Normothermic Intraperitoneal Chemotherapy (NIPEC) With Carboplatin Following Cytoreductive Surgery in Elderly and Frail Ovarian Cancer Patients: a Feasibility Study.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion of Participants with Treatment-Related Adverse Events and Adverse Reactions
研究概览
简要总结
The purpose of this feasibility study is to investigate whether NIPEC with carboplatin after surgery is safe for the elderly and frail women with advanced ovarian cancer.
To achieve this, women with advanced ovarian cancer who receive surgery followed by NIPEC will be closely monitored in the period after treatment. We will assess complications, side effects, recovery after surgery and NIPEC, and whether standard chemotherapy can be started on time and completed as planned.
In addition, participants will be followed for six months using questionnaires and interviews to evaluate patient-reported outcomes, including quality of life.
In the more technical assessment of NIPEC, carboplatin tissue pharmacokinetics and inflammatory responses during and after NIPEC will be analysed using microdialysis and histology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Patient capability of giving informed consent.
- •Age ≥ 70 years.
- •Women diagnosed with epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer FIGO stage III-IV with planned interval cytoreductive surgery. Stage IV patients will only be included if they have resectable metastases within the abdominal cavity and/or abdominal wall or if they have complete remission of extra-abdominal metastases after three series of neoadjuvant chemotherapy.
- •Performance status 1-
- •American Society of Anaesthesiologists (ASA) scores I-III.
- •Normal preoperative kidney, liver and bone marrow function (according to the CTCAE v.5.0): Normal kidney function definition: eGFR or GFR ≥ 60 ml/min. Normal liver function: ALAT and/OR ASAT ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 ×ULN. Normal bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 75 × 10⁹/L; Haemoglobin level ≥ 6 mmol/L;
- •Completeness of cytoreduction to less than 2.5 mm.
- •Demographically belonging to Region of Southern Denmark.
排除标准
- •Progression of disease during NACT.
- •Intrabdominal metastases not resectable upon NACT.
- •Former history of breast cancer or other malignancies within 5 years before inclusion, except from non-melanomatous skin cancer.
- •Contradictions to receive carboplatin according to the SmPC (the medical oncologist makes the decision): Drug allergy (active drug or components); Severe myelosuppression; Severe kidney deficiency (creatinin clearance ≤ 30 ml/min); Bleeding tumours; Concurrent usage of vaccination against yellow fever; Severe allergic reaction to other platinum compounds in the medical history.
结局指标
主要结局
Proportion of Participants with Treatment-Related Adverse Events and Adverse Reactions
时间窗: The day that adjuvant chemotherapy starts (up to 4-6 weeks).
The proportions of participants experiencing perioperative and postoperative complications of adverse events (AEs) of grade 3 to 5 according to the Common Terminology for Adverse Events (CTCAE) version 5.0 and Clavien-Dindo classification (surgical AEs) together with adverse drug reactions (ADRs) related to carboplatin until the day of adjuvant chemotherapy start.
次要结局
- Length of hospital stay(The day of hospital discharge (up to 14 days).)
- Proportion of reoperations(The day that adjuvant chemotherapy starts (up to 4-6 weeks).)
- Proportion of readmissions.(The day that adjuvant chemotherapy starts (up to 4-6 weeks).)
- Time from surgery to the first dose of adjuvant systemic chemotherapy.(The day that adjuvant chemotherapy starts (up to 4-6 weeks).)
- Completion of adjuvant chemotherapy.(At second follow up (3 months).)
- Patients' willingness to participate.(At study completion (at 6 months))
- Patient reported adverse events(At first follow up (up to 6 weeks).)
- Change in health-related quality of life using EORCT-questionnaires(Baseline, follow-up 1 (up to 6 weeks), follow-up 2 (3 months) and follow-up 3 (6 months).)
- Carboplatin AUC in peritoneum parietale(30, 60, 90, 120, 150, 180, 210, 240, 300, 360 min. post-dose)
- Carboplatin Cmax in peritoneum parietale(Up to 360 min. post-dose)
- Carboplatin Tmax in peritoneum parietale(Up to 360 min. post-dose)
- Carboplatin T½ in peritoneum parietale(Up to 360 min. post-dose)
- Carboplatin AUC in tumor tissue(30, 60, 90, 120, 150, 180, 210, 240, 300, 360 min. post-dose)
- Carboplatin Cmax in tumor tissue(Up to 360 min. post-dose)
- Carboplatin Tmax in tumor tissue(Up to 360 min. post-dose)
- Carboplatin T½ in tumor tissue(Up to 360 min. post-dose)
- Change in inflammatory response in parietal peritoneum(Baseline (before NIPEC) and up to 15 min. post-NIPEC)
- Change in inflammatory response in tumor tissue(Baseline (before NIPEC) and up to 15 min. post-NIPEC)
- Inflammatory protein changes in parietal peritoneum(90 min and 360 min after NIPEC initiation (post-dose).)
- Ichemic metabolites changes in parietal peritoneum(30, 60, 90, 120, 150, 180, 210, 240, 300, 360 min. after NIPEC initiation (post-dose).)