JPRN-jRCTs031190223招募中3 期
JCOG1807C: Efficacy and safety of durvalumab before and after operation or durvalumab as maintenance therapy after chemoradiotherapy against superior sulcus non-small cell lung cancer - DEEP OCEA
TSUBOI Masahiro0 个研究点目标入组 79 人开始时间: 2020年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 79
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 <= 75age old（—）
- 性别
- All
入选标准
- •(1) Histologically or cytologically (including biopsy) confirmed non-small cell lung cancer.
- •(2) All the following are satisfied (UICC-TNM classification 8th edition).
- •(i) For primary site, chest CT meets any of the following.
- •a. Direct invasion to the apical chest wall
- •b. Direct invasion to subclavian artery or subclavian vein
- •(ii) For regional lymph nodes, satisfy either of the following by chest CT and FDG-PET / CT.
- •b. cN1 and lymph node metastasis to #13 and/or #14
- •c. cN3, same side supraclavicular lymph node metastasis and no lymph node metastasis to contralateral mediastinal, contralateral hilar, ipsilateral/contralateral scalene, #10 #11, #12, cN2 (ipsilateral mediastinal, subcarinal lymph nodes) (#13 or #14 lymph node metastasis is eligible)
- •In b. and c., hilum is not irradiated.
- •(iii) Distant metastasis (including intrapulmonary metastasis within the same lung lobe and ipsilateral lung lobe) is not found in imaging including FDG-PET/CT
- •(3) It is judged that radical resection is possible by lobectomy (including bi-lobectomy)
- •(4) Consult with the radiation oncologist and it is judged that all the following conditions are met.
- •(i) Radiation therapy is possible according to the protocol
- •(ii) The radiation field does not reach the hilar region
- •(5) Over 20 years old and under 75 years old.
- •(6) An Eastern Cooperative Oncology Group performance status (PS) of 0 or 1
- •(7) It does not matter whether or not there are measurable lesions.
- •(8) Whether benign or malignant, there is no history of surgery below.
- •(i) A history of surgery by thoracotomy, thoracoscopy involving the ipsilateral lung, esophagus or mediastinum.
- •(ii)A history of surgery by median sternotomy.
- •(ii) A history of lung resection other than wedge resection of the contralateral lung (whether thoracotomy or thoracoscopic surgery).
- •(9) No history of chemotherapy, including treatment for other cancer types.
- •(10) If patients have a history of radiation therapy including other cancer types, lung, hilar, mediastinum and supraclavicular region are not included in the radiation field.
- •(11) Chest CT does not show interstitial pneumonia or pulmonary fibrosis.
- •(12) No complication of autoimmune disease or a history of chronic or recurrent autoimmune disease.
- •(13) No surgical treatment with general anesthesia within 14 days (2 weeks) before enrollment.
- •(14) Have not received systemic administration of steroids, other immunosuppressants, or immunoglobulin within 28 days (4 weeks) before registration.
- •(15) Sufficient oral intake
- •(16) The latest 12-lead electrocardiogram within 28 days before enrolment shows no ischemic changes.
- •(17) Latest test value within 14 days before enrolment meets all the following.
- •(i) WBC >= 4,000/mm3
- •(ii) hemoglobin >= 11.0 g/dL
- •(iii) platelet count >= 100000/mm3
- •(iv) total bilirubin <= 2.0 mg/dL
- •(v) AST <= 75 U/L
- •(vi) ALT <= 75 U/L
- •(vii) serum creatinine <= 1.2 mg / dL
- •(18) Written informed consent has been obtained from patients themselves regarding study participation.
- •(19) Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
排除标准
- •(1) Having active double cancer (synchronous double cancer / multiple cancer and metachronous double cancer / multiple cancer with disease-free period of 3 years or less.
- •(2) Have an infection including tuberculosis that requires systemic treatment.
- •(3) Body temperature >= 38.0 degrees Celsius at the time of registration.
- •(4) Women who are pregnant, have a possibility of becoming pregnant, fall within 28 days postpartum, or breastfeeding. Men who are planning for conception.
- •(5) Severe mental disease
- •(6) Receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs.
- •(7) Have an uncontrolled diabetes.
- •(8) Have an uncontrolled hypertension.
- •(9) Have a gastrointestinal disease accompanying uncontrollable diarrhea.
- •(10) Have an unstable angina pectoris (angina pectoris with onset or seizure progression within the last 3 weeks) or having a history of myocardial infarction within 6 months.
- •(11) Have an uncontrolled valvular disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, congestive heart failure or arrhythmia.
- •(12) Chest CT shows severe pulmonary emphysema.
- •(13) Positive HBs antigen, HBC angigen or HIV1/2 antigen.
- •(14) The continuous use of flucytosine (Ancotyl) is required.
- •(15) Participated in another clinical trial using the investigational drug for 6 months before enrollment.
- •(16) History of allogeneic organ transplantation.
- •(17) History of active primary immune deficiency.
- •(18) Live vaccine (BCG, polio, measles-rubella mixed, measles, rubella, epidemic parotitis, varicella, yellow fever, rotavirus etc.) within 30 days before registration.
- •(19) Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
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