JPRN-jRCT1080221121已完成3 期
Randomized controlled trial of S-1 versus docetaxel in patients with non-small cell lung cancer who have received a platinum-based treatment.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,154
研究概览
简要总结
It was demonstrated that the non-inferiority of S-1 to standard docetaxel therapy in terms of OS in patients with advanced, previously treated NSCLC.
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)Histologically or cytologically proven NSCLC.
- •2)Locally advanced or metastatic NSCLC (Clinical Stage IIIB/IV, according to TNM classification ver.7) for which curative radiotherapy is not indicated.
- •3)Age of 20 years or older at entry.
- •4)ECOG performance status 2 or less.
- •5)Measurable or non-measurable lesions ( A lesion confirmed with objective evidence such as CT, MRI images, or X-ray taken within 21 days before randomizatzation, regardless of its measurability). Patients with only pleural effusion can not be registered.
- •6)Progression or recurrence after the last treatment is confirmed by radiological image. Previous treatments should include at least one platinum-based regimen. The number of previous regimens must be 3 or less for whom EGFR-TKI (gefitinib/erlotinib) was administered, or 2 or less for whom EGFR-TKI was not administered for metastatic disease.
- •Adjuvant chemotherapy is counted as one regimen if the disease recurred within a year after the completion of postoperative adjuvant chemotherapy, or within a year after surgery in patients given preoperative adjuvant chemotherapy.
- •7)Ability to take drugs orally.
- •8)Adequate major organ functions within 7 days before randomization, as defined
- •Neutrophil count >= 2,000/mm3
- •Platelet count >= 100,000/mm3
- •Hemoglobin >= 9.0 g/dL
- •AST =< 2.5 x ULN
- •ALT =< 2.5 x ULN
- •Total bilirubin =< 1.5 x ULN
- •PaO2 >= 60 Torr or SpO2 >= 94%
- •CCr measured or estimated by the Cockcroft-Gault formula >= 60 ml/min.
- •9)Written informed consent
排除标准
- •1)Previous treatment with docetaxel or fluoropyrimidine.
- •Patient who experienced recurrence more than one year after completion of postoperative adjuvant chemotherapy with tegafur-uracil capsules/granules (UFT) will be eligible.
- •2)Chemotherapy within 4 weeks and/or EGFR-TKI within 2 weeks before the initial administration of the study drug.
- •3)Curative radiotherapy within 6 weeks before the initial administration of the study drug. Palliative local radiation within 2 weeks before the initial administration of the study drug.
- •4)Major surgery within 4 weeks and/or surgical incision within 2 weeks before the initial administration of the study drug.
- •5)Symptomatic brain metastasis(Patients with known asymptomatic brain metastasis is allowed for registration if they are clinically stable and no treatment is required).
- •6)Pleural, peritoneal, or pericardial effusion requiring treatment.
- •7)Active infection requiring administration of systemic treatment with antibiotics, e.g., body temperature rose higher than 38 degree centigrade.
- •8)Patients with Grede 2 or higher diarrhea.
- •9)Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis (except documented radiation pneumonitis) or pulmonary fibrosis, poorly-controlled diabetes, cardiac failure, renal failure, liver failure, active gastrointestinal ulceration, myocardial infarction within 6 months, and Grade3 or higher angina.
- •10)Patients with autoimmune disease requiring treatment with an immunosuppressive agent such as azathiopurine, chlorambucil, cyclophosphamide, ciclosporin, methotrexate, and steroids.
- •11)Active double cancer (synchronous cancer, or metachronous cancer with less than 5 years of disease-free interval), except in situ cervical cancer cured by local treatment, gastric or colon cancer curatively resectable with endoscopy, and resectable non-melanoma skin cancer.
- •12)Confirmed or possible pregnancy, lactation, willingness to become pregnant (for women), or willingness to have a child (for men).
- •13)Psychiatric disorder or symptom that makes participation of the patient difficult.
- •14)Continuous systemic administration of a steroid (oral or intravenous).
- •15)History of severe hypersensitivity reaction to polysorbate 80, or to tegafur-uracil capsules/granules (UFT).
- •16)Current use of flucytosine.
- •17)Participation in other registration trial within one month before randomization in this trial.
- •18)Caucasian
- •19)Physician concludes that the patient's participation in this trial is inappropriate.
研究者
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