Randomized Phase III Trial to Compare Radiation Therapy Alone With Radiation Therapy and Concomitant Anti-EGFr Antibody (C225) for Locally Advanced Squamous Cell Carcinomas of the Head and Neck
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 3
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if radiation therapy is more effective with or without cetuximab for cancer of the oropharynx, hypopharynx, or larynx.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without cetuximab in treating patients who have stage III or stage IV cancer of the oropharynx, hypopharynx, or larynx.
详细描述
OBJECTIVES:
- Compare the rate of locoregional disease control maintained for 1 year in patients with advanced squamous cell carcinoma of the oropharynx, hypopharynx, or larynx treated with radiotherapy with or without concurrent cetuximab.
- Compare the response rates, progression-free survival and overall survival rates, and quality of life in patients treated with these regimens.
- Compare acute and late toxicity of these regimens in these patients.
- Determine tumor epidermal growth factor receptor levels in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by Karnofsky performance status (60-80% vs 90-100%), nodal stage (N0 vs N+), tumor stage (T1-3 vs T4), and radiotherapy schedule (concurrent boost vs once daily vs twice daily).
Patients are randomized to 1 of 2 treatment arms:
- Arm I: Patients undergo radiotherapy beginning on day 1. Patients are assigned to 1 of 3 radiotherapy groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically proven advanced squamous cell carcinoma of the oropharynx, hypopharynx, or larynx
- •Stage III OR
- •Stage IV without distant metastases
- •Measurable disease
- •Tumor tissue available for immunohistochemical assay of epidermal growth factor receptor expression
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •At least 1 year
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT and SGPT no greater than 2 times upper limit of normal
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 50 mL/min
- •Calcium normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Medically able to withstand a course of definitive radiotherapy
- •No medical or psychologic condition that would preclude informed consent or compliance
- •No other malignancy within the past 3 years except basal cell skin cancer or preinvasive carcinoma of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior cetuximab or other murine monoclonal antibody
- •Chemotherapy:
- •At least 3 years since prior systemic chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy to head and neck
- •No other concurrent radiotherapy
- •No prior surgery for indicator lesion except biopsy
- •Study radiotherapy must not be a part of a postoperative regimen after primary surgical resection
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo radiotherapy beginning on day 1. Patients are assigned to 1 of 3 radiotherapy groups:
- Group 1: Patients undergo concurrent boost radiotherapy comprised of radiotherapy once daily 5 days a week for 3.5 weeks followed by radiotherapy twice daily 5 days a week for 2.5 weeks.
- Group 2: Patients undergo radiotherapy once daily 5 days a week for 7 weeks.
- Group 3: Patients undergo radiotherapy twice daily 5 days a week for 6-6.5 weeks.
干预措施: conventional surgery (Procedure)
Arm I
Patients undergo radiotherapy beginning on day 1. Patients are assigned to 1 of 3 radiotherapy groups:
- Group 1: Patients undergo concurrent boost radiotherapy comprised of radiotherapy once daily 5 days a week for 3.5 weeks followed by radiotherapy twice daily 5 days a week for 2.5 weeks.
- Group 2: Patients undergo radiotherapy once daily 5 days a week for 7 weeks.
- Group 3: Patients undergo radiotherapy twice daily 5 days a week for 6-6.5 weeks.
干预措施: radiation therapy (Radiation)
Arm II
Patients receive a test dose of cetuximab IV over 10 minutes on day 1. Patients who do not experience grade 4 anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30 minutes after completion of test dose. Patients receive maintenance cetuximab IV over 1 hour on day 8. Maintenance cetuximab repeats every week for 7 courses. Beginning on day 8, patients undergo radiotherapy as in arm I concurrently with maintenance cetuximab. There must be an hour interval between the completion of cetuximab infusion and the start of any radiotherapy.
Radiotherapy groups remain the same as in Arm I:
- Group 1: Patients undergo concurrent boost radiotherapy comprised of radiotherapy once daily 5 days a week for 3.5 weeks followed by radiotherapy twice daily 5 days a week for 2.5 weeks.
- Group 2: Patients undergo radiotherapy once daily 5 days a week for 7 weeks.
- Group 3: Patients undergo radiotherapy twice daily 5 days a week for 6-6.5 weeks.
干预措施: radiation therapy (Radiation)
Arm II
Patients receive a test dose of cetuximab IV over 10 minutes on day 1. Patients who do not experience grade 4 anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30 minutes after completion of test dose. Patients receive maintenance cetuximab IV over 1 hour on day 8. Maintenance cetuximab repeats every week for 7 courses. Beginning on day 8, patients undergo radiotherapy as in arm I concurrently with maintenance cetuximab. There must be an hour interval between the completion of cetuximab infusion and the start of any radiotherapy.
Radiotherapy groups remain the same as in Arm I:
- Group 1: Patients undergo concurrent boost radiotherapy comprised of radiotherapy once daily 5 days a week for 3.5 weeks followed by radiotherapy twice daily 5 days a week for 2.5 weeks.
- Group 2: Patients undergo radiotherapy once daily 5 days a week for 7 weeks.
- Group 3: Patients undergo radiotherapy twice daily 5 days a week for 6-6.5 weeks.
干预措施: conventional surgery (Procedure)
Arm II
Patients receive a test dose of cetuximab IV over 10 minutes on day 1. Patients who do not experience grade 4 anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30 minutes after completion of test dose. Patients receive maintenance cetuximab IV over 1 hour on day 8. Maintenance cetuximab repeats every week for 7 courses. Beginning on day 8, patients undergo radiotherapy as in arm I concurrently with maintenance cetuximab. There must be an hour interval between the completion of cetuximab infusion and the start of any radiotherapy.
Radiotherapy groups remain the same as in Arm I:
- Group 1: Patients undergo concurrent boost radiotherapy comprised of radiotherapy once daily 5 days a week for 3.5 weeks followed by radiotherapy twice daily 5 days a week for 2.5 weeks.
- Group 2: Patients undergo radiotherapy once daily 5 days a week for 7 weeks.
- Group 3: Patients undergo radiotherapy twice daily 5 days a week for 6-6.5 weeks.
干预措施: cetuximab (Biological)