JPRN-jRCTs031210393招募中3 期
JCOG2002: A randomized phase III study of thoracic radiotherapy for extensive stage small cell lung cancer - yES-TRT study
IHO Seiji0 个研究点目标入组 330 人开始时间: 2021年10月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 330
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
- •Primary registration criteria
- •(1) Cytologically or histologically confirmed small cell lung cancer. class IV or class V was required for cytology.
- •(2) Extensive stage was diagnosed by thoracoabdominal contrast-enhanced CT, FDG-PETand brain contrast-enhanced MRI.Lymph node metastasis exists either the supraclavicular/mediastinal lymph node or the ipsilateral hilar lymph node.
- •(3) Over 20 years old.
- •(4) Performance status 0, 1 or 2.
- •(5) Measureable or non-measureable.
- •(6) No history of radiation therapy or chemotherapy for small cell lung cancer.
- •(i) No prior palliative radiation therapy for non-central nervous system metastases within 7 days
- •(ii) No prior stereotactic irradiation for central nervous system metastases within 7 days
- •(iii) No prior whole-brain irradiation within 14 days
- •(7) No history of radiation therapy with supraclavicular, mediastinal, or hilar for other cancer types.
- •(8) Major organ function is preserved.
- •(i) Neutrophil count >= 1,500 /mm3
- •(ii) Hemoglobin >= 9.0 mg/dl
- •(iii) Platelet count >= 100,000 /mm3
- •(iv) T-bil <=1.5 mg/dL
- •(v) AST =< 100 U/L (=< 200 U/L in case of liver metastases)
- •(vi) ALT =< 100 U/L (=< 200 U/L in case of liver metastases)
- •(vii) Serum creatinine <=1.5 mg/dL
- •(viii) SpO2 >= 92%
- •(9) No active autoimmune disease.
- •(10) No serious tumor-related complications.
- •(11) Written informed consent.
- •Secondary registration selection criteria
- •(1) Primary registration was performed. Four course of ACE therapy or DPE therapy was completed, or only three course of ACE therapy or DPE therapy is completed due to adverse events.
- •(2) Following (i)-(iii) is satisfied.
- •(i) Contrast-enhanced CT after 2 courses of induction therapy does not show obvious progressions compared to CT before primary registration.
- •(ii) Contrast-enhanced CT after 4 courses of induction therapy does not show obvious progressions compared to CT after 2 courses of induction therapy.
- •(iii) No obvious progressions from the start of induction therapy.
- •(3) Within 7-42 days from the start of the final course of induction therapy.
- •(4) Within 64-182 days from the primary registration.
- •(5) Performance status 0 or 1.
- •(6) Judged that radiation therapy for the hilum and mediastinum was possible by consulting with a radiologist.
- •(7) Major organ function is preserved.
- •(i) Neutrophil count >= 1,500 /mm3
- •(ii) Hemoglobin >= 9.0 mg/dl
- •(iii) Platelet count >= 100,000 /mm3
- •(iv) T-bil <=1.5 mg/dL
- •(v) AST =< 100 U/L (=< 200 U/L in case of liver metastases)
- •(vi) ALT =< 100 U/L (=< 200 U/L in case of liver metastases)
- •(vii) Serum creatinine <=1.5 mg/dL
- •(viii) SpO2 >= 92%
- •(8) No drug-induced interstitial pneumonia or pulmonary fibrosis diagnosed by chest CT.
- •(9) No tracheoesophageal fistula, bronchoesophageal fistula, tracheal mediastinal fistula, or bronchial mediastinal fistula.
排除标准
- •(1) Simultaneous or metachronous (within 2 years) double cancers , with the exception of intramucosal tumor curable with local therapy.
- •(2) Active infection requiring systemic therapy.
- •(3) Fever over 38 degrees Celsius
- •(4) Female during pregnancy, within 28 days of postparturition, or during lactation. Male who wants partner's pregnancy.
- •(5) Psychological disorder difficult to participate in this clinical study.
- •(6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
- •(7) Uncontrollable diabetes mellitus.
- •(8) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
- •(9) Interstitial pneumonia or pulmonary fibrosis diagnosed by CT.
- •(10) Positive for HBs antigen.
研究者
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