A Phase II Study To Assess The Efficacy of Amifostine for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment With Intensity- Modulated Radiation Therapy (IMRT) for Parotid Salivary Sparing
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- 12-month Clinically Relevant Salivary Flow (CRSF)
研究概览
简要总结
Primary Objective:
To determine if amifostine in combination with IMRT can mitigate the decrease in production of saliva by the submandibular and sublingual salivary glands in patients with HNSCC.
Secondary Objectives:
- To establish a parotid gland dose volume histogram (DVH) versus measured flow relationship in this patient population:
- When the mean dose is < 24-26 Gy (shift recovery time to left)
- When the mean dose is > 24-26 Gy (DVH shift)
- To observe mucositis in the following lower dose RT areas:
- Upper lip
- Lower lip
- Right cheek
- Left cheek
- Right ventral and lateral tongue
- Left ventral and lateral tongue
- Floor of the mouth
- Soft palate
- Hard palate.
- To observe the incidence and patterns of occipital scalp epilation;
- To observe the incidence of dysphagia using the List Performance Status Scale (LPSS); and
- To further evaluate the safety profile of amifostine in this patient population.
详细描述
Amifostine is designed to protect the cells in normal tissues against the toxicities of chemotherapy and radiation therapy.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study.
Blood (about 2 tablespoons) will be drawn for routine blood tests. Your complete medical history will be recorded. You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate), weight, and height. You will have a dental exam. You will complete a questionnaire that asks questions about dry mouth. In addition, you will be asked questions about your diet and eating habits. This should take no longer than 10 minutes. Also, saliva will be collected by a simple, in-office oral test that measures saliva flow rate over a 5 minute period. Women who are able to have children must have a negative blood (about 1-2 teaspoons) pregnancy test.
If you are found to be eligible to take part in this study, you will receive IMRT Monday -Friday over a 6-7 week period. In addition, 2-3 hours before IMRT, you will also take pre-medications by mouth to prevent potential nausea and skin reactions (anti-nausea & antihistamine), including drinking water.You will receive daily IMRT therapy, excluding weekends and holidays. The radiation dose is designed to conform to the 3-dimensional shape of the tumor by controlling the intensity of the radiation beam to focus a higher radiation dose on the tumor (and not the surrounding normal tissue). Thirty (30) to 60 minutes before every IMRT treatment, you will receive study drug in two injections beneath the skin. IMRT will take about 30 minutes to complete.
Every day that you are receiving IMRT (Monday-Friday), you will be asked about any drugs you are taking and any side effects you are experiencing. Your vital signs will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Adult men and women of at least 18 years of age at the time of patient entry;
- •Women of reproductive potential (defined as being <1 year post-menopausal) must have a negative serum pregnancy test within 7 days of study entry;
- •Men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, use of a condom by the sexual partner or sterile sexual partner) beginning at the time the informed consent is signed, and must agree to continue using such precautions while receiving IMRT through 6 weeks after the last dose of amifostine or RT, whichever is the last therapy discontinued;
- •Patients undergoing definitive or post-operative IMRT as follows:
- •Definitive Patients: Histology confirmed unknown primary T0N1-2bM0 or oropharynx Stage I, II, III, IV (TX, T1-T2, favorable T3 (exophytic) N0-N2b, M0), small volume primary and nodal, not requiring chemotherapy during RT (i.e., induction chemo is acceptable as well as concurrent biological therapy e.g., Cetuximab), squamous cell carcinoma (AJCC Staging of HNSCC). Lymph nodes bilaterally of the neck are at risk for metastatic disease and require irradiation per clinical judgment.
- •Post-operative Patients: Histology confirmed oral cavity, oropharynx, larynx and hypopharynx squamous cell carcinoma (AJCC Staging of HNSCC): *Stage III and IV squamous cell carcinoma treated with surgery as the primary modality requiring post-operative RT, but not receiving concurrent chemotherapy. *Indications for post-operative RT include: unfavorable T3 and T4 primaries, compromised margins, nodal metastases, extracapsular nodal extension, perineural invasion and lymphovascular invasion.
- •Zubrod performance status of 0 or 1
- •Adequate nutritional status as determined by the treating physician in conjunction with consultation with clinical nutritionists, as indicated.
- •Hemoglobin must be greater than or equal to 10 g/dL.
- •At least one parotid should keep a mean RT dose of < 24-26 Gy. If this cannot be achieved on one side, then the contralateral parotid dosing goal is to keep the mean dose as low as possible, typically <15 Gy.
- •It is anticipated that at least one submandibular gland will receive a mean dose >24-26 Gy.
- •Written informed consent and HIPAA authorization obtained from the patient prior to receipt of any study medication or beginning study procedures.
排除标准
- •Evidence of significant wound infection, fistula, or major wound dehiscence at time of patient entry.
- •Carcinomas of the paranasal sinuses, nasopharynx, or N3 at time of patient entry.
- •Presence of prior malignancies <5 years other than non-melanoma skin cancer or cervical, breast or bladder cancer in situ.
- •T3N0 glottic cancer at time of patient entry.
- •Prior chemotherapy for other cancer within less than or equal to 3 years prior to patient entry.
- •Planned concurrent or adjuvant chemotherapy.
- •Less than gross total resection for patients on post-operative RT.
- •Prior head neck irradiation except for localized non-melanomatous cutaneous carcinomas.
- •Salivary gland disease, e.g. Sjogren's disease at time of patient entry.
- •Pregnant or nursing at the time of patient entry or positive serum pregnancy test within 7 days of study entry.
- •Use of pilocarpine or cevimeline during participation in the study.
- •General medical or psychological conditions that might preclude the patient from completion of the study or from understanding and signing the informed consent.
- •Evidence of distant metastases.
研究组 & 干预措施
IMRT + Amifostine
Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
干预措施: Amifostine (Drug)
IMRT + Amifostine
Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
干预措施: Intensity- Modulated Radiation Therapy (Procedure)
结局指标
主要结局
12-month Clinically Relevant Salivary Flow (CRSF)
时间窗: 12 months
Primary endpoint is bilateral, 12-month Clinically Relevant Salivary Flow (CRSF) by the submandibular and sublingual salivary glands, collectively. Saliva production will be quantified using selective quantitative submandibular sialometry (total collection time of 5 minutes). A CRSF is equivalent to production of 0.05 mL of saliva post-radiation in a 5-minute collection period.
次要结局
未报告次要终点