Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Treatment-naive patients with clinically and radiologically confirmed node-positive oral squamous cell carcinoma (T1-T4, N+). Nodal involvement is confirmed by CT, MRI, PET-CT along with ultrasound neck in all patients. Age between 18 and 70 years. ECOG performance status 0 or 1 or Karnofsky Performance Score (KPS) of 80 or higher. Subjects must have normal organ and marrow function. Written informed consent obtained in accordance with ICH-GCP guidelines and NDCT 2019 .
Exclusion criteria
Exclusion criteria: Patients with recurrent oral cancers. Bulky nodal disease more than 5 nodes or more than 6 cm in size. Involvement of level IV or V nodes. Any prior neoadjuvant chemotherapy or radiotherapy. Patients unwilling to comply with follow up or treatment protocols.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival (DFS)Timepoint: DFS is defined as the time from surgery until the first recurrence (local, regional, or distant) or death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS)Timepoint: OS is defined as the time from surgery until death from any cause | — |
Countries
India
Contacts
Tieten Medicity Hospital