study of combination of Radiation treatment and chemotherapy in advanced Cancer of Head & Neck.
- Conditions
- Health Condition 1: null- Patients of Advanced stage Head and Neck carcinoma. having Squamous cell carcinoma.
- Registration Number
- CTRI/2014/09/004980
- Lead Sponsor
- Biocon Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 536
1.Histologically confirmed Squamous Cell Carcinoma of Head and Neck in advanced stage [stage III or IVA ,B)] considered to be suitable for concurrent chemoradiotherapy.
2. Written informed consent has been obtained
3.Karnofsky Performance Status (KPS) > 70
4.Adults of either sex, between 18 years and above with a life expectancy of at least 6 months.
5.Adequate hematologic function (Absolute Neutrophil Count (ANC) >= 1,500 cells/µL; Hemoglobin > 9 g/dL, platelets > 100,000/µL and <= 500,000/µL)
6.Adequate renal function (serum creatinine <= 1.5 mg/dL or calculated creatinine clearance >= 45 ml/min)
7.Adequate hepatic function [bilirubin <= 1.5 x ULN (upper limit of normal), alanine amino transferase (ALT) <= 5 x ULN, aspartate amino transferase (AST) <= 5 x ULN]
8.Female patients must have a negative urine pregnancy test at pre-study (not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)
9.All patients of reproductive potential must agree to use an approved form of contraception
1.Nasopharyngeal, salivary glands, nasal cavities, maxillary sinus, paranasal sinus squamous cell carcinoma
2.Patients with a history of prior malignancy other than non-melanoma skin cancer or cervical cancer in-situ
3.Patients who have had immunotherapy
4.Patients who have received radiotherapy to head & neck
5.Known or suspected hypersensitivity to compounds with similarity to BIOMAb EGFR for eg. trastuzumab.
6.Patients with distant metastases
7.Pregnant or lactating women
8.Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
9.Known infection with HIV or Active viral hepatitis
10.Prior therapy that specifically and directly targets the EGFR pathway
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the Progression Free Survival to a combination of intravenous BIOMAb-EGFR® (Nimotuzumab), cisplatin and radiotherapy in subjects with advanced [Stage III or IVA, B], histologically documented SCCHN.Timepoint: At the end of the study
- Secondary Outcome Measures
Name Time Method 1. Locoregional Response at 24 weeks from visit of randomization (V2) <br/ ><br>2. Locoregional Control <br/ ><br>3. Overall Survival, <br/ ><br>4. Assessment of quality of life by filling EORTC questionnaire <br/ ><br>Timepoint: 1. Locoregional response at 24 weeks from Randomization <br/ ><br>2. Locoregional control at 2 years <br/ ><br>3. Overall survival at points of Interim analysis 3.5 years and at 5 years <br/ ><br>4. QOL Assessment at every visit. <br/ ><br>