A Phase II Study Of Submandibular Salivary Gland Transfer To The Submental Space Prior To Start Of Radiation Treatment For Prevention Of Radiation-Induced Xerostomia In Head And Neck Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 12
- 主要终点
- Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"
研究概览
简要总结
RATIONALE: Moving a salivary gland out of the area that will undergo radiation therapy may protect the gland from side effects of radiation therapy and may prevent xerostomia (dry mouth).
PURPOSE: Phase II trial to study the effectiveness of salivary gland surgery in preventing xerostomia in patients who are undergoing radiation therapy for head and neck cancer.
详细描述
OBJECTIVES:
- Determine the reproducibility of the surgical technique of submandibular salivary gland transfer in patients with head and neck cancer.
- Determine the rate and severity of radiation-induced xerostomia after this surgery in these patients.
- Determine the pattern of recurrence, disease-free survival, and overall survival of patients treated with this surgery followed by radiotherapy.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo surgical transfer of the submandibular salivary gland to the submental space.
Within 4-6 weeks after surgery, patients undergo radiotherapy once daily, 5 days a week for 5 ½ to 7 weeks in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •DISEASE CHARACTERISTICS:
- •One of the following diagnoses:
- •Histologically confirmed, previously untreated squamous cell carcinoma of the oropharynx, hypopharynx, or larynx
- •Head and neck cancer of unknown primary with unilateral metastases to the neck nodes
- •No N3 disease
- •No carcinoma of the oral cavity or nasopharynx
- •No bilateral neck node involvement
- •No suspicious neck node on the contralateral neck or the side chosen for salivary gland transfer by CT scan or MRI
- •No pre-epiglottic space involvement
- •No involvement of level 1 nodes on either side of the neck
- •No salivary gland malignancy
- •No recurrent disease
- •PATIENT CHARACTERISTICS:
- •At least 18 years old
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Hemoglobin at least 10 g/dL
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No salivary gland disease (e.g., Sjögren's syndrome)
- •No other malignancy within the past 3 years except basal cell or squamous cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •More than 3 years since prior chemotherapy
- •No prior or concurrent neoadjuvant chemotherapy
- •Concurrent adjuvant chemoradiotherapy (in addition to study radiotherapy) allowed
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Chemotherapy
- •No prior radiotherapy to the head and neck
- •No concurrent intensity-modulated radiotherapy
- •Not specified
- •No concurrent cholinergic drugs
- •No concurrent anti-cholinergic drugs
- •No concurrent tricyclic drugs
- •No concurrent prophylactic amifostine or pilocarpine during and for at least 3 months after completion of study radiotherapy
排除标准
- 未提供
研究组 & 干预措施
Surgery + Transfer + Radiation
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
干预措施: salivary gland transfer (Procedure)
Surgery + Transfer + Radiation
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
干预措施: Post-operative radiation therapy (Radiation)
结局指标
主要结局
Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"
时间窗: At the time of the submandibular salivary gland transfer
Surgery will be scored as "per protocol prescription" if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery "per protocol prescription", then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%.
次要结局
- Overall Survival Rate at 2 Years(From registration to two years)
- Percentage of Patients With Normal Functioning Transferred Submandibular Gland(Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks))
- Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire(Baseline and one year)
- Percentage of Patients Experiencing Facial Edema Following Surgery(From surgery to 30 days after surgery)
- Percentage of Patients Experiencing Late Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy(From 91 days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 5.6 years.)
- Disease-free Survival Rate at 2 Years(From registration to two years)
- Percentage of Patients With Acute Xerostomia(From start of treatment to 90 days)
- Percentage of Patients Experiencing Acute Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy or Chemotherapy(From start of radiation therapy to 90 days)