HIPEC with Surgery for Ovarian Cancer (OVHIPEC-2 Trial)
Palo Alto (17 mi)Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: The Netherlands Cancer Institute
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial tests if combining surgery with heated chemotherapy improves outcomes for patients with stage III ovarian cancer compared to surgery alone. Heated chemotherapy has shown improved disease-free and overall survival in patients with stage III ovarian cancer when combined with surgery to remove as much of the tumor as possible.
What safety data exists for HIPEC with surgery for ovarian cancer?The safety data for HIPEC with surgery for ovarian cancer includes information on the side effects and risks associated with cisplatin, a key component of the treatment. Common side effects of cisplatin include vomiting, nausea, and alopecia. Toxicity primarily affects the digestive and renal systems, necessitating hospitalization for administration. In a study involving cytoreductive surgery with cisplatin-based chemotherapy, postoperative renal insufficiency occurred in 12% of patients, with 1.4% requiring temporary dialysis. High-dose cisplatin increased the risk of renal insufficiency. Neurologic effects and anemia were also noted as major toxic effects, but these were reversible after treatment cessation. Overall, the risk of postoperative renal failure was considered within an acceptable range.134514
Is the treatment of HIPEC with Surgery and the drug Cisplatin promising for ovarian cancer?Yes, the combination of HIPEC with Surgery and the drug Cisplatin is promising for treating ovarian cancer. Studies show that this approach can lead to favorable outcomes, such as longer survival times and better disease control.910111213
What data supports the idea that HIPEC with Surgery for Ovarian Cancer is an effective treatment?The available research shows that combining surgery with HIPEC, which involves heating chemotherapy drugs and applying them directly inside the abdomen, has shown positive results for treating advanced ovarian cancer. One study highlights that this combination treatment has favorable outcomes for patients with advanced epithelial ovarian cancer. Additionally, using cisplatin, a key drug in HIPEC, has been found to be very useful in treating advanced stages of ovarian cancer, improving survival rates when used after surgery to remove as much of the cancer as possible. This suggests that HIPEC with surgery can be an effective treatment option for ovarian cancer.267811
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for individuals with stage III epithelial ovarian, fallopian tube, or primary peritoneal cancer who are candidates for initial surgery to remove the tumor. They must not have had any other cancers in the past 5 years and should not have received prior treatment for their current cancer.Inclusion Criteria
My cancer is in stage III and started in the ovary, fallopian tube, or nearby areas.
Exclusion Criteria
My cancer is at the most advanced stage (stage IV).
I have received treatment for my current cancer.
It's not possible to remove all of my cancer with surgery.
Treatment Details
The study is testing whether adding hyperthermic intraperitoneal chemotherapy (HIPEC), which involves heating chemotherapy drugs and delivering them directly into the abdominal cavity, improves outcomes when combined with standard surgery compared to surgery alone.
2Treatment groups
Experimental Treatment
Active Control
Group I: HIPECExperimental Treatment1 Intervention
Primary cytoreductive surgery with HIPEC with cisplatin
Group II: conventional surgeryActive Control1 Intervention
Primary cytoreductive surgery without HIPEC
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
🇺🇸 Approved in United States as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
🇨🇦 Approved in Canada as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
🇯🇵 Approved in Japan as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a clinic near you
Research locations nearbySelect from list below to view details:
City of HopeDuarte, CA
MSKCC New YorkNew York, NY
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Who is running the clinical trial?
The Netherlands Cancer InstituteLead Sponsor
References
Cancer of the ovary: a summary of experience with cis-dichlorodiammineplatinum(II) at the Royal Marsden Hospital. [2013]A review of the use of cis-dichlorodiammineplatinum(II) (cis-platinum) as a single agent in 82 patients with advanced ovarian carcinoma, previously treated with chemotherapy, shows that response rates of 33% and 52% are achieved with doses of 30 and 100 mg/m2 respectively. In 58 previously untreated patients a combination of chlorambucil and cis-platinum (regimen B) was compared in a randomized study with a combination of chlorambucil, cis-platinum, and Adriamycin (regimen C). Complete responses were seen in 32% and 41% of the patients respectively. Remissions were most prolonged in patients with complete regressions, the median being greater than 15 months for both regimens. Because of the good regressions, second-look operations have been possible in 12 patients for the purpose of confirming regression and performing radical surgical removal. In six of these patients, all specimens failed to show evidence of residual carcinoma. The major toxic effects of cis-platinum in our hands are neurologic effects and anemia; both have been reversible after cessation of treatment.
[The value of cis-diamminedichloroplatinum (cis-platinum) CDDP in the treatment of stage III and IV cancers of the ovary (author's transl)]. [2013]Cis-diamminedichloroplatinum is remarkably useful in stage III and IV cancers of the ovary. It should therefore be added to the armamentarium of chemotherapeutic substances used up till now. This effectiveness adds extra indication to the use of chemotherapy as a first treatment for stage III cancers of the ovary after the lesions have been reduced as far as possible by surgery.
[Effectiveness of cisplatin alone and in combination within the scope of primary therapy of ovarian cancer. Results of a prospective multicenter study]. [2013]The efficiency of cis Platin (DDP) alone and in combination with Adriamycine (ADM) and Cyclophosphamid (CTX) were evaluated in a prospective randomized trial containing 173 pat. suffering from advanced ovarian cancer (FIGO III/IV). Therapeutic schedule and results: (table; see text) The most side effects concerned vomiting (WHO Grad 2) in 90%, nausea (WHO Grad 2) in 95% and alopecia in 50% out of all pat.
[Antitumor activity of platinum analogs against human ovarian tumors heterotransplanted into nude mice]. [2013]The chemotherapeutic effects of CDDP, CBDCA and CHIP on human ovarian cancers heterotransplanted into nude mice (mucinous cystadenocarcinoma OVA-1, poorly differentiated adenocarcinoma OVA-2, endometrioid adenocarcinoma OVA-3, serous cystadenocarcinoma OVA-4, and three yolk sac tumors YST-1, YST-2, YST-3) were examined. OVA-1 did not respond to CDDP, although it responded well to CBDCA and CHIP. OVA-2 responded well to all these platinum analogs. OVA-3 responded well to CDDP, but did not respond to CBDCA or CHIP. OVA-4 responded well to CDDP and CBDCA, but did not respond to CHIP. Tumors YST-2 and YST-3 exhibited broadly comparable sensitivity to CDDP and the two other analogs, and YST-1 was substantially more sensitive to CDDP than to CBDCA or CHIP. The results indicated the necessity of selection of platinum analogs according to the histological types of tumor for the effective treatment of ovarian cancer.
Cisplatinumdiamminodichloride (CPDD) in chemotherapy of cancers: a phase II therapeutic trial. [2019]We have conducted a phase II trial of cisplatinumdiamminodichloride (CPDD) which not only demonstrated its remarkable activity in embryonic carcinoma of the testes, but also in ovarian carcinoma, in melanoma, and in epidermoid carcinoma, especially of the head and of the uterus cervix. Its toxicity, manifested mainly in the digestive and renal tracts, confines its administration to hospitalized patients only. This compound is now indicated in combination therapy for the above-mentioned tumors.
Surgically documented responses to paclitaxel and cisplatin in patients with primary peritoneal carcinoma. [2019]Intra-abdominal carcinomatosis indistinguishable from ovarian cancer may occur after removal of the ovaries or in association with surface ovarian involvement. Because its histologic pattern and behavior approximate those of ovarian cancer, this entity, known as primary peritoneal carcinoma, has been treated in a similar fashion--cytoreductive surgery followed by systemic chemotherapy. This review was undertaken to assess the efficacy of combination chemotherapy with paclitaxel and cisplatin, the current front-line chemotherapeutic regimen for ovarian cancer, in patients with primary peritoneal carcinoma. Sixteen patients diagnosed between January 1989 and July 1994 with primary peritoneal carcinoma were treated at the Hospital of the University of Pennsylvania. The records of the three patients whose initial chemotherapeutic regimen included paclitaxel and cisplatin were reviewed. An additional case from the Robert Wood Johnson Medical Center, Camden, New Jersey, was included. Pathologic review of all cases was conducted at the time of clinical management and again as part of this study. Reassessment laparotomy was performed in all patients after the completion of chemotherapy. Complete clinical information was available on all patients. All four patients presented with intra-abdominal carcinomatosis, and large volume (> 1 cm) residual disease was present following initial cytoreduction. Following chemotherapy, second-look laparotomy documented one complete pathologic response and three partial (>50% tumor volume reduction), but marked, responses. Combination chemotherapy with paclitaxel and cisplatin produces surgically documented responses in patients with primary peritoneal carcinoma.
[Steps in the treatment of ovarian cancer]. [2017]The paclitaxel/cisplatin regimen is superior to standard therapy PC based on higher overall response rates, higher negative second-look laparotomy rate and overall survival. The regimen paclitaxel/cisplatin/cyclophosphamide seem to give the best treatment results. Interval debulking surgery after initial laparotomy and intraperitoneal therapy with cisplatin and i.v. cyclophosphamide in patients with residual disease improve overall survival rate.
Is platinum-based chemotherapy with paclitaxel effective in optimally debulked patients with advanced ovarian cancer? [2019]Suboptimally debulked patients with advanced ovarian cancer who are treated with a combination of cisplatin plus paclitaxel (TP therapy) have a better survival as compared to patients treated with a combination of cisplatin plus cyclophosphamide (CP therapy), but this advantage has not been demonstrated in optimally debulked patients. We performed a retrospective study to compare the effectiveness of TP therapy and CP therapy in optimally debulked patients.
Advanced cytoreduction as surgical standard of care and hyperthermic intraperitoneal chemotherapy as promising treatment in epithelial ovarian cancer. [2019]Favorable oncological outcomes have been reported in several trials with the introduction of Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the treatment of Advanced Epithelial Ovarian Cancer (EOC). However most of the studies testing the combined approach are observational and have been conducted in inhomogeneous series so that the evidence supporting the performance of this combined treatment is still poor. Median Overall and Disease Free Survivals of up to 64 months and 57 months, respectively have been reported. Although a rate of morbidity of up to 40% has been observed in some series the CRS + HIPEC continues to gain an increased popularity. Several prospective randomized trials are ongoing using the procedure in various time points of the disease. In this review several issues such as the impact of cytoreduction and residual disease (RD) on outcomes as well as the role of HIPEC will be updated from the literature evidence. Some controversial points HIPEC related will also be discussed. Recent experiences regarding the introduction of a more aggressive surgical approach to upper abdomen to resect peritoneal carcinomatosis (PC) allowed increased rates of optimal cytoreduction and has demonstrated an apparent better outcome. This evidence associated with the positive results phase III trial testing normothermic intraperitoneal as first-line chemotherapy is guiding some investigators to propose the CRS + HIPEC in the primary setting. Several prospective phase II and III trials have recently been launched to validate the role of the combined treatment in various time points of disease natural evolution.
HIPEC in recurrent ovarian cancer patients: morbidity-related treatment and long-term analysis of clinical outcome. [2022]To evaluate morbidity and mortality rates associated with the use of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) after optimal cytoreduction (CRS) in a large single-institutional series of platinum-sensitive recurrent ovarian cancer patients. Moreover, disease free (DFS) and overall survival (OS) of previously studied patients have been assessed after a longer follow-up period.
Hyperthermic intraperitoneal chemotherapy with cisplatin and paclitaxel in advanced ovarian cancer: a multicenter prospective observational study. [2022]Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) have been recently reported with favorable oncological outcomes as treatment of advanced epithelial ovarian cancer (EOC). The aim of this study was to demonstrate the feasibility of CRS+HIPEC with cisplatin and paclitaxel for the treatment of advanced EOC.
Hyperthermic intraperitoneal chemotherapy with paclitaxel or cisplatin in patients with stage III-C/IV ovarian cancer. Is there any difference? [2022]To compare the results of the administration of HIPEC with Paclitaxel or Cisplatin after cytoreduction in patients with stage IIIC-IV ovarian cancer, especially focused on disease-free survival.
A Retrospective Clinical Analysis of Hyperthermic Intraperitoneal Chemotherapy in Gynecological Cancers: Technical Details, Tolerability, and Efficacy. [2022]The aim of this study was to reveal the results of hyperthermic intraperitoneal chemotherapy (HIPEC procedure) performed during cytoreductive surgery (CRS) in patients with endometrial cancer and epithelial ovarian cancer which included mainly platinum-resistant patients.
Hyperthermic Intrathoracic Chemotherapy (HITOC) after Cytoreductive Surgery for Pleural Malignancies-A Retrospective, Multicentre Study. [2021]In the context of quality assurance, the objectives were to describe the surgical treatment and postoperative morbidity (particularly renal insufficiency). A retrospective, multicentre study of patients who underwent cytoreductive surgery (CRS) with cisplatin-based HITOC was performed. The study was funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation (GZ: RI 2905/3-1)). Patients (n = 350) with malignant pleural mesothelioma (n = 261; 75%) and thymic tumours with pleural spread (n = 58; 17%) or pleural metastases (n = 31; 9%) were analyzed. CRS was accomplished by pleurectomy/decortication (P/D: n = 77; 22%), extended P/D (eP/D: n = 263; 75%) or extrapleural pneumonectomy (EPP: n = 10; 3%). Patients received cisplatin alone (n = 212; 61%) or cisplatin plus doxorubicin (n = 138; 39%). Low-dose cisplatin (≤125 mg/m2 BSA) was given in 67% of patients (n = 234), and high-dose cisplatin (>125 mg/m2 BSA) was given in 33% of patients (n = 116). Postoperative renal insufficiency appeared in 12% of the patients (n = 41), and 1.4% (n = 5) required temporary dialysis. Surgical revision was necessary in 51 patients (15%). In-hospital mortality was 3.7% (n = 13). Patients receiving high-dose cisplatin were 2.7 times more likely to suffer from renal insufficiency than patients receiving low-dose cisplatin (p = 0.006). The risk for postoperative renal failure is dependent on the intrathoracic cisplatin dosage but was within an acceptable range.