Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 1-year Locoregional Progression-free Survival (PFS)
研究概览
简要总结
This trial examines survival and toxicity in previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN) treated with radiosurgery and cetuximab and to evaluate the acute and late toxicities associated with the above therapy.
详细描述
Squamous cell carcinoma of the head and neck is the sixth most common malignancy worldwide with approximately 500,000 cases worldwide yearly. There were an estimated 39,250 new cases and 11,000 deaths in the United States in 2005 (Jemal 2005, Spitz MR). Despite major improvements in the treatment of SCCHN in recent years which include the introduction of concurrent chemoradiotherapy as an effective primary or postoperative therapy, the five-year survival rate for patients with SCCHN in the United States and other developed countries remains poor as nearly 50-60% of these patients will die as a direct result of recurrent locoregional disease. This study aims to determine the 1-year progression-free survival (PFS) of previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN) treated with radiosurgery and cetuximab and to evaluate the acute and late toxicities associated with the therapy.
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
- •Histologically proven recurrent squamous cell carcinoma of the head and neck (SCCHN), who has received prior radiotherapy with or without chemotherapy. New primary is allowed if location is in a previously irradiated field. Biopsy is recommended for each recurrence; but is not mandated per study. This will be at the discretion of the principal investigator.
- •Prior radiation dose of at least 60 Gy.
- •Disease confined to locoregional site and can be encompassed in a stereotactic radiosurgery "portal"
- •Tumor must be deemed to be inoperable or unresectable either by clinical or radiographic criteria. These criteria include encasement of great vessels, vertebral invasion or undue peri-operative risk.
- •Prior surgery for recurrent or new SCCHN is allowed in previously irradiated patients. A minimum of 4 weeks should elapse between any surgery and treatment on study. However, high risk pathologic features should be present, such as positive margins, positive lymphadenopathy, perineural or angiolymphatic invasion. Measurable disease must be present for assessment of response.
- •Karnofsky performance status > 60 (ECOG 0-2)
- •Prior treatment with an EGFR Inhibitor is allowed if it was a part of prior curative therapy and was completed at least 30 days prior to commencement of study therapy
- •Any number of prior chemotherapy regimens are allowed
- •Measurable disease on imaging studies (MRI, CT, PET-CT or physical exam)
- •Age > 18
- •Estimated life expectancy > 12 weeks
- •No prior radiation therapy or chemotherapy within 1 month of study enrollment
- •No prior chemotherapy or targeted therapy within the previous 4 weeks
- •ANC > 1000, PLT>75,000, Serum creatinine<2.5 mg/dL, Bilirubin <1.5 x upper limits of normal (ULN)
- •Diabetes must be controlled prior to PET-CT scanning (blood glucose <200 mg/dL)
- •Ability to provide written informed consent
排除标准
- •Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies
- •History of any cancer other than SCCHN (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years.
- •Patients in their reproductive age group should use an effective method of birth control. Patients who are breast-feeding, or have a positive pregnancy test will be excluded from the study
- •Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
- •Concurrent serious infection
- •History of known hypersensitivity to cetuximab or similar agents
研究组 & 干预措施
Cetuximab and stereotactic radiosurgery
干预措施: Cetuximab (Drug)
Cetuximab and stereotactic radiosurgery
干预措施: Stereotactic radiosurgery (Device)
结局指标
主要结局
1-year Locoregional Progression-free Survival (PFS)
时间窗: At 1-year
Progression (response as assessed by subjective interpretation of the first PET-CT) per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) was defined as greater than 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum and longest diameter recorded since the baseline measurements or the appearance of 1 or more new lesion(s). If the measurable disease was restricted to a solitary lesion, the protocol specified that neoplastic nature should be confirmed by cytology and histology.
1-year Local Progression-free Survival (PFS)
时间窗: At 1-year
Progression (response as assessed by subjective interpretation of the first PET-CT) per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) was defined as greater than 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum and longest diameter recorded since the baseline measurements or the appearance of 1 or more new lesion(s). If the measurable disease was restricted to a solitary lesion, the protocol specified that neoplastic nature should be confirmed by cytology and histology.
1-year Distant Progression-free Survival (PFS)
时间窗: At 1-year
Progression (response as assessed by subjective interpretation of the first PET-CT) per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) was defined as greater than 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum and longest diameter recorded since the baseline measurements or the appearance of 1 or more new lesion(s). If the measurable disease was restricted to a solitary lesion, the protocol specified that neoplastic nature should be confirmed by cytology and histology.
次要结局
- Overall Response (OR)(Up to 2 years)
- 1-year Progression-free Survival (PFS)(At 1-year)
- Overall Survival (OS)(Up to 2 years)
- Changes in Tumor Glucose Metabolism(Up to 24 months / post therapy)
- Changes in Tumor Hypoxia.(Up to 24 months; before and after treatment)
- Quality of Life (QoL)(Baseline, 6-8 weeks post-treatment; up to 16 months)
研究者
David A. Clump, MD, PhD
Associate Professor of Medicine
University of Pittsburgh