Image Guided Intensity Modulated Reirradiation With Concurrent Cetuximab in the Treatment of Locoregionally Confined Relapsed Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To estimate the incidence rate of acute and late toxicities associated with combined cetuximab and image guided intensity modulated reirradiation in patients with recurrent squamous cell cancer of the head and neck.
研究概览
简要总结
The standard treatment for head and neck cancer relapses in previously irradiated patients is controversial. Reirradiation has had some success, but many patients still die from their disease. Cetuximab is helpful in relapsed head and neck cancer, and it improves the effectiveness of radiation in some head and neck cancer patients. But, it has not been studied with reirradiation. The purpose of this study is to see the effects, both good and bad, of reirradiation with cetuximab.
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 must have a pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer in the upper aerodigestive tract or a second squamous cell primary. Patients may have experienced more than one recurrence as long as the first recurrence occurred ≥6 months following the end of the prior RT.
- •The recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence).
- •The majority (≥75%) of the tumor volume must have been in areas previously irradiated to ≥45 Gy. The previous irradiation must not exceed a maximum of 75 Gy.
- •Patients must be at least 6 months from prior radiation therapy.
- •If a resection is performed after the diagnosis of recurrence and before enrollment, either microscopic or macroscopic disease must be present (i.e. positive margins or gross residual).
- •Karnofsky Performance Status 60-
- •Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, bilirubin ≤ 1.5 mg/dl, creatinine ≤ 1.5 mg/dl, within 6 weeks prior to registration.
- •Must be able to submit previous radiation records (simulation and portal film if available) in order to assure that cord tolerance is not exceeded.
- •Patients must sign a study-specific informed consent form prior to study entry.
- •The patient must be between the ages of 18 and 75.
排除标准
- •Distant metastases.
- •Completely resected recurrence with negative margins.
- •Other concurrent invasive malignancies.
- •Prior invasive malignancy unless disease free for at least two years (prior in situ malignancies are permissible).
- •Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
- •Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
- •Previous treatment with cetuximab.
研究组 & 干预措施
Radiation and Cetuximab
Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week
Cetuximab 400 mg/m2 of body surface area over a period of 120 minutes day 1 250 mg/m2 of body surface area over a period of 60 minutes weekly during radiation
干预措施: Radiation (Radiation)
Radiation and Cetuximab
Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week
Cetuximab 400 mg/m2 of body surface area over a period of 120 minutes day 1 250 mg/m2 of body surface area over a period of 60 minutes weekly during radiation
干预措施: Cetuximab (Drug)
结局指标
主要结局
To estimate the incidence rate of acute and late toxicities associated with combined cetuximab and image guided intensity modulated reirradiation in patients with recurrent squamous cell cancer of the head and neck.
时间窗: 5 years
次要结局
- To determine the pattern of disease progression in treated patients.(5 years)
- To identify the impact of cetuximab and image guided intensity modulated reirradiation on patients' quality of life.(5 years)
- To estimate the median and one-year, disease-free, and overall survival rates of the treated patients.(5 years)
研究者
Heath Mackley
Associate Professor
Penn State University