A Phase II Study of Transoral Robotic Surgery With Adjuvant Therapy for Surgically Resectable HPV-positive Oropharyngeal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Time to local-regional recurrence (TTLRR)
研究概览
简要总结
Standard-of-care treatment options for oropharyngeal cancer often result in long-term side effects that interfere with normal quality of life. A minimally-invasive transoral robotic surgery (TORS) approach has been developed to operate on the disease site while affecting the surrounding tissue as little as possible. Researchers think that this approach may help to control the disease and avoid such long-term side effects.
The goal of this clinical research study is to learn if minimally-invasive transoral robotic surgery (TORS) can help to control HPV-positive oropharyngeal cancer. Transoral means through the mouth. The TORS approach is called the Intuitive Surgical da Vinci Surgical System.
Researchers also want to learn if this surgery affects participants' ability to speak and swallow.
详细描述
Study Surgery:
If you are found to be eligible to take part in this study, you will be scheduled for surgery. You will receive general anesthesia to make you sleep during the procedure. You will be asked to sign a separate consent form that describes the anesthesia and its risks. If the doctor thinks it is needed, the abnormal area will be looked at with a tube that has a lighted camera on one end (called a laryngoscopy) to check the size of the tumor and to look for any additional cancerous areas.
The tumor will be exposed with standard equipment after the teeth are protected with a dental guard. Using the robotic surgical system, the tumor will be removed.
Your affected lymph nodes will be surgically removed through your neck. The robotic system will not be used for that part of the surgery. The nerve that controls the shoulder, the blood vessel that brings blood back to the heart from the brain and neck, and the major muscle of the front of the neck will all be saved, unless the tumor in the lymph nodes has grown directly into those areas. A drain will be placed before the surgical wound is closed. The drain will usually be removed within a week after surgery.
Based on the results of surgery, you will receive adjuvant therapy (therapy after the surgery). For example, if your surgery does not remove enough of the cancer, you will be referred to receive radiation therapy. There will likely need to be a 1-2 week delay before you can receive radiation therapy. Your doctor will discuss this therapy with you in more detail, including the risks.
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
- •Patients with a previously untreated, T1 or T2, N0-N2b transorally resectable (as determined by the treating surgeon), histologically proven HPV positive, squamous cell carcinoma (SCC) of the oropharynx.
- •Eastern Cooperative Oncology Group (ECOG) PS 0-
- •Age >/= 18 years.
- •Negative serum pregnancy test in females of childbearing potential.
- •Patients must sign a study-specific informed consent form prior to treatment.
排除标准
- •Evidence of distant metastases (below the clavicle) by clinical or radiographic examination.
- •Evidence of any other primary cancers or metastases. Evidence of deep soft-tissue or bony invasion, which would preclude TMIS by clinical and/or radiographic exam.
- •Contraindications to general anesthesia.
- •Patients who have had chemotherapy or radiotherapy to the oropharynx prior to entering the study.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Patients with tumors whose resection would necessitate a free-tissue transfer for reconstruction of the surgical defect.
研究组 & 干预措施
Transoral Robotic Surgery (TORS)
Transoral robotic surgery performed utilizing Intuitive Surgical da Vinci Surgical System. Utilizing robotic surgical system, tumor excised with wide surgical margins of 0.5-1 cm. Functional assessment performed at pre-treatment, within 1-4 weeks post-op from TORS (before adjuvant therapy), and after completion of treatment at the following time points: 6 months (±2 months), 12 months (±2 months), and 24 months (±6 months). Functional measures include video-fluoroscopic examination of swallowing (modified barium swallow [MBS] study) with administration of the Performance Status Scale-Head and Neck (PSS-HN) and MD Anderson Dysphagia Inventory (MDADI) questionnaire.
干预措施: Questionnaires (Behavioral)
Transoral Robotic Surgery (TORS)
Transoral robotic surgery performed utilizing Intuitive Surgical da Vinci Surgical System. Utilizing robotic surgical system, tumor excised with wide surgical margins of 0.5-1 cm. Functional assessment performed at pre-treatment, within 1-4 weeks post-op from TORS (before adjuvant therapy), and after completion of treatment at the following time points: 6 months (±2 months), 12 months (±2 months), and 24 months (±6 months). Functional measures include video-fluoroscopic examination of swallowing (modified barium swallow [MBS] study) with administration of the Performance Status Scale-Head and Neck (PSS-HN) and MD Anderson Dysphagia Inventory (MDADI) questionnaire.
干预措施: Transoral Robotic Surgery (TORS) (Procedure)
Transoral Robotic Surgery (TORS)
Transoral robotic surgery performed utilizing Intuitive Surgical da Vinci Surgical System. Utilizing robotic surgical system, tumor excised with wide surgical margins of 0.5-1 cm. Functional assessment performed at pre-treatment, within 1-4 weeks post-op from TORS (before adjuvant therapy), and after completion of treatment at the following time points: 6 months (±2 months), 12 months (±2 months), and 24 months (±6 months). Functional measures include video-fluoroscopic examination of swallowing (modified barium swallow [MBS] study) with administration of the Performance Status Scale-Head and Neck (PSS-HN) and MD Anderson Dysphagia Inventory (MDADI) questionnaire.
干预措施: Modified Barium Swallow (MBS) (Procedure)
结局指标
主要结局
Time to local-regional recurrence (TTLRR)
时间窗: 6 months after surgery
Primary efficacy endpoint is time to local-regional recurrence (TTLRR). TTLRR measured from surgery (using minimally-invasive Transoral Robotic Surgery (TORS)) date to first date that local-regional recurrence disease is objectively documented or to last follow-up date if local-regional recurrence has not occurred during follow-up.
次要结局
未报告次要终点