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 个研究点目标入组 28 人开始时间: 2007年3月29日最近更新: 2019年12月10日

试验速览

暂无简介。

•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.
•Women of child-bearing potential should have a negative pregnancy test prior to study entry
•Women and men of child-bearing potential should be using an adequate contraception method, which must be continued for 3 months after completion of chemotherapy
•Capable of giving informed consent
•Following types of interventions are allowed:
•o Neck dissection for suspicious or clinically involved lymph nodes
•o Tumour excision for diagnostic purpose eg. Tonsillectomy
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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)
•Any disorder likely to impact compliance with the protocol
•Pregnancy or breast feeding
•Use of any experimental drugs (for any indication) in the previous 4 weeks

发起方

Christie Hospital NHS Trust