Effectiveness of incorporating cetuximab into both docetaxel/cisplatin/fluorouracil induction chemotherapy and chemoradiotherapy in inoperable squamous cell carcinoma of the oral cavity
- Conditions
- Oral Squamous Cell CarcinomaCancer
- Registration Number
- ISRCTN13782908
- Lead Sponsor
- Taipei Veterans General Hospital
- Brief Summary
2017 results in https://pubmed.ncbi.nlm.nih.gov/28370774/ (added 12/05/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 43
1. Aged between 18-70 years
2. Histologically proven locally advanced inoperable stage IV oral squamous cell carcinoma (OSCC)
3. At least one measurable lesion
4. An ECOG performance status < 2
5. Adequate hematological profile (WBC > 3 x 109/L, neutrophils > 1.5 x109/L, hemoglobin > 9 g/dl, platelets > 100 x 109/L)
6. Adequate liver and renal function panel (serum bilirubin < 1.5 x ULN, AST/ALT < 5 x ULN, creatinine < 1.25 x ULN and/or creatinine clearance > 50 ml/min)
7. Life expectancy of more than 12 weeks
8. Effective contraception for both male and female subjects if the risk of conception exists
1. Distant metastasis or locally recurrent tumors
2. Prior chemotherapy, radiotherapy or surgery for HNC
3. Simultaneous double cancers except for cervical carcinoma in situ
4. Localized skin squamous cell cancer, or basal cell carcinoma of the skin
5. Use of an investigational agent within the past 28 days prior to enrollment
6. Known grade 3/4 allergic reactions to any components of the treatment
7. Pregnancy or breast-feeding
8. Clinically active disease unrelated to cancer itself
9. History of severe pulmonary or cardiac disease in the past 12 months
10. Uncontrolled chronic neuropathy
11. Participation in another clinical trial within the past 30 days
12. Legal incapacity or limited legal capacity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method