Adjuvant Radiotherapy in Early Stage Oral Cancers (AREST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 8
- 主要终点
- loco-regional recurrence free survival
研究概览
简要总结
This study will assess the benefit of postoperative adjuvant radiotherapy in patients with an early oral squamous cell carcinoma (OSCC) having tumor thickness more than or equal to 5mm. The study population will consist of patients who have been treated by surgery for early stage oral tongue cancers. Patients with a close or positive margin (</= 5mm) and or with metastatic neck node(s) will be excluded. Selected patients will be randomized into two groups. The group I will be observed after surgery and group II will receive adjuvant radiotherapy as per protocol.
详细描述
The aim of this study is to assess the benefit of postoperative adjuvant radiotherapy in patients with an early oral squamous cell carcinoma (OSCC) having a tumor depth of invasion more than or equal to 5mm.
Primary objective:
To determine the impact of postoperative adjuvant radiotherapy on locoregional recurrence-free survival in patients with early-stage oral tongue cancer with tumor thickness ≥ 5 mm.
Secondary objectives:
- To compare disease-free survival and overall survival between the two groups.
- To assess and compare the quality of life changes between the two groups.
- To assess the acute and long-term radiation toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-operative early stage squamous cell carcinoma of the oral cavity (Oral Tongue, Buccal Mucosa, Floor of mouth). (pT1, pT2, N0 as defined in the AJCC Classification 8th edition.
- •Adequate surgery (Defined as wide local excision of the primary tumor with tumor-free margin ≥ 5mm and ipsilateral selective neck dissection addressing levels I-III at minimum.)
- •Written informed consent.
- •Age ≥18 years
- •Eastern Co-operative Oncology Group (ECOG) Performance Status 0-2
- •The depth of invasion (DOI) ≥ 5 mm.
- •Compliance to therapy and follow-up
- •The interval from surgery to adjuvant radiotherapy ≤ 6 weeks
排除标准
- •pT3/pT4 (as specified in the AJCC 8th edition).
- •Depth of invasion < 5mm.
- •Any neck nodal metastasis with or without extra nodal extension
- •Tumor-free margin < 5 mm
- •Non-squamous histology
- •Pregnant woman
- •Prior h/o any other malignancy in the last five years
- •Prior therapeutic irradiation of the head and neck.
研究组 & 干预措施
Control arm
Patients in this arm will be observed and kept under active follow-up after surgery for the primary.
Study arm
Intervention in the study arm will be in the form of post-operative adjuvant radiotherapy starting within 6-weeks after primary surgery.
干预措施: Post-operative adjuvant radiotherapy (Radiation)
结局指标
主要结局
loco-regional recurrence free survival
时间窗: Date of randomization to loco regional recurrence (date of proven biopsy date) or at the end of 36 months after recruitment of the last participant.
Measures the number of local or regional recurrences in both arm over a defined time frame.
次要结局
- Disease free survival(Calculated as difference of date of randomization to date of first documented recurrence or relapse, second primary or death or at the end of 36 months after recruitment of the last participant.)
- Overall survival(Date of randomization to death from any cause or at the end of 36 months after recruitment of the last participant.)
研究者
Dr. Sudhir Nair
Professor
Tata Memorial Hospital