenia: Ethics Committee |
Study type | Interventional |
The purpose of this study is to determine the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell carcinoma of the head and neck.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2011 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Squamous cell carcinoma, histologically proven - Tumour site: oral cavity, oropharynx, hypopharynx or larynx. - Locally and/or regionally inoperable tumors (UICC TNM stages IVa or IVb) - - without distant metastases (M0-stage) - Male or female =18 years of age - Expected survival >6 months - Presence of at least one bidimensionally measurable index lesion - Effective contraception for both male and female subjects if risk of conception exists - WHO performance status 0-2 - Laboratory parameters: hemoglobin =100 g/L leukocyte count > 3.5x109/L, absolute neutrophil count = 1.5x109/L platelet count > 100x109/L total bilirubin < 1.25x upper normal limit transaminases (ALT, AST) < 5x upper normal limit creatinine clearance = 55 mls/minute - Signed written informed consent Exclusion Criteria: - Metastatic disease - Squamous cell carcinoma of the nasopharynx and nasal cavity and paranasal sinuses - ChT or XRT ineligibility: Unstable cardiac disease or any other medical condition likely to compromise the safe delivery of ChT or XRT; Clinically evident hearing impairment; Pre-existing motor or sensory neurotoxicity grade = 2 according to the CTCAE v3.0; - Any kind of previous therapy for SCCHN (excluding diagnostic biopsy) - Previous administration of EGFR pathway-targeting therapy - Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy which is not part of the study protocol - Participation in another clinical trial within 30 days prior to study entry - Pregnancy or breast feeding - History of severe acute pulmonary disease - Any investigational agent within past 30 days - Other previous malignancy within 5 years, with exception of a history of a previously adequately treated basal cell carcinoma of the skin or pre- invasive carcinoma of the cervix - Known drug abuse / severe alcohol abuse - Legal incapacity or limited legal capacity - Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent - Active, uncontrolled infection - Other medical condition or other therapy that in the opinion of the investigator precludes the safe administration of the planned ChT and XRT |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Slovenia | Institute of Oncology Ljubljana | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
Institute of Oncology Ljubljana |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | locoregional control | at 2 years post-therapy | No | |
Secondary | feasibility (toxicity profile) of the proposed regimen | during therapy | Yes | |
Secondary | complete response rate | after induction ChT and 14-16 weeks after the therapy | No | |
Secondary | disease free survival | at 2 years post-therapy | No | |
Secondary | overall survival | at 2 years post-therapy | No | |
Secondary | late toxicity including thyroid function | up to 2 years post-therapy | Yes |
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