Normothermic intraperitoneal chemotherapy (NIPEC) with carboplatin following cytoreductive surgery in elderly and fragile ovarian cancer patients: a feasibility study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety of the treatment of cytoreductive surgery combined with Normothermic Intraperitoneal Chemotherapy with carboplatin: The proportions of patients 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.
研究概览
简要总结
This study aims to assess Normothermic Intraperitoneal Chemotherapy’s (NIPEC) safety, feasibility, pharmacokinetics, and its impact on local tissue inflammation and ischemia. NIPEC could offer an alternative treatment for elderly ovarian cancer patients ineligible for Hyperthermic Intraperitoneal Chemotherapy (HIPEC).
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 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.
- •Completeness of cytoreduction to less than 2.5 mm.
- •Demographically belonging to Region of Southern Denmark.
排除标准
- •Progression of disease during neoadjuvant chemotherapy.
- •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 receiving carboplatin, such as drug allergy. The medical oncologist makes the decision.
结局指标
主要结局
Safety of the treatment of cytoreductive surgery combined with Normothermic Intraperitoneal Chemotherapy with carboplatin: The proportions of patients 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.
Safety of the treatment of cytoreductive surgery combined with Normothermic Intraperitoneal Chemotherapy with carboplatin: The proportions of patients 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.
- Proportion of reoperations and cause.
- Proportion of readmissions and cause.
- Time from surgery to the first dose of adjuvant systemic chemotherapy.
- Proportion of participants completing the adjuvant chemotherapy of three cycles.
- Feasibility according to patients willing to participate in the trial.
- PROs on QoL assessed by questionnaires.
- Costs of NIPEC in addition to standard treatment.
- Carboplatin local peritoneal tissue and systemic plasma pharmacokinetics measured using microdialysis.
- Local peritoneal tissue and systemic response using inflammation protein markers, ischemic metabolites and histology. The local response will be assessed in both macroscopic healthy peritoneal tissue and tumour nodules less than 1 cm.
研究者
Lone Kjeld Petersen
Scientific
Odense University Hospital