Status:
COMPLETED
Induction Chemotherapy Followed by Chemoradiation With Cetuximab in Head and Neck Cancer
Lead Sponsor:
Institute of Oncology Ljubljana
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 we...
Detailed Description
The treatment results with radiotherapy in inoperable squamous cell carcinoma of the head and neck are poor. In this proposed single-institution non-randomized, one-arm, open label phase II study, th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00868491
Start Date
March 1 2008
End Date
October 30 2011
Last Update
October 18 2024
Active Locations (1)
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1
Institute of Oncology Ljubljana
Ljubljana, Slovenia, SI-1000