EUCTR2012-004076-19-ES进行中（未招募）不适用
Randomized double-blind Phase II study comparing 3-weekly carboplatin (AUC 5) + paclitaxel 175 mg/m2 with or without concomitant and maintenance nintedanib (NINTEDANIB) in advanced or recurrent cervical carcinoma. - ENGOT-cx1/BGOG-cx1: 3 weekly Carboplatin/Paclitaxel with or without nintedanib in cervix cancer
Z Leuven / Belgian Gynaecological Oncology Group0 个研究点目标入组 120 人开始时间: 2014年11月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Women age > 18
- •2. Histologically or cytologically confirmed advanced (FIGO stage IVB), or recurrent/persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix will be eligible.
- •3. No prior chemotherapy for recurrent cervical cancer.
- •?Prior concomitant cisplatinum chemotherapy during radiotherapy is allowed (except if recurrence is within 6 months after the end of the platinum containing chemotherapy).
- •?Cases primarily treated with neoadjuvant chemotherapy before radical local surgery are eligible at the time of first recurrence. (except if recurrence is within 6 months after the end of the platinum containing chemotherapy).
- •?Cases primarily treated with neoadjuvant chemotherapy before radical local surgery followed by adjuvant radiochemotherapy are eligible at the time of first recurrence (except if recurrence is within 6 months after the end of the platinum containing chemotherapy).
- •?Cases primarily treated with neoadjuvant chemotherapy before radical local surgery followed by adjuvant radiotherapy are eligible at the time of first recurrence (except if recurrence is within 6 months after the end of the platinum containing chemotherapy).
- •4. Life expectancy at least (3 months)
- •5. ECOG performance status score of 0 or 1
- •6. At least one measurable lesion according to RECIST 1.1 criteria.
- •7. Signed and dated written informed consent prior to admission to the study in accordance with ICH-GCP guidelines and to the local legislation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •8. Prior chemotherapy except platin-based concomitant chemotherapy during radiotherapy
- •9. Prior treatment with nintedanib or any other VEGFR inhibitor
- •10. Known hypersensitivity to the trial drugs or to their excipients
- •11. Brain or leptomeningeal metastases
- •12. Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels
- •13. Tumor infiltrating the mucosa of the bowel or bladder, or known fistulas between the tumor and the gastrointestinal or urinary tract.
- •14. Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial
- •15. Therapeutic anticoagulation is not allowed, unless the patient is on stable anti-coagulation.
- •16. Major injuries within the past 10 days prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
- •17. History of clinically significant haemorrhagic or thromboembolic event in the past 6 months
- •18. Known inheritated predisposition to bleeding or thrombosis
- •19. Significant cardiovascular diseases ( i.e. uncontrolled hypertension, unstable angina within the past 6 months, history of infarction within the past 6 months prior to start of study treatment, congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion)
- •20. History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months.
- •21. Abnormal renal, liver or bone marrow function defined as:
- •? Proteinuria CTCAE grade 2 or greater
- •? Creatinin > 2 ULN or GFR < 30 ml/min
- •? Hepatic function: total bilirubin outside of normal limits; ALT or AST > 1.5 ULN in pts without liver metastasis. For Pts with liver metastases: total bilirubin outside of normal limits, ALT or AST > 2.5 ULN
- •? Coagulation parameters: International normalised ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN
- •? Absolute neutrophil count ( ANC) < 1500/µl, platelets < 100000/µl, Haemoglobin < 9.0 g/dl
- •22. Other malignancies within the past 3 years or other malignancy with recurrence the past 3 years or with high risk of recurrence in the first year. In exception to this rule, the following malignancies may be included: non-melanomatous skin cancer (if adequately treated) , any premalignant (e.g. in situ) carcinoma, or basocellular carcinoma.
- •23. Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
- •24. Active or chronic hepatitis C and/or B infection or known HIV infection
- •25. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
- •26. Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study.
- •27. Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females,) during the trial and for at least three months after end of active therapy
- •28. Pregnancy or breast feed
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