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临床试验/NCT01539785
NCT01539785Unknown不适用

Surgery Plus Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) Versus Surgery Alone in Patients With Platinum-sensitive First Recurrence of Ovarian Cancer: a Prospective Randomized Multicenter Trial.

Catholic University of the Sacred Heart2 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
158
试验地点
2
主要终点
Estimate of progression free interval (PFI) in the two trial arms.

研究概览

简要总结

The purpose of this study is to determine the role of surgery followed by hyperthermic intra-peritoneal chemotherapy (HIPEC) versus surgery alone in patients with platinum-sensitive first recurrence of ovarian cancer. Moreover it is a prospective randomized multicenter trial, aimed to investigate the prognostic role of surgery plus HIPEC versus surgery alone in terms of progression free interval, overall survival, morbidity and mortality, second recurrence pattern, quality of life with EORTC QLQ-C30 and QLQ OV28 questionnaires.

详细描述

Among the malignancies of the female genital tract, ovarian cancer is the second most common cancer after the endometrial tumor, but the more lethal, representing the fifth leading cause of death among women in industrialized countries. For the most part, these are epithelial tumors (>70%), who begin with vague gastrointestinal symptoms, general malaise, abdominal bloating, weight loss and fatigue. Because of the non-specificity oh the symptoms and the often late presentation, about 70% of the diagnosis is made at an advanced stage of disease (IIIC). In the last two decades only a modest improvement in survival was achieved. Moreover, even after optimal cytoreduction followed by adjuvant chemotherapy based on platinum and taxane, which is currently the standard for this type of disease, most patients with stage III disease developed a recurrence.

Rational of HIPEC in recurrent ovarian cancer: the cytoreduction. Contrary to what happens in the primary disease is not yet clear what is the standard treatment in recurrent epithelial ovarian cancer (EOC).

Patients who experience a recurrence within 6 months from the end of the first-line chemotherapy are considered platinum-resistant and have applied for a salvage treatment with second line drugs with low response rates and poor survival. Patients who recur after 6 months are considered platinum-sensitive and, therefore, subject to a new chemotherapy treatment with a platinum compound possibly in combination with paclitaxel (re-challenge). In these patients it is possible to achieve a clinical response rate similar to the primary treatment, with median survival reported between 12 and 24 months. Recently surgery affirmed a major role not only in the primary treatment but also in recurrent chemo-sensitive ovarian cancer. A meta-analysis of 2019 patients has shown that obtain an optimal secondary cytoreduction independently correlates with survival (OS) after recurrence. However, a recent Cochrane, showed that, from the studies available nowadays, is not possible to substantiate a difference in prognosis between the exclusive chemotherapy treatment and the association of surgery with adjuvant chemotherapy.

The results of the multicenter trial DESKTOP I show that, even in the presence of peritoneal carcinomatosis, the 2-year survival improves if an optimal cytoreduction is obtained.

Rational of HIPEC in recurrent ovarian cancer: intraperitoneal chemotherapy Many patients who undergo optimal cytoreduction may benefit from adjuvant chemotherapy administered intraperitoneally (IP). Several randomized trials have demonstrated improved survival associated with IP platinum-based chemotherapy as first-line adjuvant therapy after optimal cytoreduction, although it is still unclear which patients might benefit most, or what would be the best drug , its dose or the right number of cycles. The adjuvant IP therapy, however, seems to have more side effects than intravenous therapy (IV) and consequently a worsening of the quality of life (QOL).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age over 18 and under 70 years
  • Patients affected by a first recurrence of ovarian cancer with measurable lesions or not, but evaluable (upwards of Ca125 for 2 consecutive assessments).
  • ECOG-performance status ≤ 2
  • Ovarian cancer limited to the abdominal cavity with or without extraperitoneal spread considered resectable at intraoperative evaluation
  • Evidence of tumor recurrence diagnosed after 6 months from primary treatment
  • Previous-based chemotherapy of carboplatin and taxanes
  • Positive Peritoneal Washing in the presence of other abdominal disease surgically resectable
  • Adequate respiratory, hepatic, cardiac, kidney and bone marrow function (absolute neutrophil count > 1500/mm3, platelets > 150,000/μl, creatinine clearance > 60 mL/min according to Cockroft formula)
  • Patient-compliant and psychologically able to follow the trial procedures

排除标准

  • Non-epithelial ovarian cancer or borderline ovarian tumor
  • Pregnancy or breastfeeding
  • Patients affected by major depressive disorder even in treatment or minor mood disorders
  • Patients with severe impairment of respiratory, hepatic or renal function
  • Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease
  • Patients with active infection or other neoplastic disease in progress
  • Patients with bowel obstruction
  • Inadequate bone marrow, liver, kidney function
  • No clear-peritoneal disease at surgical exploration
  • Patients with ascites > 500 ml (the TAC)
  • Patients on maintenance therapy with Antiangiogenic drugs
  • Patients with secondary or tertiary recurrence, or already submitted to HIPEC
  • Patients who have already made the second or third line chemotherapy.

结局指标

主要结局

Estimate of progression free interval (PFI) in the two trial arms.

时间窗: 36 months

The progression-free interval (PFI) will be evaluated from the time of secondary cytoreduction (± HIPEC) to the evidence of a second recurrence of disease.

次要结局

  • Evaluation of the morbidity and mortality in the two trial arms.(36 months)
  • Estimate of overall survival (OS)in the two trial arms.(36 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Giovanni Scambia

Direttore del Dipartimento per la Tutela della salute della Donna e della Vita Nascente Università Cattolica del Sacro Cuore-Roma

Catholic University of the Sacred Heart

研究点 (2)

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