Evaluation of benefit of cisplatin and gemcitabine based NACT followed by dysphagia optimised IMRT with concomitant cisplatin and correlation of clinical outcome with serial EBV DNA titre in locally advanced nasopharyngeal carcinoma.
- Conditions
- Health Condition 1: C113- Malignant neoplasm of anterior wall of nasopharynxHealth Condition 2: C112- Malignant neoplasm of lateral wallof nasopharynxHealth Condition 3: C119- Malignant neoplasm of nasopharynx,unspecifiedHealth Condition 4: C118- Malignant neoplasm of overlappingsites of nasopharynxHealth Condition 5: C111- Malignant neoplasm of posterior wall of nasopharynxHealth Condition 6: C110- Malignant neoplasm of superior wall of nasopharynx
- Registration Number
- CTRI/2020/10/028269
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Carcinoma nasopharynx stage II-IVA.,
Histological proof of nasopharyngeal squamous cell carcinoma (keratinizing squamous cell carcinoma, non-keratinizing squamous cell carcinoma including undifferentiated and poorly differentiated nasopharyngeal carcinoma) confirmed by p40 immunohistochemistry.,
Eastern Cooperative Oncology Group performance status 0-3.,
Absence of any uncontrolled medical comorbidity.
Adequate end-organ functions and bone marrow reserve.,
Negative viral serology markers(HIV, HBsAg, HCV).,
Informed Consent.
ECOG performance status 4.,
Immunocompromised status like HIV sero-positivity, organ transplant recipients, congenital immunodeficiency syndromes.,
Any prior oncologic treatment with surgery, chemotherapy or radiotherapy.,
Any uncontrolled comorbidity which may compromise delivery of protocol defined chemotherapy and radiotherapy e.g., renal disease, hepatic disease, cardiorespiratory disease, diabetes mellitus.,
Other histological types of nasopharyngeal carcinomas eg. neuroendocrine carcinomas., adenocarcinomas, and salivary gland type carcinomas.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method �Response rate to NACT & CRT- complete response, partial response and overall response ratesTimepoint: 1 year and 2 year after completion of treatment
- Secondary Outcome Measures
Name Time Method Assessment of acute & late toxicity profile of RT & chemotherapyTimepoint: 1year;Assessment of serial changes in health-related quality of life parametersTimepoint: 1year;Correlation of treatment response and PFS with serial changes in plasma EBV DNATimepoint: 4 weeks and 12 weeks post treatment;Overall SurvivalTimepoint: 1year;Progression free survivalTimepoint: 1year