NL-OMON39751招募中不适用
Olaparib dose escalating trial in patients treated with radiotherapy with of without daily dose Cisplatin for locally advanced non-small cell lung carcinoma. - Olaparib with CCRT or with RT in locally advanced NSCLC
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 72 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
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
- 18 至 99（—）
入选标准
- •1. >=18 years of age
- •2. Histologically or cytologically confirmed diagnosis of NSCLC
- •3. For chemoradiotherapy patients only: stage II/III non-operable disease, without malignant pleural effusion
- •4. For (sequential chemo-)radiotherapy patients only: indication for radical locoregional radiotherapie
- •5. Acceptable pulmonary function as defined by a Fev1 of >=30% and a DLCO of >= 40% of predicted,
- •6. NYHA I-II functional status
- •7. Expected risk of radiation-induced pulmonary toxicity is modest: MLD <= 20 and maximum cord dose 50 Gy
- •8. WHO performance 0-1
- •9. Life expectancy of at least 6 months
- •10. Adequate hematological, renal and hepatic functions
- •a. Hemoglobin >= 6.2 mmol/l
- •b. Leucocytes > 3.0 x 109/l
- •c. Absolute neutrophil count > 1.5x109/l
- •d. Platelet count > 100 x 109/l
- •e. Total bilirubin < 1.5 x UNL
- •f. ASAT/ALAT < 2.5 x UNL
- •g. Alkaline phosphatase < 5 x UNL
- •h. Creatinine clearance >= 70 ml/min; creatinine clearance >= 50 ml/min in patients not receiving concurrent cisplatin; measured using a 24-hours urine sample or calculated using the Cockcroft-Gault formula
- •i. Urine dipstick for proteinuria < 2+. If urine dipstick is >= 2, 24 hour urine must demonstrate < 500 mg of protein in 24 hours
- •11. No pre-existing sensory neurotoxicity grade >= 2 (CTCAE)
- •12. Patients of reproductive potential must agree to practice two effective medically approved contraceptive method during the trial and 3 months afterwards
- •13. Signed written informed consent.
排除标准
- •1. Concurrent active malignancy other than localized, non-melanoma skin cancer or carcinoma-in-situ of the cervix (unless definitive treatment was completed 1 year or more before study entry and the patient has remained disease free)
- •2. Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 3 weeks prior to start of therapy (or a longer period depending on the defined characteristics of the agents used e.g. 6 weeks for mitomycin or nitrosourea). Patients may continue the use of LHRH agonists for cancer; bisphosphonates for bone disease and corticosteroids.
- •3. Patients, selected for sequential chemoradiotherapy, are excluded if no disease control (all responses except progression) is obtained after induction chemotherapy.
- •o Ipsilateral radiotherapy to the chest;
- •o Chemotherapy within the last year
- •5. History of interstitial pneumonitis (to include diffuse alveolar damage, non-malignant causes of pneumonitis, ARDS, alveolitis, cryptogenic organising pneumonia, obliterative bronchiolitis, non-malignant causes of pulmonary fibrosis, eligibility based on the judgement of the primary investigator), active infection on day of enrollment
- •6. Significant cardiovascular disease as defined by:
- •o History of congestive heart failure requiring therapy;
- •o History of unstable angina pectoris or myocardial infarction up to 6 months prior to trial entry;
- •o Presence of severe valvular heart disease;
- •o Presence of a ventricular arrhythmia requiring treatment;
- •o Uncontrolled hypertension
- •7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
- •8. Participation in other trial with investigational drug or treatment modality
- •9. Co-existing serious active infection requiring parenteral antibiotics
- •10. Patients with hepatic disease e.g. patients with known serologically positive Hepatitis B or Hepatitis C as they may be more at risk of toxicity from Olaparib
- •11. Immunocompromised patients e.g. human immunodeficiency virus (HIV)
- •12. Myelodysplastic syndrome/acute myeloid leukaemia or features suggestive of MDS/AML on peripheral blood smear
- •13. Any co-existing medical condition that in the investigator*s judgement will substantially increase the risk associated with the patient*s participation in the study
- •14. Gastrointestinal disorders that may interfere with absorption of the study drug or patients who are not able to take oral medication
- •15. Concomitant medications:
- •a. Any previous treatment with a PARP inhibitor, including Olaparib
- •b. Patients receiving the following classes of inhibitors of CYP3A4 (see Section 7.4 for guidelines and wash out periods)
- •- Azole antifungals
- •- Macrolide antibiotics
- •- Protease inhibitors
- •16. Persistent grade 2 or greater toxicities, from any cause
- •17. Pregnant or breast-feeding women
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