JPRN-jRCTs031180007已完成2 期
JCOG1311: Randomized Phase II/III Trial of Conventional Paclitaxel and Carboplatin with/without Bevacizumab versus Dose-dense Paclitaxel and Carboplatin with/without Bevacizumab in Stage IVB, Recurrent, or Persistent Cervical Carcinoma - CC-TC+/-Bev/ddTC+/-Bev-P2/3
Ishikawa Mitsuya0 个研究点目标入组 122 人开始时间: 2019年3月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
研究概览
简要总结
Dose-dense, weekly paclitaxel plus carboplatin is not promising for metastatic or recurrent cervical carcinoma.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- Female
入选标准
- •1) Uterine cervical cancer histologically proven by biopsy to the primary tumor
- •2) Squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix
- •3) One of the followings:
- •1. primary stage IVB cervical cancer
- •2. the first relapse, progression, or persistent cervical cancer after curative first line treatments
- •3. the second relapse, progression, or persistent cervical cancer after curative second line treatments for the first relapse
- •4) One of the followings:
- •1. There is at least one metastatic lesion outside the pelvic cavity except paraaortic LN and/or inguinal LN
- •2. There is no metastatic lesion outside the pelvic cavity except paraaortic LN and/or inguinal LN and either of paraaortic or inguinal LN has been irradiated
- •3. All lesions are localized inside the pelvic cavity, and some of them have been irradiated
- •5) No prior treatment of the followings was done,
- •1. prior surgical therapy for relapse inside the pelvic cavity with resection of bladder or intestinal tract
- •2. prior chemoradiation twice or more including the first treatment and the treatment for progression or relapse after the first treatment
- •3. prior adjuvant chemotherapy for initial treatment including two or more regimens
- •4. prior systemic chemotherapy for metastatic or relapse regions
- •5. progression during neoadjuvant chemotherapy of taxane-platinum regimen
- •6. relapse or progression within 24 weeks after adjuvant chemotherapy of taxane-platinum regimen
- •6) Certain interval from the last administration of previous treatments as the followings
- •1. 42 days or more after prior chemoradiation
- •2. 21 days or more after prior radiation
- •3. 28 days or more after prior surgical treatment
- •4. 14 days or more after prior adjuvant chemoterapy
- •7) Age: 20 to 75 years
- •8) PS: 0-2
- •9) No bilateral hydronephrosis
- •10) Peripheral motor neuropathy
- •1. <= Grade 1, Peripheral motor neuropathy
- •2. <= Grade 1, Peripheral sensory neuropathy
- •11) Sufficient organ functions with the latest laboratory examination within 14 days before registration
- •12) Normal ECG within 28 days before registration
- •13) Written informed consent
排除标准
- •1) Simultaneous or metachronous double cancers.
- •2) Active systemic infections to be treated.
- •3) Body temperature of 38 or more degrees Celsius
- •4) Women during pregnancy, possible pregnancy, or breast-feeding
- •5) Psychiatric disease difficult to participate in this clinical study.
- •6) Continuous systemic steroid treatment or other immunosuppressive agent
- •7) Uncontrolled diabetes mellitus or routine administration of insulin
- •8) Uncontrolled hypertension
- •9) Unstable angina or prior myocardial infarction within 6 months
- •10) Metastasis to central nerve system with a symptom
- •11) Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema diagnosed with chest CT
- •12) HBs antigen positive, HCV antibody positive, HIV antibody positive
- •13) hypersensitivity to polyoxyethylated castor oil
- •14) hypersensitivity to alcohol
研究者
相似试验
Unknown
2 期
Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical CancerToxicity Due to RadiotherapyCervical CancerNCT01999933Mei Shi600
终止
2 期
Study of Weekly Paclitaxel, Carboplatin and Irinotecan to Treat Lung CancerLung CancerNCT00465907Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins7
已完成
2 期
Phase2 Trial of Carboplatin-Paclitaxel bi-weekly and Bevacizumab combination therapy for Elderly Patients With Nonsquamous Non-Small-Cell Lung Canceronsquamous Non-Small-Cell Lung CancerJPRN-UMIN000006525Shimane University, School of Medicine23
已完成
1 期
A Phase I/II Study of Paclitaxel, Carboplatin and YM155 (Survivin Suppressor) in Subjects With Solid Tumors (Phase I) and Advanced Non-Small Cell Lung Carcinoma (Phase II)Solid TumorsNSCLCNCT01100931National Cancer Institute (NCI)42
已完成
2 期
A Phase II Study of Carboplatin+weekly Paclitaxel+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous, non-small cell lung cancer.JPRN-UMIN000003674Kochi University, School of Medicine, Department of Hematology and Respiratory Medicine43