HIPEC with Surgery for Ovarian Cancer
(OVHIPEC-2 Trial)
Recruiting in Palo Alto (17 mi)
+29 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: The Netherlands Cancer Institute
Disqualifiers: Previous malignancies, Stage IV disease, others
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment HIPEC with Surgery for Ovarian Cancer?
Research shows that combining cytoreductive surgery (removal of as much of the tumor as possible) with hyperthermic intraperitoneal chemotherapy (HIPEC) using cisplatin has favorable outcomes for advanced ovarian cancer. Additionally, cisplatin is effective in treating advanced stages of ovarian cancer, improving survival rates when used after surgery.
12345Is HIPEC with surgery for ovarian cancer safe for humans?
The treatment involving cisplatin, used in HIPEC with surgery, has shown some side effects such as vomiting, nausea, and hair loss, and can affect the digestive and kidney systems. In a study, 12% of patients experienced kidney issues, with a small percentage needing temporary dialysis, but these risks were considered within an acceptable range.
678910How is the HIPEC with Surgery treatment for ovarian cancer different from other treatments?
HIPEC with Surgery for ovarian cancer is unique because it combines surgery to remove as much of the tumor as possible (cytoreductive surgery) with heated chemotherapy (HIPEC) directly applied inside the abdomen, which may enhance the effectiveness of the chemotherapy and target cancer cells more directly compared to traditional intravenous chemotherapy.
311121314Eligibility 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
I am a candidate for major surgery to remove cancer.
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.
I have not had any other cancers in the last 5 years.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo primary cytoreductive surgery with or without HIPEC
4-6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
30 days
Long-term follow-up
Participants are monitored for long-term outcomes and cost evaluation
1 year
Participant Groups
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
[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.
[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.
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.
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.
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.
[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.
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.
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.
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.
[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.
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 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.
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 (HIPEC): New Approaches and Controversies on the Treatment of Advanced Epithelial Ovarian Cancer-Systematic Review and Meta-Analysis. [2023]Hyperthermic intraperitoneal chemotherapy (HIPEC) after cytoreductive surgery has been extensively studied in patients with peritoneal carcinomatosis, and it holds promise as a therapeutic strategy, but its role remains elusive. The aim of this study was to assess the existing evidence for the use or not of HIPEC in primary debulking surgery (PDS), interval debulking surgery (IDS), and recurrent ovarian cancer (ROC), evaluated in terms of survival rates and post-surgical morbidity.