EUCTR2007-000741-36-GB
Active, not recruiting
Phase 1
Study of radiotherapy dose escalation with Intensity Modulated Radiation Therapy (IMRT) and synchronous Cetuximab for intermediate stage head and neck cancer - INTENSE
Christie Hospital NHS Trust0 sites28 target enrollmentMarch 29, 2007
DrugsErbitux
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Christie Hospital NHS Trust
- Enrollment
- 28
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A histopathological diagnosis of head and neck squamous cell carcinoma
- •Head and neck subsites of oropharynx, larynx, hypopharynx
- •Requires radiotherapy as primary treatment
- •Stage II (T2N0\)
- •Stage III (T1N1, T2N1, T3N0\)
- •WHO performance status 0\-2
- •Age \= 16 and estimated life expectancy \> 3 months
- •Adequate haematological function: Haemoglobin \= 10g/dl; WBC \= 3\.0 x 109/l; ANC \= 1\.5 x 109/l; platelet count \= 100,000/mm3 (prior transfusions for patients with low haemoglobin allowed)
- •Adequate liver function: total bilirubin \= 1\.5 x ULN; ALT, AST \& ALP \= 1\.5 x ULN
- •Adequate renal function with serum urea \& creatinine \= 1\.5 x ULN.
Exclusion Criteria
- •Head and neck sub\-sites of oral cavity, sinus, nasopharynx, salivary glands, ear
- •Low risk Stage II
- •o Laryngeal glottic carcinoma T2a
- •Previous surgical curative resection for primary tumour
- •Neck lymph nodes clinically or radiologically \>2cm without neck dissection
- •Patients with metastatic disease
- •Previous radiotherapy within treatment field
- •Relative contraindication to radiotherapy
- •Previous administration of EGF monoclonal antibodies, EGFR signal transduction inhibitors or EGFR targeted therapy
- •History of previous malignancy (except cervical carcinoma in\-situ treated by cone\-biopsy/resection, non\-metastatic basal cell carcinomas of the skin, any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously)
Outcomes
Primary Outcomes
Not specified
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