Oral drug therapy as palliative chemotherapy in Head and Neck cancers

A prospective randomized phase II Study comparing metronomic chemotherapy with chemotherapy (single agent cisplatin),in patients with metastatic, relapsed or inoperable squamous cell carcinoma of Head and Neck

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/07/004791

Enrollment

110

Registered

2014-07-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Metasatatic ,recurrent or locally advanced head and neck cancers deemed unsuitable for loco-regional treatment. Histologically proven squamous cell cancer

Interventions

Intervention1: Oral metronomic chemotherapy: Daily oral celecoxib 200mg BD and oral low dose methotrexate 15mg/m2 weekly till progression of disease or untolerable side effects. Admisitration oral Co

Eligibility

Inclusion criteria

Inclusion criteria: Metasatatic ,recurrent or locally advanced head and neck cancers deemed unsuitable for loco-regional treatment. Histologically proven squamous cell cancer Age group 18-70years Karnofsky performance status more than or equal to 70 Normal pretreatment haemaotological and biochemical parameters as defined below Haemoglobin:8-18mg/dl Absolute Neutrophil count more than 1000/mm3 Total leucocyte count 3000-10,000/mm3 Platelet count -1-4lakhs/mm3 S urea and S creatnine below 45 and 1.2 respectively. Serum Creatinine clearance more than 60 Fasting blood sugar less than 120 Baseline Liver function test within twice the normal limits

Exclusion criteria

Exclusion criteria: Primary in thyroid,salivary gland or nasopharynx patients with significant and uncontrolled comorbid conditions like DM,Hypertension,COPD,active tuberculosis and HIV positive patients Patients who have received cisplatin within last 3 months serological positive for HIV,HCV and HBV

Design outcomes

Primary

Measure	Time frame
Median Progression free survivalTimepoint: Progression free survival at 1 year	—

Secondary

Measure	Time frame
MedianOverall survivalTimepoint: 1 year overall survival	—

Countries

India

Contacts

Public ContactDr Kumar Prabhash

Department of Medical oncology Tata Memorial hospital

vijaypgi@gmail.com9869382266

Outcome results

None listed

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