Health Condition 1: C060- Malignant neoplasm of cheek mucosa
Conditions
Interventions
Intervention1: Avoiding prophylactic irradiation to the lymph nodes of the neck in early-stage oral cavity cancers, post adequate neck dissection.: evaluate the feasibility of the omission of elective
Sponsors
TATA MEMORIAL CENTRE DEPARTMENT OF ATOMIC ENERGY CLINICAL TRIAL CENTRE
Eligibility
Inclusion criteria
Inclusion criteria: Buccal mucosa cancers Bucco-alveolar region. Biopsy proven SCC and Any stage pT1-pT4a, pN0/N1 and has undergone adequate margin negative surgery as per institutional protocol. Adequate node dissection of 18 nodes and tumor not crossing the midline. Willing to sign ICF Tongue tumors Well lateralized tumors of the tongue 1-1.5cms from the midline or Tip of tongue involvement on baseline. Biopsy-proven SCC. Any T Stage pT1-pT4a. pN0/N1(except Ia). Has undergone upfront adequate margin negative surgery (as per institutional protocol). Minimum of 18 nodes dissected. No Contralateral node dissection. Willing to sign Informed Consent form (ICF). Age more than 18 years
Exclusion criteria
Exclusion criteria: 2) Exclusion Criteria a) Synchronous /Metachronous tumours b) Unlikely to complete full course RT or follow up visits c) Patients with more than three risk factors such as i. PDSCC ii. Worst pattern of invasion 5 iii. Lymphovascular invasion iv. Perineural invasion d) Previous history of head and neck cancer treated with surgery other than biopsy /FNAC e) Previous history of RT f) No more than 3 comorbidities like diabetes mellitus, hypertension, dyslipidaemia, comorbidities relating to heart such as IHD g) Pregnant nursing mother h) People unable to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Regional Recurrences. 2 years post-treatment: This will be defined as any nodal recurrence (isolated or in combination with local recurrence) occurring in ipsilateral or contralateral levels Ia - X nodal levels (as defined by Gregoire et al.).The regional recurrences will be diagnosed either radiologically or histologically or bothTimepoint: Subjects fulfilling the criteria of inclusion /exclusion, having provided with consent form will be eligible for participation. Duration of enrolment will be for 36 months. Total duration of study will be of 5 years with follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Swallowing function will be assessed using the MDADI scoring system. Local recurrence rate. Regional recurrence rate. Locoregional recurrence rate. Disease free survival. Overall survival rate. Toxicity assessment. Salvage rates of recurrence (surgery/ RT / Systmic therapy).MD Anderson lymphedema scoring systemTimepoint: Follow up will be done every 3 months post treatment, with appropriate, investigational techniques & QOL sheets for the first one year & then every 6 months for the second year. Pt will still be called for regular follow ups post 2 years of follow up. | — |
Countries
India
Contacts
Public ContactDr Pranav Narayan Bishnu
Assistant professor at Tata Memorial Hospital , Mumbai
Outcome results
None listed