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临床试验/CTRI/2025/07/090264
CTRI/2025/07/090264尚未招募2/3 期

Comparative analysis of peritonectomy techniques in detection of occult peritoneal disease in Interval cytoreductive surgery for advanced ovarian cancer (ToPIC)-An Exploratory randomised study

All India institute of medical sciences Rishikesh1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年7月21日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
20
试验地点
1
主要终点
Percentage prevalence of occult tumour in peritoneal specimens

研究概览

简要总结

This is an Exploratory randomised control trial. aimed at comparing the different peritonectomy techniques in detection of occult peritoneal disease in Interval cytoredcutive surgery for advanced ovarian cancer

Background-The goal of iCRS is to obtain a complete gross resection or complete cytoreduction (CC-0 resection) which is achieved by resecting sites of visible residual disease. This includes total hysterectomy with bilateral salpingo oophorectomy, pelvic and/or para aortic lymphadenectomy, supracolic omentectomy, peritoneal resection and visceral resections wherever necessary. In advanced ovarian cancer, after first line treatment, approximately 10% of the patients will never develop a recurrence. For the remaining 90%, the disease will invariably recur, with the peritoneum being the only or one of the sites of recurrence in more than 80% of the patients.In stages III-C and IV, the diaphragmatic peritoneum is invariably involved. It has been shown that despite having a normal appearance after NACT, microscopic residual disease is present in 15%–35% of the patients

Purpose-The present study aims to analyse the role of extent of parietal peritonectomy on detection of  occult peritoneal metastatic disease, morbidity and rate of recurrence in women undergoing interval cytoreductive surgery for advanced epithelial ovarian cancers The rationale behind the study is to detect presence of occult disease in normal looking peritoneum so that adjuvant treatment can be planned accordingly. Also the percentage of occult disease detection will be compared in the arms i.e total vs involved field parietal peritonectomy versus multiple peritoneal biopsies in order to counterweigh occult disease detection versus increased surgical morbidity.

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
18.00 Year(s) 至 75.00 Year(s)(—)
性别
Female

入选标准

  • Histologically proven epithelial ovarian cancer
  • undergoing interval cytoreduction surgery
  • post platinum based neoadjuvant chemotherapy.

排除标准

  • Women with non epithelial ovarian cancer
  • Women with visible peritoneal disease
  • Patients with progressive disease after neoadjuvant chemotherapy
  • Patients undergoing primary cytoreductive surgery
  • Patients with poor performance status, ECOG more than 3 6.Patients not consenting for the trial.

结局指标

主要结局

Percentage prevalence of occult tumour in peritoneal specimens

时间窗: At baseline Immediately post operative period

次要结局

  • 1. Intraoperative adverse events graded according to Common terminology criteria for adverse events CTCAE 5.0 (Annexure 7).(2. Postoperative adverse events (within 30 days) according to Clavien Dindo classification (Annexure 8).)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr. Amrita Gaurav

All India institute of medical sciences, Rishikesh

研究点 (1)

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