Analysis of correlation of genetic factors, and biomarkers markers in laryngeal and pharyngeal cancers

Phase 3

• Conditions: Health Condition 1: null- head and neck cancer

• Registration Number: CTRI/2015/06/005874
• Lead Sponsor: tata Memorial Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 536

Inclusion Criteria

ï??Histologically confirmed Squamous Cell Carcinoma of Head and Neck in advanced stage [stage III or IVA, B)] considered to be suitable for concurrent chemoradiotherapy.

ï?? Written informed consent has been obtained

ï??Karnofsky Performance Status (KPS) > 70

ï??Adults of either sex, between 18 years and above with a life expectancy of at least 6 months.

ï??Adequate hematologic function (Absolute Neutrophil Count (ANC) >= 1,500 cells/µL; Hemoglobin > 9 g/dL, platelets > 100,000/µL and <= 500,000/µL)

ï??Adequate renal function (serum creatinine <= 1.5 mg/dL or calculated creatinine clearance >= 45 ml/min)

ï??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]

ï??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)

ï??All patients of reproductive potential must agree to use an approved form of contraception

Exclusion Criteria

ï??Nasopharyngeal, salivary glands, nasal cavities, maxillary sinus, paranasal sinus squamous cell carcinoma

ï??Patients with a history of prior malignancy other than non-melanoma skin cancer or cervical cancer in-situ

ï??Patients who have had immunotherapy

ï??Patients who have received radiotherapy to head & neck

ï??Known or suspected hypersensitivity to compounds with similarity to BIOMAb EGFR for eg. trastuzumab.

ï??Patients with distant metastases

ï??Pregnant or lactating women

ï??Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)

ï??Known infection with HIV or Active viral hepatitis

ï??Prior therapy that specifically and directly targets the EGFR pathway

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Till date, little efforts have been made to understand the associations of various molecular markers with clinical outcome in head and neck cancers. The present study is comprehensive approach to study the effect of molecular markers of hypoxia, host susceptibility, HPV infection and EGFR status on the treatment response. This will help in understanding the predictive value of these markers singly and in combination.Timepoint: All the patients will be followed up for at least (18 months) and clinical outcome will be recorded (disease free survival and overall survival)molecular markers with clinical outcome in head and neck cancers. The present study is comprehensive approach to study the effect of molecular markers of hypoxia, host susceptibility, HPV infection and EGFR status on the treatment response. This will help in understanding the predictive value of these markers singly and in combination.

Secondary Outcome Measures

Name	Time	Method
Till date, little efforts have been made to understand the associations of various molecular markers with clinical outcome in head and neck cancers. The present study is comprehensive approach to study the effect of molecular markers of hypoxia, host susceptibility, HPV infection and EGFR status on the treatment response. This will help in understanding the predictive value of these markers singly and in combination.Timepoint: All the patients will be followed up for at least (18 months) and clinical outcome will be recorded (disease free survival and overall survival)