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Treatment Outcome of Head and Neck Cancer Patients with Extranodal Extension treated with Advanced Radiotherapy and Chemotherapy

Treatment Outcome of Patients with Regionally Advanced Head and Neck Squamous Cell Carcinoma with Clinical Extranodal Extension Treated with Definitive Chemoradiation: A Prospective Single-Arm Study - N3B

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/10/096230
Enrollment
45
Registered
2025-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: C139- Malignant neoplasm of hypopharynx,unspecified Health Condition 2: C329- Malignant neoplasm of larynx, unspecified Health Condition 3: C109- Malignant neoplasm of oropharynx,unspecified

Interventions

Intervention1: Nil: Nil

Sponsors

Department of Radiation Oncology BBCI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed inoperable SCC of oropharynx, hypopharynx, or larynx with cN3b nodal status. 2. ECOG performance 0–1 3. Age 18–70 years 4. Written Informed Consent Obtained

Exclusion criteria

Exclusion criteria: 1. Nodal disease with skin ulceration/fungation/bleeding 2. Prior Radiotherapy for head and neck area 3. Deranged renal function at baseline (Creatinine Clearance less than 50 ml/min) 4. Cases with radiological evidence of Cartilage or Bony Erosion 5. Baseline Non-Functional Larynx based on FEES Test 6. Unable to come for follow-up as per study protocol

Design outcomes

Primary

MeasureTime frame
To assess the progression-free survival (PFS) at 2 year Timepoint: To assess the progression-free survival (PFS) at 2 year—

Secondary

MeasureTime frame
To estimate treatment related toxicities during radiotherapy, at completion and at every follow up using CTCAE 5.0 scale During and at the end of Radiotherapy- Oral mucositis, Dermatitis, Dysphagia, Acute Xerostomia, Neutropenia, Thrombocytopenia, Anaemia, Electrolyte imbalance At follow ups- Xerostomia, Subcutaneous Fibrosis, Dysphagia Timepoint: ;To measure the QOL using instruments (Validated QOL Instruments) EORTC QOL tool QLQ-C30 Quality of Life of Cancer Patients (in English and Assamese) QLQ-H&N35 specific for Head and neck cancer (In English and Assamese) Patient reported HRQOL will be recorded at baseline and at 3 months,6 months and 1 year after completion of Radiotherapy. Timepoint: at baseline, 3 months, 6 months, and 1 year post RT completion;To estimate various prognostic factors associated with treatment response eg. Age, Gender, Size of the Node, T-stage, HPV status for oropharyngeal primary, history of smoking, alcohol consumption etc.Timepoint: ;to estimate the Patterns of Failure:- 1. Locoregional Failure 2. Distant Metastases Timepoint:—

Countries

India

Contacts

Public ContactDr Jyotiman Nath

Dr. B. Borooah Cancer Institute, Guwahati, Assam

jyotimannath@gmail.com9401512763

Outcome results

None listed

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