Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
None listed
Sponsors
Tata Memorial Centre
Sun Pharma Science Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 70 years 2. Karnofsky Performance Score (KPS) not less than 70 3. Biopsy-proven borderline resectable oral squamous cell carcinoma (OSCC) 4. Baseline imaging available 5. Received two or more cycles of neoadjuvant systemic therapy followed by surgery 6. Complete histopathology details available, including: -Tumour size -Grade -Margin status -Depth of invasion -Perineural invasion -Nodal involvement -Extranodal extension -Pathological response to neoadjuvant therapy 7. Fit for concurrent chemotherapy defined by the following thresholds: -Hematological: Absolute neutrophil count (ANC) not less than 1000/?L; Platelet count not less than 100,000/?L -Renal: Creatinine clearance not less than 60 mL/min OR serum creatinine not more than 1.5 mg/dL -Hepatic: AST and ALT not more than 2.5 times the upper limit of normal; Total bilirubin not more than 1.5 times the upper limit of normal 8. No active uncontrolled infections or severe comorbidities
Exclusion criteria
Exclusion criteria: 1. Positive margins or extranodal extension (ENE) on histopathology, or ENE detected on baseline imaging 2. Recurrent or second primary cancers 3. Prior radiotherapy or chemoradiotherapy 4. Incomplete HPR information 5. Presence of distant metastasis 6. Unresolved grade III or IV toxicities related to neoadjuvant systemic therapy at the time of randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether adjuvant RT alone is non-inferior to adjuvant CTRT in achieving 3-year DFS in patients with borderline resectable oral cancers treated with neoadjuvant systemic therapy and surgery.Timepoint: -Baseline: Post-surgery, before starting adjuvant therapy -End of RT/CTRT: At 6?7 weeks (completion of adjuvant treatment) -Follow-up (Year 1-2): Every 3 months -Follow-up (Beyond 2 years): Every 6 months till final 3 year DFS assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| -To compare 3-year overall survival (OS), locoregional recurrence-free survival (LRRFS), and distant metastasis-free survival (DMFS) between the two arms. -To assess acute and late toxicities. -To measure quality of life outcomes using the EORTC QLQ-C30, EORTC QLQ-H&N43, and EQ-5D-5L questionnaires. -To assess response to neoadjuvant treatment using molecular biomarkers such as gamma-H2AX, apoptosis markers, and cell cycle analysis. -To correlate molecular markers of response with long-term clinical outcomes. -To evaluate response to neoadjuvant chemotherapy using imaging biomarkers derived from radiomics and machine learning models. -To analyse baseline and interim imaging to assess treatment response and correlate with long-term outcomes across both study arms. -To compare radiation-induced toxicity between the adjuvant radiotherapy alone arm and the adjuvant chemoradiotherapy arm using gamma-H2AX assays.Timepoint: -Primary endpoint (disease-free survival): assessed at 3 years from randomization -Overall survival, locoregional control, and distant metastasis-free survival: assessed at 3 and 5 years -Toxicity: monitored weekly during treatment and at each follow-up visit (every 3 months for 2 years, then every 6 months up to 5 years) -Quality of life: assessed at baseline, end of radiotherapy, and at follow-up visits -Biomarker studies: after neoadjuvant therapy, before radiotherapy, and within 48 hours after completion of radiotherapy -Imaging: baseline, post-neoadjuvant therapy, and annually during follow-up | — |
Countries
India
Contacts
Public ContactAnuj Kumar S
ACTREC, Tata Memorial Centre
Outcome results
None listed