Radiation Therapy Followed by Chemotherapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
The goal of this clinical research study is to learn if radiation therapy and chemotherapy can help control stage 1 and/or 2 NK cell lymphoma. The safety of radiation and chemotherapy will also be studied.
详细描述
The Study Treatments:
Radiation therapy is designed to kill cancer cells or to stop cancer cells from growing.
CHOP chemotherapy is made up of the drugs cyclophosphamide, hydroxydaunorubicin (doxorubicin), oncovin (vincristine), and prednisone. It is designed to help control the tumor locally as well as the tumor cells that might have escaped and moved through the body.
Radiation Therapy:
You will receive radiation therapy 5 days a week for 28 to 30 treatments. You will receive a separate consent form that will describe this procedure and its risks in more detail.
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 with newly diagnosed stage I and II nasal Natural Killer (NK) cell lymphoma.
- •Adequate blood cell counts (i.e. Absolute neutrophil count (ANC)> 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and Epoetin. Epoetin will not be administered concurrently with radiation.
- •Patients must have adequate liver function as indicated by: *Bilirubin </= 1.5 times the upper limit of normal (ULN), * Alanine transaminase (ALT) </= 2 times the (ULN) or aspartate transaminase (AST) ≤ 2 times the ULN, *These values must be obtained within two weeks before protocol entry.
- •Patients are required to have adequate renal function as indicated by a serum creatinine </= 2.5 mg/dL.This value must be obtained within two weeks before protocol entry.
- •Left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure >/= 50%.
- •Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.
- •Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses > two years or surgically sterilized).
- •Female patients of childbearing potential must have a negative serum pregnancy test (BhCG) within 2 weeks of protocol entry.
- •Patients must have the ability to give informed consent.
排除标准
- •Patients with active Hepatitis B and/or Hepatitis C infection.
- •Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
- •Patients known to be HIV positive.
- •Patients with pre-existing cardiovascular disease requiring ongoing treatment. This includes: a) Congestive heart failure class III/IV (CHF) per new york heart association (NYHA) criteria. b) Cardiomyopathy, c) Uncontrolled cardiac arrhythmia, d) Unstable angina pectoris, e) Recent Myocardial infarction (MI) (within 6 months).
- •Patients with prior exposure to anthracyclines:
- •Patients who are pregnant or breast-feeding.
- •Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.
- •Prior radiation to the site of current primary disease, if re-treatment would lead to violation of known radiation dose tolerance limits for that site.
研究组 & 干预措施
Radiation + Chemotherapy
Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
干预措施: Radiation (Radiation)
Radiation + Chemotherapy
Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
干预措施: Cyclophosphamide (Drug)
Radiation + Chemotherapy
Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
干预措施: Doxorubicin (Drug)
Radiation + Chemotherapy
Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
干预措施: Vincristine (Drug)
Radiation + Chemotherapy
Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
干预措施: Prednisone (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Day 1 to disease progression or death (up to 5+ years)
Progression-free survival (PFS) defined as time from treatment initiation day to first documented progressive disease or death due to disease. Reviewed with each 21-day treatment cycle, followed every 3-4 months for first 2 years, annually thereafter.
次要结局
未报告次要终点