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A comparison of radiation treatment given 6 days a week versus radiation treatment given 5 days a week along with three-weekly chemotherapy in advanced cancers of the head and neck expressing the EGFR mutation

Concurrent chemoradiation versus accelerated radiation in EGFR positive locally advanced squamous cell carcinoma of the head and neck: A randomized open label clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013311
Enrollment
95
Registered
2018-04-17
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- EGFR overe expressed locally advanced squamous cell carcinoma of head and neck,

Interventions

Intervention1: Accelerated radiation compared with concurrent chemoradiation in head and neck cancer.: Accelerated radiation , i.e , 6 days a week radiation compared with concurrent chemoradiation , i

Sponsors

Government funded institution
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with histology proven EGFR overexpressed squamous cell carcinoma of head and neck region. 2. No previous chemotherapy of radiotherapy for head and neck cancer. 3. No previous surgery except biopsy. 4. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Evidence of systemic metastasis. 2.Histologically other than squamous cell carcinoma. 3. Pregnancy and lactation. 4. Evidence of uncontrolled co-morbidities like uncompensated renal, cardiac, hepatic and respiratory disease.

Design outcomes

Primary

MeasureTime frame
Local controlTimepoint: Local control after 6 weeks of completion of treatment.

Secondary

MeasureTime frame
1. Acute toxicities. 2. Late toxicities 3. Recurrence. 4. Death due to any cause.Timepoint: 1. Acute toxicities - weekly during treatment and 6 weeks after completion of treatment. 2. Late toxicities - every three monthly after 6 months of completion of treatment. 3. Recurrence - every three monthly after 6 months of completion of treatment. 4. Whenever the primary investigator get to know the news of death.

Countries

India

Contacts

Public ContactDr Nibedita Biswas

Medical College Kolkata

asitrdeb@rediffmail.com9830583960

Outcome results

None listed

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