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Hyperthermic Intraperitoneal Chemotherapy for Treatment of Relapsed Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717610
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Collaborators:
Uppsala University
Karolinska Institutet
The Netherlands Cancer Institute
Information provided by (Responsible Party):
Marta Lomnytska, Uppsala University Hospital

Brief Summary:
This is a feasibility single-center study to investigate the tolerability, toxicity, quality of life, morbidity, mortality of the HIPEC treatment following cytoreductive surgery for treatment of recurrent ovarian, peritoneal, and fallopian tube cancers.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Recurrent Procedure: radical surgery with HIPEC Phase 3

Detailed Description:

Ovarian cancer is the leading cause of gynecological cancer mortality; it is in 75% of cases detected at advanced stages. The standard treatment is cytoreductive surgery with removal of macroscopic tumor, and intravenous chemotherapy. Three randomized trials observed survival gain for ovarian cancer patients that received intraperitoneal chemotherapy after the optimal cytoreduction, however catheter-related complications made the procedure not feasible. A "one-time" hyperthermic intraperitoneal chemotherapy, HIPEC, is an established for peritoneal carcinosis in colorectal cancer, and recently two phase III randomised clinical studies observe survival gain also for ovarian cancer patients after surgery with HIPEC.

Here the investigators, plan to investigate the HIPEC procedure following cytoreductive surgery for recurrent ovarian cancer, a progressed disease without any standard treatment established.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Intraoperative Given Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin During a Cytoreductive Surgery in Patients With Recurrent Ovarian, Peritoneal or Fallopian Tube Cancers
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: radical surgery with HIPEC
After achieved macroscopically radical surgery, HIPEC procedure will be performed
Procedure: radical surgery with HIPEC
Straight after macroscopic radical cytoreductive surgery, an intraperitoneal hyperthermic perfusion using the open-abdomen technique will be performed with a single dose of cisplatin 100 mg/m2 administered for 90 minutes in the hyperthermic phase (41°C-43°C).




Primary Outcome Measures :
  1. Treatment-related toxicities [ Time Frame: 3 months after surgery ]
    Registration of the effects according to NCI CTCAEv4.0 guidelines.


Secondary Outcome Measures :
  1. Assessment of quality of life [ Time Frame: before surgery, and 4 weeks, 3 months and 6 months after surgery ]
    EORTC C30 quality of life questionnaire

  2. Assessment of quality of life in relation to ovarian cancer [ Time Frame: before surgery, and 4 weeks, 3 months and 6 months after surgery ]
    EORTC OV28 quality of life questionnaire

  3. Assessment of quality of Life in relation to eventually performed intestinal surgery [ Time Frame: before surgery, and 4 weeks, 3 months and 6 months after surgery ]
    EORTC CR29 quality of life questionnaire

  4. Morbidity [ Time Frame: 30 days after surgery ]
    Rate of the high-grade 3 and 4 complications, according to the Clawien-Dindo scale

  5. Mortality [ Time Frame: 90 days after surgery ]
    Number of participants with lethal outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with diagnosis of recurrent epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma after 6 month since platinum-based chemotherapy (first recurrence) and are scheduled for secondary surgical evaluation/cytoreduction
  • ECOG/WHO Performance score of 0 to 1
  • Adequate respiratory, hepatic, cardiac, kidney and bone marrow function ( Hb >= 8 g/dl, absolute neutrophil count > 1500/mm3, platelets > 100,000/mm3, creatinine clearance > 60 mL/min according to Cockroft formula)
  • Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L
  • Histological types feature would be serous, endometrioid, clear cell, undifferentiated carcinomas, transitional cell carcinoma, or mixed epithelial carcinoma
  • No end organ function
  • Patients must have less than or equal to 2.5 mm residual disease at the completion of the cytoreductive surgery to be eligible for the study
  • Patient-compliant and psychologically able to follow the trial procedures, signature of informed consent.

Exclusion Criteria:

  • Evidence of extensive retroperitoneal lymph node disease
  • Neuropsychiatric disorders;
  • Pregnancy or breast feeding.
  • Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
  • Subjects with invasive malignancies or had any evidence of the other cancer present within the last 3 years. Prior radiation for localized cancer of the breast, head and neck, or skin are permitted, provided that it was completed more than 3 years prior to enrollment, and the subject remains free of recurrent or metastatic disease
  • Subjects with active infection that requires parenteral antibiotics
  • Tumors of low malignant potential, or non-invasive borderline tumors
  • Patients with any underlying cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions, chronic or latent infectious diseases, immune deficiency, or history, which in the opinion of the investigator, places the patient at an unacceptable risk for participation in the study
  • Patient with extra-abdominal metastatic disease
  • Known platinum (carboplatin or cisplatin) allergy
  • Life expectancy < 3 months
  • Still, it will not be considered for the HIPEC protocol those patients with unresectable disease (presence of invasive peritoneal implants inoperable or at high risk for resection in critical locations such as hepatic hilum, the mesenteric root, trunk celiac, mesentery, and several small implants the serosa of the small intestine) and / or with residual disease after cytoreduction greater than or equal to 2.5 mm (CC-2 and CC-3).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717610


Contacts
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Contact: Marta Lomnytska, MD, PhD 018-611 00 00 ext +46 marta.lomnytska@akademiska.se

Locations
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Sweden
Uppsala University Hopsital Recruiting
Uppsala, Sweden, 75185
Contact: Marta Lomnytska, PhD    018-611 00 00 ext +46    marta.lomnytska@akademiska.se   
Contact: Ilvars Silins, PhD    018-611 00 00 ext +46    ilvars.silins@akademiska.se   
Sub-Investigator: Wilhelm Graf, Professor         
Sponsors and Collaborators
Uppsala University Hospital
Uppsala University
Karolinska Institutet
The Netherlands Cancer Institute

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Responsible Party: Marta Lomnytska, Principal Investigator, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT03717610    
Other Study ID Numbers: 077/2018
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cisplatin
Antineoplastic Agents