A Phase III Randomized Controlled Trial of Adjuvant RT Alone Versus Concurrent Chemoradiotherapy After Neoadjuvant Treatment in Borderline Resectable Oral Cavity Cancers (RAdiAN)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 376
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
This is a Phase III randomized controlled trial designed to evaluate whether adjuvant radiotherapy alone is non-inferior to adjuvant chemoradiotherapy in patients with borderline resectable oral cavity squamous cell carcinoma who have received neoadjuvant systemic therapy followed by surgery. Eligible patients will be randomized within eight weeks of surgery to receive either adjuvant radiotherapy alone (60–64 Gy in 30–32 fractions) or adjuvant radiotherapy with concurrent chemotherapy. The primary endpoint is three-year disease-free survival. Secondary endpoints include overall survival, locoregional recurrence-free survival, distant metastasis-free survival, acute and late toxicities, and quality of life outcomes assessed using validated questionnaires. Translational research will be conducted to evaluate molecular biomarkers and imaging correlates of treatment response and toxicity. A total of 376 patients will be enrolled across Tata Memorial Hospital and ACTREC, Mumbai. The study aims to refine postoperative treatment strategies, reduce unnecessary chemotherapy, and improve quality of life without compromising survival outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 and 70 years
- •Karnofsky Performance Score (KPS) not less than 70
- •Biopsy-proven borderline resectable oral squamous cell carcinoma (OSCC)
- •Baseline imaging available
- •Received two or more cycles of neoadjuvant systemic therapy followed by surgery
- •Complete histopathology details available, including: -Tumour size -Grade -Margin status -Depth of invasion -Perineural invasion -Nodal involvement -Extranodal extension -Pathological response to neoadjuvant therapy
- •Fit for concurrent chemotherapy defined by the following thresholds: -Hematological: Absolute neutrophil count (ANC) not less than 1000/µL; Platelet count not less than 100,000/µL -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
- •No active uncontrolled infections or severe comorbidities.
排除标准
- •Positive margins or extranodal extension (ENE) on histopathology, or ENE detected on baseline imaging
- •Recurrent or second primary cancers
- •Prior radiotherapy or chemoradiotherapy
- •Incomplete HPR information
- •Presence of distant metastasis
- •Unresolved grade III or IV toxicities related to neoadjuvant systemic therapy at the time of randomization.
结局指标
主要结局
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.
时间窗: -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
次要结局
- -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.)
研究者
Anuj Kumar S
ACTREC, Tata Memorial Centre