A Phase II Trial of Erlotinib and Radiotherapy in Patients With Stage III Cutaneous Squamous Cell Carcinomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Median Time to Cancer Recurrence
研究概览
简要总结
This is a phase II study designed to study the effectiveness of combined radiotherapy and erlotinib in the postoperative setting for patients with cutaneous SCC that are at high risk for recurrence. Participants enrolled in the study will be evaluated by a head and neck surgeon, and a radiation oncologist. Whenever possible, a preoperative biopsy will be performed after participant enrollment in the study for histological confirmation and for molecular correlates. Participants enrolled prior to surgical resection will begin erlotinib at 150 mg by mouth (PO) every day (QD) (14 tablets) to be taken 14 days prior to surgical resection. Following planned surgical resection, the participant will begin Erlotinib therapy and radiotherapy at the same time and within 4-8 weeks of the surgical resection.
详细描述
This is a single-institution, open-label, non-randomized phase II trial of erlotinib administered concomitantly with radiation therapy following surgical resection of gross disease. A total of 45 patients with previously unirradiated, high-risk cutaneous SCC requiring post-operative radiotherapy will be enrolled to assess the primary endpoints of time to recurrence and disease free survival. Pretreatment biopsies will be required to confirm the histological diagnosis of SCC. Four to six weeks after surgical resection, patients will begin erlotinib (150 mg po qd) beginning the first day of radiotherapy. Patients will receive 5040 cGy beginning on day 1 of therapy in standard fractionations. Patients will be followed to evaluate for toxicity based on NCI common toxicity criteria (v3.0). Patients will be followed on protocol for a minimum of 2 years with regularly scheduled CT scans, clinical evaluations, and laboratory work. Patients with residual or recurrent cancer will be taken off protocol for salvage therapy.
As a secondary objective, molecular response of tumors to erlotinib monotherapy will be determined. When possible, participants will be enrolled and treated for 14 days with erlotinib prior to surgical resection. The pretreatment biopsy specimen (control) will then be compared to tissue acquired during the surgical resection after 14 days of erlotinib (experimental group).
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven primary or recurrent squamous cell carcinoma arising from the lip or skin of the face, ear, scalp or neck.
- •Participants must meet one of the four criteria:
- •T4 cutaneous SCC as determined by physical exam, imaging studies, prior resections or biopsy. T4 disease is defined as tumor that invades deep extradermal structures such as cartilage, skeletal muscle (e.g., muscles of facial expression), parotid gland or bone.Patients with a T2 or greater squamous cell carcinoma of the lower lip who will require post operative radiation will be allowed.
- •Histologically proven regional lymph node involvement (N1 disease). Fine needle aspiration or biopsy can be used to demonstrate the presence of lymphatic spread.
- •Histologically proven parotid gland metastasis. Fine needle aspiration or biopsy can be used to demonstrate the presence of regional spread. Includes delayed regional metastasis; primary scalp or other skin lesion treated within 36 months that would drain into the involved parotid.
- •Patients who following surgical resection of the primary are found to have histologically positive lymph nodes (N1). Includes delayed regional metastasis; primary lip or cutaneous lesion treated within 36 months that would drain into the involved nodal basin.
- •Age > 19 years
- •Tumors must be considered surgically resectable.(Patients may be enrolled after surgery is completed as long as Erlotinib therapy and concurrent radiation is started within 8 weeks of surgical resection.)
- •Required laboratory data obtained prior to beginning treatment: WBC > 1,500/ml; Platelets > 90,000; serum creatinine ≤ 2.0 mg/dl
- •The patient may have had a prior non-cutaneous malignancy, but must be two years from treatment.
- •Performance status of ≤ 2 (ECOG scale) and life expectancy ≥ 12 months.
- •The patients must agree to use effective contraception if there is the potential for procreativity. Contraception must be conducted for at least 3 months following the study.
- •Patients must sign informed consent
排除标准
- •The patient has received prior radiation therapy to the head and neck.
- •The patient is pregnant or lactating
- •Patients with a prior history of head and neck mucosal cancers.
- •Psychological condition that renders the patient unable to understand the informed consent.
研究组 & 干预措施
Erlotinib
Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
干预措施: Erlotinib (Drug)
结局指标
主要结局
Median Time to Cancer Recurrence
时间窗: 2 years
Per protocol, patients were followed every 3 months for recurrent disease by physical exam and imaging (MRI/CT). Recurrence, in most cases, is detected during routine history/physical exam. If disease was detected during follow-up, every attempt was made to obtain pathological confirmation of recurrence.
Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments.
时间窗: 2 years
Number of gradeable toxicities (via CTCAE manual) experienced by patients on this protocol--number of events
Number of Patients With Recurrence at 2 Years
时间窗: 2 years
Rate of recurrence at 2 years.
次要结局
未报告次要终点
研究者
Eben Rosenthal
Professor of Surgery - Otolaryngology
University of Alabama at Birmingham