Phase 2 Single Arm Trial of Adjuvant Nodal Irradiation Alone in Post Operative Oral Tongue Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 14
- 主要终点
- Rate of Acute Grade ≥3 Oral Mucositis
研究概览
简要总结
This study will test whether limiting standard photon intensity modulated radiation therapy (IMRT) to exclude the oral tongue surgical site can decrease the risk of side effects caused by oral radiation. The researchers will also find out if this approach affects the rate of disease coming back after treatment (recurrence), and will measure participants' quality of life by having them complete questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •* Age ≥ 18
- •* Surgical resection of all gross disease without evidence of residual loco-regional disease on simulation PET/CT.
- •* pT1-2, or pT3 by DOI, pN0-2b Squamous Cell Carcinoma of the Oral Tongue confirmed on final surgical pathology. Patients must have:
- •* at least two of the following pathologic risk features
- •* DOI ≥ 4mm and ≤ 10mm OR
- •* 1 or 2 pathologically positive nodes N1 to low volume N2b. OR DOI \>10 mm OR
- •* \<=cT3N2b who undergo induction with near pCR (\<5% viable) or pCR at primary site
- •* Primary specimen surgical margins ≥3 mm (if \= 2.2mm)
- •* Signed informed consent form by the participant or their legally authorized representative (LAR)
排除标准
- •* N2c/N3 nodal disease
- •* pT3 by size
- •* \>2 pathologically positive nodes
- •* Primary specimen surgical margin \< 3 mm (if \= 2.2mm)
- •* Extensive Perineural Invasion (PNI); non-extensive PNI is permitted.
- •* Extra-capsular extension in any pathologically positive lymph node
- •* Prior or simultaneous invasive malignancy that, in the opinion of the PI, represents a competing risk of death equivalent to the patient's oral tongue squamous cell carcinoma.
- •* Auto-immune conditions that would otherwise preclude radiation in the opinion of the PI (e.g. Scleroderma).
- •* Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.
研究组 & 干预措施
Radiation Therapy
These patients will then receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions). They will be monitored for both physician reported toxicities.
干预措施: Photon intensity modulated radiation therapy (IMRT) (Radiation)
Radiation Therapy
These patients will then receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions). They will be monitored for both physician reported toxicities.
干预措施: Life questionnaire's (Other)
结局指标
主要结局
Rate of Acute Grade ≥3 Oral Mucositis
时间窗: within 120 days of radiation completion
This is defined by CTCAE v 5.0 criteria
次要结局
- Cumulative Incidence of Local Failure(2 years)