Status:
UNKNOWN
Treatment Selection According to Skin Reaction to Cetuximab
Lead Sponsor:
Institute of Oncology Ljubljana
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The therapy of patients with locally advanced head and neck cancer will be adjusted to the grade of skin rush as recorded after the first two cycles of Cetuximab and Cisplatin, i.e. either with radioi...
Detailed Description
Background: According to literature, the treatment results in irradiated patients who develop intensive skin reaction after concomitant Cetuximab administration appear improved as compared to the resu...
Eligibility Criteria
Inclusion
- Squamous cell carcinoma, histologically proven (with HPV-status determined in patients with oropharyngeal primary)
- Tumour site: oral cavity, oropharynx, hypopharynx or larynx.
- Locally and/or regionally operable and inoperable tumors (UICC TNM stages III, IVa or IVb), without distant metastases (M0-stage)
- Male or female ≥18 years of age
- Expected survival \>6 months
- 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 (ECC) ≥ 60 ml/minute;
- Presence of at least one bidimensionally measurable index lesion
- Effective contraception for both male and female subjects if risk of conception exists
- Signed written informed consent
Exclusion
- 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
- Chemotherapy ineligibility:
- unstable cardiopulmonary, renal and liver disease likely to compromise the safe delivery of I.V. infusion (chemotherapy); haematologic diseases; clinically evident hearing impairment; pre-existing motor or sensory neurotoxicity grade ≥ 2 according to the CTCAE v3.0; previous administration of Cetuximab or Cisplatin;
- Active, uncontrolled infection
- Medical or psychological condition which in the opinion of the investigator precludes the safe administration of the planned radiotherapy or systemic therapy
- Known drug abuse or severe alcohol abuse
- Pregnancy or breast feeding
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01472653
Start Date
December 1 2011
End Date
December 1 2016
Last Update
December 13 2011
Active Locations (1)
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1
Institute of Oncology Ljubljana
Ljubljana, Slovenia, SI-1000