JPRN-jRCTs071200046进行中（未招募）2 期
A phase II study of additional effect of palliative radiotherapy combined with immune check point inhibitors plus chemotherapy for patients with advanced non-small-cell lung cancer. - SPIRAL-F
Imaizumi Kazuyoshi0 个研究点目标入组 43 人开始时间: 2020年10月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 43
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients who are histologically or cytologically diagnosed as non-small cell lung cancer.
- •2) Patients with stage III, IV or post-operative recurrence incapable of radical radiation therapy.ng cancer.
- •3) Palliative radiation therapy is planned for lesions where lung field does not fall within the irradiation range. However,palliative radiation therapy for thoracic vertebra/rib metastasis, supraclavicular lymph node metastasis, superior vena cava syndrome shall be allowed.
- •4)The presence or absence of measurable lesions does not matter.
- •5) No meningeal carcinomatosis or spinal metastasis requiring surgery.
- •6) Driver gene mutation is negative in only patients with non-squamous cell carcinoma.It is eligible regardless of the presence or absence of driver gene mutation in cases of squamous cell carcinoma.
- •7) Patients are >=20 years of age (age at the time of enrollment).
- •8)Performance status (ECOG) 0 - 1.
- •9) No pericardial effusion,pleural effusion,and ascites of Grade 3 or higher.
- •10) No surgery with organ resection within 28 days before enrollment.
- •11) No systemic chemotherapy, including treatment for other cancer types within 5 years.
- •12) Main organ function is maintained. The latest test value within 14 days before enrollment (possible on the same day two weeks before the enrollment date) satisfies all the following:
- •1.Number of neutrophils >= 1,500/uL
- •2.Hgb >= 9.0g/dL
- •3.Platelet count >= 10x10^4 /uL
- •4.Total bilirubin <= 1.5 mg/dL
- •5.AST (GOT) <= 100 U/L
- •6.ALT (GPT) <= 100 U/L
- •7.Serum creatinine <= 1.5 mg/dL
- •8.SpO2(Room air)>=92%
- •However, if pemetrexed is scheduled to be administered, creatinine clearance >= 50 mL/min should be confirmed.
- •13) Patients without history of complication of autoimmune disease or chronic or recurrent autoimmune disease.
- •14) Prognosis of 3 months or more is expected.
- •15) Patients providing the written informed consent.
排除标准
- •1) Patients with active double cancer.
- •2) Patients with infectious disease requiring systemic treatment.
- •3) Patients with findings of interstitial pneumonia and pulmonary fibrosis that are difficult to undergo chemotherapy.
- •4) Patients who are difficult for the participation in the study by complication of mental disease or psychiatric symptom.
- •5) Pregnant women, lactating women, women who may be pregnant at present, or women who are not willing to use contraception. Male patients who want their partner to become pregnant. However, lactating women shall be allowed if they can be weaned.
- •6) Patients with continuous systemic administration of steroids or immunosuppressants other than anti-edema measures for autoimmune diseases and brain/spinal cord metastases.
- •7) Patients with uncontrollable diabetes mellitus and hypertension, which are poorly controlled by proper treatment.
- •8) Patients with complication of unstable angina pectoris (angina pectoris onset within latest 3 weeks before enrollment or with progression of spasm) or anamnesis of myocardial infarction within 6 months
- •9) HBs antigen positive.
- •10) History of hypersensitivity to cisplatin, carboplatin, pemetrexed, paclitaxel, pembrolizumab, albumin.
- •11) Any other patients who are regarded as unsuitable for this study by the investigators.
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