JPRN-jRCT1031230245招募中3 期
JCOG2209: A phase III randomized trial of gross total resection versus possible resection of FLAIR (Fluid Attenuated Inversion Recovery) hyperintensity lesion on MR image for newly diagnosed supratentorial glioblastoma - FLAMINGO
SONODA Yukihiko0 个研究点目标入组 130 人开始时间: 2023年7月19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
- 130
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
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •(1) The preoperative cranial contrast-enhanced MRI satisfies all of the following criteria (a) through (c):
- •(a) The presence of suspected primary glioblastoma.
- •(b) The tumor is located supratentorial (in the cerebrum or diencephalon) and is not found in the cerebellum, brainstem, optic nerves, olfactory nerves, or pituitary gland.
- •(c) There is no evidence of multiple lesions or dissemination.
- •(2) Surgical resection can be performed without worsening the significant neurological symptoms, fulfilling all the following criteria (a) through (c)
- •(a) The predicted resection rate of the contrast-enhanced lesion is at least 95%.
- •(b) When performing a FLAIRectomy, the predicted resection rate of the FLAIR hyperintense lesion is at least 20%.
- •(c) When performing a GTR (complete resection of the contrast-enhanced lesion), the predicted resection rate of the FLAIR hyperintense lesion is less than 20%.
- •(3) No prior tumor resection, including biopsy, for glioma has been performed.
- •(4) The patient's age at registration is between 18 and 75 years old.
- •(5) The Performance Status (PS) is either 0-2 according to ECOG criteria or PS 3 solely due to tumor-related neurological symptoms (PS must be documented in the medical record).
- •(6) There is no history of chemotherapy or radiotherapy to the head for any cancer.
- •(7) The most recent test results within 14 days prior to registration (the same day of the week, two weeks before registration is acceptable) meet all of the following criteria (a) through (f)
- •(a) Neutrophil count >= 1,500/mm3
- •(b) Hemoglobin >= 8.0 g/dL
- •(c) Platelet count >= 10 x 104/mm3
- •(d) AST <= 120 U/L
- •(e) ALT <= 120 U/L
- •(f) Serum creatinine <= 1.5 mg/dL
- •(8) Written consent has been obtained from the patient to participate in the study. However, suppose the patient can understand and agree to the explanation content but is unable to sign due to neurological symptoms. In that case, a proxy may sign the consent form on behalf of the patient.
排除标准
- •(1) Synchronous or metachronous (within 2 years) malignancies.
- •(2) Infections which needs systemic treatment.
- •(3) Body temperature is higher than 38 degrees centigrade at registration.
- •(4) Severe psychological disease.
- •(5) Continuous systemic corticosteroid or immunosuppressant treatment due to the diseases except for brain tumor.
- •(6) Uncontrollable diabetes mellitus.
- •(7) Unstable angina pectoris, or history of myocardial infarction within 6 months.
- •(8) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest X-p.
- •(9) Gadolinium allergy.
- •(10) Positive HIV antibody.
- •(11) Positive HBs antigen.
- •(12) Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding. Men who wish for their partners to become pregnant.
研究者
相似试验
招募中
3 期
JCOG2207: A phase III randomized controlled trial comparing total mesorectal excision and lateral lymph node dissection plus adjuvant chemotherapy with total neoadjuvant therapy followed by total mesorectal excision and selective lateral lymph node dissection for the patients with locoregionally advanced low rectal cancerRectal cancerJPRN-jRCTs031230415OHUE Masayuki420
招募中
3 期
JCOG2107E: A randomized phase III trial comparing etoposide plus carboplatin combination therapy with/without durvalumab (MEDI4736) for advanced neuroendocrine carcinoma of the digestive systemneuroendocrine carcinoma of the digestive systemJPRN-jRCT2031230456Morizane Chigusa74
招募中
3 期
JCOG2215: A randomized controlled phase III trial comparing endoscopic balloon dilation alone versus endoscopic balloon dilation with local triamcinolone injection for esophageal stricture after endoscopic submucosal dissection for esophageal cancerEsophageal stricture after endoscopic submucosal dissection for esophageal cancerJPRN-jRCTs031230645Yano Tomonori260
招募中
2 期
JCOG2203: A randomized controlled phase II/III trial of neoadjuvant chemotherapy for Japanese patients with esophagogastric junction adenocarcinomaJPRN-jRCTs031230182KUROKAWA Yukinori460
招募中
3 期
JCOG1904: A randomized controlled phase III trial of comparing local field with additional prophylactic irradiation in chemoradiotherapy for clinical-T1bN0M0 esophageal canceresophageal cancerJPRN-jRCTs031200067TSUSHIMA Takahiro176