A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 6
- 主要终点
- Quality of Life
研究概览
简要总结
The historical standard treatment for early-stage squamous cell carcinoma of the oropharynx is radiation therapy. Some patients require chemotherapy with the radiation, and some patients require surgery if the tumour or lymph nodes have not responded after radiation.
This study will compare radiation therapy with a new surgical treatment called transoral robotic surgery (TORS). TORS is a new surgical approach using a robot to assist the surgeon in removing the tumour, potentially with fewer side effects than older surgical techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 or older
- •willing to provide informed consent
- •ECOG performance status 0-2
- •Histologically confirmed squamous cell carcinoma primary rumour site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)
- •Tumour stage:T1 or T2, with likely negative resections at surgery
- •Nodal stage: N0, N1, or N2 (less than or equal to 4 cm in maximum dimension in any plane, on either side of the neck), without extranodal extension on pre-randomization imaging.
- •Patient assessed at head and neck multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumour board prior to randomization.
排除标准
- •Serious medical comorbidities or other contraindications to radiotherapy, chemotherapy or surgery
- •Prior history of head and neck cancer within 5 years
- •Prior head and neck radiation at any time
- •Metastatic disease
- •Inability to attend full course of radiotherapy or follow-up visits
- •Neck disease with unknown primary site
- •Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer
- •unable or unwilling to complete QoL questionnaires
研究组 & 干预措施
Radiotherapy plus or minus Chemotherapy
Radiotherapy plus or minus chemotherapy with surgical treatment for salvage of persistent disease
干预措施: Radiotherapy (Radiation)
Transoral Robotic Surgery + Neck Dissection
Transoral robotic excision will be carried out using the da Vinci surgical robot. The spatula cautery will be used to remove the tumours with 1 cm margins. At the time of surgery circumferential margins will be taken and sent for frozen section analysis. The resection will proceed until negative margins are obtained if feasible.
干预措施: Transoral Robotic Surgery + Neck Dissection (Procedure)
结局指标
主要结局
Quality of Life
时间窗: 1-year post treatment
次要结局
- Swallowing Function(5 years from date of first treatment)
- Toxicity(5 years from date of first treatment)
- Overall Survival(At the end of 3 years and at the end of 5 years)
- Progression-free survival(At the end of 3 years and at the end of 5 years)
- Quality of life at other time points(Every 6 months for 5 years from 1st date of treament)
研究者
David Palma
Principal Investigator
Lawson Health Research Institute