IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma
- Conditions
- Neoplasms, Squamous Cell
- Interventions
- Registration Number
- NCT00229723
- Lead Sponsor
- AstraZeneca
- Brief Summary
The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg when given either concomitantly or as maintenance to a standard therapy of radiotherapy (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free) rate at 2 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 224
- Histologically or cytologically confirmed stage III or IVA squamous cell carcinoma of the head and neck
- No prior surgery or chemotherapy/biological therapy/radiation therapy
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Life expectancy of more than 12 weeks
- Cancers of the nasal space, oral cavity and larynx; or certain lung diseases.
- Abnormal blood chemistry; uncontrolled respiratory, cardiac, hepatic, or renal disease; or coexisting malignancies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 4 Gefitinib (Iressa) gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy 1 cisplatin Radiation + cisplatin; followed by placebo as maintenance therapy 1 radiotherapy Radiation + cisplatin; followed by placebo as maintenance therapy 2 Gefitinib (Iressa) 250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy 2 cisplatin 250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy 2 radiotherapy 250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy 3 radiotherapy 500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy 3 Gefitinib (Iressa) 500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy 4 radiotherapy gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy 5 cisplatin gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy 5 radiotherapy gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy 5 Gefitinib (Iressa) gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy 6 Gefitinib (Iressa) placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy 6 cisplatin placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy 6 radiotherapy placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy 7 cisplatin placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy 7 radiotherapy placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy 7 Gefitinib (Iressa) placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy 3 cisplatin 500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy 4 cisplatin gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
- Primary Outcome Measures
Name Time Method Local Disease Control Rate at 2 Years Assessed at 2 yrs. Tumour assessments (clinical & by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by Response evaluation criteria in solid tumours (RECIST)). A patient demonstrated local disease control at 2 years if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.
- Secondary Outcome Measures
Name Time Method Local Disease Control Rate at 1 Year Assessed after 1 year. Tumour assessments (clinical and by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by RECIST). A patient demonstrated local disease control at 1 year if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.
Complete Response Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression. A patient was deemed to be a complete responder if the RECIST criteria for complete response were satisfied at any time during the study.
Tumour Response (Complete Response + Partial Response) Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression A patient was deemed to be have a tumour response if the RECIST criteria for complete response or partial response were satisfied at any time during the study.
Progression Free Survival Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression (as defined by RECIST) Percentage of participants who are progression free at 2 years (calculated using the Kaplan-Meier method, which allows for censored observations for example those lost to follow-up). A patient is said to have progressed if they have progression of target or non-target lesions or evidence of any new lesions (as defined by RECIST).
Overall Survival Overall survival assessed at 2 years Percentage of participants who are alive at 2 years (calculated using the Kaplan-Meier method, which allows for patients who do not have complete follow-up (censored observations)).
Safety and Tolerability Assessed over two years
Trial Locations
- Locations (1)
Research Site
🇨🇳Taoynan, Taiwan