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.

A phase II study to evaluate the efficacy of cisplatin and gemcitabine based neoadjuvant chemotherapy followed by dysphagia optimized intensity modulated radiotherapy with concomitant cisplatin and correlation of clinical outcome with serial plasma Epstein Barr Virus DNA titre in patients with locally advanced nasopharyngeal carcinoma.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028269

Enrollment

Registered

2020-10-07

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C113- Malignant neoplasm of anterior wall of nasopharynx Health Condition 2: C112- Malignant neoplasm of lateral wallof nasopharynx Health Condition 3: C119- Malignant neoplasm of nasopharynx,unspecified Health Condition 4: C118- Malignant neoplasm of overlappingsites of nasopharynx Health Condition 5: C111- Malignant neoplasm of posterior wall of nasopharynx Health Condition 6: C110- Malignant neoplasm of superior wall of nasopharynx

Interventions

Intervention1: Neoadjuvant Chemotherapy with Cisplatin & Gemcitabine 3 weekly for 3 cycles followed by Dysphagia optimized intensity modulated radiation therapy with concomittant weekly cisplatin for

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Ã¢â?¬Â¢ Response rate to NACT & CRT- complete response, partial response and overall response ratesTimepoint: 1 year and 2 year after completion of treatment	—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr Ahitagni Biswas

AIIMS, New Delhi

dr_ahitagni@yahoo.co.in9013590854

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026