NCT00002702Unknown3 期
Multicentre Randomised Trial of Inductive and Adjuvant Perilymphatically Injected Proleukin (rlL-2) in The Treatment of Operable Primary Squamous Cell Carcinoma of The Oral Cavity and Oropharynx
European Institute of Oncology14 个研究点 分布在 1 个国家目标入组 260 人开始时间: 1992年9月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 260
- 试验地点
- 14
- 主要终点
- Disease-free survival at 3 and 5 years
研究概览
简要总结
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells of the mouth or oropharynx. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not known whether giving interleukin-2 with surgery and radiation therapy is more effective than surgery and radiation therapy alone.
PURPOSE: This randomized phase III trial is studying surgery and radiation therapy alone to see how well they work compared to surgery, radiation therapy, and interleukin-2 in treating patients with cancer of the mouth or oropharynx.
详细描述
OBJECTIVES:
- Compare the disease-free and overall survival in patients with previously untreated squamous cell carcinoma of the oral cavity or oropharynx treated with resection with or without and neoadjuvant and adjuvant perilymphatic interleukin-2 (IL-2) and radiotherapy.
- Compare the response rate in patients treated with these regimens.
- Determine the local and systemic effects of locoregional IL-2 on host-tumor interaction and immune properties in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and tumor stage (T2, N0-2 vs T2, N3 or T3-4, N0-3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo induction comprising interleukin-2 (IL-2) via perilymphatic injections to the ipsilateral myelohyoid muscle and insertion of the sternocleidomastoid muscle on days 1-5 and 8-12. Within 10 days after the last IL-2 injection, patients undergo en bloc resection of the primary tumor and corresponding lymphatic drainage area and pre-study margins. Beginning within 4 weeks after surgery, patients with T2, N0-3 disease but with pathohistological evidence of node invasion or capsular rupture of node metastasis or T3-4, N0-3 disease undergo adjuvant radiotherapy 5 days a week for 4.5-6.5 weeks. Beginning within 4 weeks after surgery or radiotherapy (if applicable), patients receive adjuvant IL-2 via perilymphatic injections to the contralateral myelohyoid muscle and insertion of the sternocleidomastoid muscle on days 1-5. Adjuvant IL-2 continues monthly for at least 1 year in the absence of disease progression.
- Arm II: Patients undergo resection and radiotherapy (if eligible) as in arm I. Patients are followed monthly for 1 year and then every 2 months for 2 years.
PROJECTED ACCRUAL: A total of 260 patients (130 per treatment arm) will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven squamous cell carcinoma of the oral cavity or oropharynx
- •Operable, primary, unilateral, stage T2-4, N0-3, M0 disease
- •No high probability of bilateral lymphatic spread (requirement for bilateral neck dissection)
- •No tumor involvement of the following sites:
- •Pterygopalatine fossa
- •Carotid artery
- •Maxillary sinus
- •Facial skin
- •Anterior floor of the mouth
- •Base of the tongue infiltrating more than 1 cm
- •Measurable or evaluable disease by physical exam and/or noninvasive imaging
- •PATIENT CHARACTERISTICS:
- •75 and under
- •Performance status:
- •ECOG 0-2 OR
- •Karnofsky 70-100%
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC at least 4,000/mm3
- •Platelet count at least 60,000/mm3
- •Hematocrit at least 30%
- •Bilirubin normal
- •Hepatitis B surface antigen negative
- •Creatinine normal
- •Cardiovascular:
- •No congestive heart failure
- •No uncontrolled hypertension
- •No coronary artery disease
- •No serious arrhythmia
- •No evidence of prior myocardial infarction on ECG (stress test required if in doubt)
- •HIV negative
- •No autoimmune disease
- •No contraindications to pressor agents
- •No serious infection requiring antibiotics
- •No other concurrent primary malignancy
- •Not pregnant or nursing
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior or other concurrent immunotherapy
- •Chemotherapy:
- •No prior or concurrent chemotherapy
- •Endocrine therapy:
- •No prior or concurrent hormonal therapy
- •No concurrent corticosteroids
- •Radiotherapy:
- •No prior radiotherapy
- •See Disease Characteristics
- •No prior major organ allografts
- 另有 3 项未显示
排除标准
- 未提供
结局指标
主要结局
Disease-free survival at 3 and 5 years
Recurrence/metastasis rate at 3 and 5 years
Response rate
Local and systemic effects of treatment
次要结局
未报告次要终点
研究者
研究点 (14)
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