Role of Afatinib plus chemotherapy versus chemotherapy alone in treatment of locally advanced oral cancers

A comparative efficacy and safety of Oral Afatinib Targeted therapy plus chemotherapy versus Chemotherapy alone in locally advanced squamous cell cancer of Head and neck region from Tertiary care hospital in central India: A Randomized controlled trial - NIL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082447

Enrollment

Registered

2025-03-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Health Condition 1: C068- Malignant neoplasm of overlappingsites of other and unspecified parts of mouth

Interventions

Intervention1: Oral Afatinib Anti EGFR TKI: Patients with locally advanced oral squamous cell carcinoma will be treated with Oral Afatinib Anti EGFR TKI 40 mg OD daily for 6 weeks along with standa

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with performance status ECOG 0-2 as per WHO PS scale. 2. Cases with squamous cell carcinoma of Head and Neck region 3. Locally advanced head and neck boderline resectable or technically unresectable cancer, AJCC stage 3 and 4. 4. Buccal mucosa primary if the extent of the tumor or peritumoral edema reaches up to or above the level of zygomatic arch. 5. Extension of tumour to the high infratemporal fossa. 6. Tongue or floor of mouth primary, extending up to the vallecula. 7. Disease reaching up to the hyoid bone or up to the high infratemporal fossa. 8. Oral cancers with extensive skin infiltrations.

Exclusion criteria

Exclusion criteria: 1. Patients not willing to take oral chemotherapy 2. Patient suffering from Severe mental illness 3. Patient suffering from other concurrent malignancy 4. Patients having severe swallowing problems 5. Recurrent and residual Head neck cancers 6. Metastatic Head Neck cancers 7. Pregnant and Lactating mother 8. Patients refusing Informed consent

Design outcomes

Primary

Measure	Time frame
Reduction in primary tumour size and secondary nodal size in the group A treated with Afatinib and chemotherapy compared to Group B treated with chemotherapy alone.Timepoint: Assessment will be done at the end of 6 weeks from the start of therapy.	—

Secondary

Measure	Time frame
Safety and efficacy of Afatinib with chemotherapy, adverse drug toxicities, if any.Timepoint: Assessment will be done at the end of 6 weeks from the start of therapy.	—

Countries

India

Contacts

Public ContactDr Sourya Acharya

Datta Meghe Institute of Higher Education and Research

souryaacharya74@gmail.com9511840372

Outcome results

None listed

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