EUCTR2018-003756-20-SE进行中（未招募）1 期
A randomized double-blind placebo-controlled phase II trial of Rucaparib maintenance therapy for patients with locally advanced cervical cancer - ENGOT-Cx7-NSGO/MaRuC
ordic Society of Gynaecological Oncology-Clinical Trial Unit0 个研究点目标入组 162 人开始时间: 2019年8月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 162
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
入选标准
- •1. Histologically confirmed squamous cell, adenocarcinoma or adenosquamous carcinoma of the cervix.
- •2. Patient must have completed definitive chemoradiation and is evaluated to be in complete remission 10-12 week’s post definitive treatment.
- •3. Initial FIGO stage IIIA, IIIB, IIIC, IVA (histological verification) according to the FIGO classification 2018.
- •4. Toxicities resulting from definitive treatment must resolve to grade =1 prior to randomization.
- •5. Patient agrees to undergo all analysis; radiological examinations according to protocol.
- •6. The patient agrees to complete PROs (QoL questionnaire) during study treatment.
- •7. Patients must give informed consent.
- •8. Patients must be at least 18 years of age.
- •9. ECOG performance status 0-1
- •10. Serum albumin >30g/l.
- •11. Adequate organ function
- •Absolute neutrophil count (ANC) =1,500/mcL
- •Platelets >100,000/mcL
- •Haemoglobin = 9g/dl (no blood transfusions for 4 weeks prior entering the trial.)
- •Serum creatinine =1.5x upper limit of normal (ULN) or calculated creatinine clearance =50mL/min using Cockcroft-Gault formula.
- •Total bilirubin =1.5x ULN.
- •Alanine aminotransferase (ALT) =2.5x ULN
- •12. Life expectancy of at least 12 weeks.
- •13. Women of childbearing potential must use highly effective methods of birth control for the duration of study participation and for 6 months afterwards.
- •14. All patients: Patients should not donate blood or blood components while participating in this study and through 90 days after receipt of the final dose of IMP.
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 52
排除标准
- •1.Histological types other than in inclusion criteria, like sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial cancers.
- •2. Concurrent cancer therapies or cancer therapy (chemotherapy, radiotherapy, surgery, immunotherapy, biologic or hormonal therapy) within last 4 weeks.
- •3. Concurrent treatment with an investigational agent or participation in another clinical trial.
- •4. Previous malignant disease: patients are not eligible for the study if actively being treated of invasive cancer. Patients with previous malignant disease who are relapse-free and treatment-free for more than three years may enter this study. Patients with previous history of in-situ carcinoma of cervix, or non-invasive basal cell and squamous cell skin carcinoma can enter this trial.
- •5. Active infections or other serious underlying significant medical illness, abnormal laboratory finding or psychiatric illness/social situation that would, in the investigator’s judgment, make the patient inappropriate for this study. Known active or chronic hepatitis C and/or B infection. Has known history of tuberculosis.
- •6. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug.
- •7. Any evidence of distant metastases.
- •8. Significant cardiovascular diseases, including uncontrolled hypertension, clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within 6 months prior to randomization, congestive heart failure >NYHA II (New York Heart Association), severe peripheral vascular disease, clinically significant pericardial effusion.
- •9. Pregnancy or breastfeeding. Patients with preserved reproductive capacity, unwilling to use a medically acceptable method of contraception for the duration of the trial and for 6 months afterwards.
- •10. Known hypersensitivity to the trial drugs, or to their excipients.
- •11. Persons who cannot comply to the protocol or at the discretion of the investigator is unsuitable.
- •12. Patients with dependency on the sponsor, investigator or study site.
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