Normothermic intraperitoneal intraoperative chemotherapy following Interval Cytoreductive Surgery in Advanced CA Ovary (Stage IIIC) - A randomised controlled study (NICOR trial)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- 1) Progression-free Survival (PFS) [Time frame: from randomization to first progression, relapse or death from any cause, whichever came first, assessed up to 2 years. (Follow-up up to 5 years)]
研究概览
简要总结
Advanced epithelial ovarian cancer has a poor prognosis. Surgery after a few courses of chemotherapy or primary surgery followed by chemotherapy is the standard of care for these patients. However, despite good response after surgery and chemotherapy disease returns in most patients within 1-2 years. This signifies the inherent unfavourable nature of the advanced disease. Various studies were done with the aim of improving the survival of such patients. One of the approach is to directly instill chemotherapy into the abdomen during surgery which is called intraperitoneal chemotherapy. In addition, early postoperative intraperitoneal chemotherapy also known as EPIC has certain conceptual benefits, as it is applied shortly after cytoreductive surgery when the tumour burden is minimal, uneven drug distribution is reduced as the adhesions are not formed and there prevention of entrapment of residual cancer cells in postoperative fibrin deposits. Traditionally EPIC is administered in the postoperative period, usually between days 1 to 5, through both an inflow and outflow drains inserted during surgery. We will be giving chemotherapy inside the abdomen immediately after completion of surgery and will be kept for 24 hours. After 24 hours excess fluid will be removed by the intraabdominal drains.
Methodology (procedure):
Patients with advanced Ca Ovary stage IIIC will be included in the study. Informed consent will be taken from every patient. After adequate surgery cisplatin chemotherapy will be instilled intraperitoneal chemotherapy with the help of intraabdominal drains placed inside the abdomen. Drains will be unclamped later for any unabsorbed fluid to be removed. Preloading with potassium chloride and magnesium sulphate will be given to avoid side effects. Adequate fluid hydration will be maintained. Antiemetics( to prevent vomiting) will be provided for control of emesis associated with cisplatin. Monitoring and correction of dyselectrolytemia will be done. Monitoring of adverse effects will be done and recorded as per existing guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •20 years to 70 years.
- •Histologically proven primary epithelial ovarian carcinoma or fallopian tube carcinoma or peritoneal carcinoma (including serous papillary adenocarcinoma, clear-cell carcinoma, mucinous adenocarcinoma and endometrioid carcinoma).
- •Pre-therapy FIGO (International Federation of Gynaecology and Obstetrics) stage IIIC (clinical).
- •Patient eligible for Interval Cytoreductive Surgery (ICS) after neo-adjuvant chemotherapy.
- •In case of neo-adjuvant chemotherapy, surgery should be performed in a time interval of 3 to 5 weeks.
- •WHO (World Health Organization) performance status less than
- •Adequate bone marrow and renal function, as evidenced by the following tests performed within 7 days prior to surgery.
- •Absence of contraindication to receive the products used in this study (cisplatin and products used in neo-adjuvant/ adjuvant chemotherapy) according to the most recent SmPC (Summary of Product Characteristics) of these products.
- •Patient is willing to participate and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up.
- •Signed written informed consent.
- •Residual disease after surgery (cytoreduction score CC) CC 0 (no macroscopic residue) or CC 1 11) Per-operative haemorrhage less than2 L 12) Diuresis maintained during surgery, without oliguria or anuria .
排除标准
- •Benign disease, borderline disease, non-epithelial ovarian carcinoma or carcinosarcoma.
- •Decompensated liver disease.
- •Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
- •Auditory impairment 5) Disease that contraindicates hyper hydration (including cardio-respiratory disease).
- •Other uncontrolled intercurrent disease including, but not limited to: diabetes; hypertension; symptomatic congestive heart or pulmonary failure; renal, hepatic or severe gastrointestinal (associated with diarrhoea) chronic disease.
- •Any unresolved NCI-CTCAE grade ≥ 2 toxicity from previous anticancer therapy (excluding alopecia).
- •Concomitant treatment with prophylactic phenytoin.
- •Bowel resection anastomosis.
- •Receipt of live attenuated vaccine, within 30 days prior to inclusion (and, if patient is enrolled, up to 30 days after the last administration of study treatment).
- •Pregnant or breast feeding woman.
- •Psychiatric illness or social situation that would limit compliance with study requirement, substantially increase the risk of side effects, or compromise the ability of the patient to give written informed consent.
- •Person under guardianship.
结局指标
主要结局
1) Progression-free Survival (PFS) [Time frame: from randomization to first progression, relapse or death from any cause, whichever came first, assessed up to 2 years. (Follow-up up to 5 years)]
时间窗: 1) Progression-free Survival (PFS) will be assessed at baseline, 1 year and 2 year
次要结局
- Overall survival [Time Frame: From date of randomization to the date of death or date of last follow up].(2 years follow up will be done for OS)
研究者
Upasana Baruah
Dr B Borooah Cancer Institute