FindTrial
Sign In

Comparison of two radiation treatment schedules to reduce symptoms in advanced head and neck cancer patients

Comparison of two palliative hypofractionated Radiotherapy schedules in patients of advanced Head and Neck Squamous cell Carcinoma - a single institutional prospective randomized study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049783
Enrollment
40
Registered
2023-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: PALLIATIVE HYPOFRACTIONATED RADIOTHERAPY SCHEDULES: COMPARISON OF TWO PALLIATIVE HYPOFRACTIONATED RADIOTHERAPY SCHEDULES IN ADVANCED HEAD AND NECK SQUAMOUS CELL CANCER Intervention2: QU
3.5 gray per fraction
2 fractions per day atleast 6 hours apart
cycle to be repeated after 2 weeks Control Intervention1: Standard Palliative Radiation: 30 gray in 10 fractions over 2 weeks
3 gray per fraction

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Age between 18 to 80 years -Histopathologically diagnosed as squamous cell carcinoma -Cancer of head and neck involving the following sub-sites:- o Oral cavity o Oropharynx o Hypo-pharynx o Larynx -De-novo or recurrent / refractory cases -Clinically stage group III to IVC (AJCC 8th Edition) -ECOG PS 0 to 3 -Deemed unsuitable for surgery / inoperable in a multidisciplinary tumour board -Calculated life expectancy > 90 days -Baseline Haemoglobin >9 gm/dl, ANC > 1500/µl, platelets > 1,00,000/µl -Creatinine Clearance >30 ml/min -Written informed consent

Exclusion criteria

Exclusion criteria: -Histopathology other than squamous cell carcinoma -Pregnancy and lactation -Uncontrolled severe comorbidities -Severe dyselectrolytaemia -Sub-sites other than Oral cavity, Oropharynx, Hypo-pharynx and Larynx -Major psychiatric illness making the patient incapable of following medical advice -Prior head and neck radiotherapy within the last 6 months -Prior head and neck surgery within the last 3 months -Concomitant or prior chemotherapy / targeted therapy / immunotherapy within the last 2 weeks -Inability to receive palliative radiotherapy due to patient’s clinical condition, positional or immobilization issues or other reasons -Unwillingness to undergo palliative radiotherapy -Refusal to provide informed consent

Design outcomes

Primary

MeasureTime frame
QUAD SHOT IS AN EFFECTIVE PALLIATIVE REGIMEN FOR ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA.Timepoint: AT BASELINE, DAY 3, DAY 7, DAY 28, SUBSEQUENTLY IN EVERY MONTHS.—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactDR DEBAPRIYO HALDER

DEPARTMENT OF RADIOTHERAPY

drabhishekbasu@yahoo.com9830303459

Outcome results

None listed

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