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Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer (hipecova)

Primary Purpose

Epithelial Ovarian Cancer

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
HIPEC
No HIPEC
Sponsored by
PEDRO VILLAREJO CAMPOS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring HIPEC, ovarian cancer, peritoneal carcinomatosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with histologically confirmed epithelial ovarian cancer (stage II / III / IV disease of FIGO) or tumor recurrences (the women of childbearing age need to have a negative pregnancy test)
  • Complete cytoreduction: Index CC0/CC1 cytoreduction (residual tumor size after surgery, no visible (CC0) or less than 0.25 cm (CC1))
  • No extra-abdominal tumor disease
  • Absence of heart failure. Adequate renal and hepatic functions
  • Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%

Exclusion Criteria:

  • Patients with unresectable tumor or incomplete cytoreduction.
  • Contraindications for treatment with paclitaxel: patients with severe hypersensitivity to paclitaxel or any of the excipients,pregnancy or lactation and patients with baseline neutrophil count <1.500/mm3 (<1.000/mm3 for patients with Kaposi sarcoma). Paclitaxel is also contraindicated in patients who have concurrent and severe infections.
  • Extra-abdominal metastases or unresectable liver metastases
  • Presence of other malignant tumor disease.
  • Multisegmental complete bowel obstruction.
  • Patients with severe medical problems that will preclude compliance with the study or with an unacceptable risk
  • Patients who refuse treatment or consent to participate in study

Sites / Locations

  • Hospital General Ciudad RealRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HIPEC

No HIPEC

Arm Description

Primary ovarian cancer FIGO stage II, III or IV or recurrent

Primary ovarian cancer FIGO stage II, III or IV or recurrent

Outcomes

Primary Outcome Measures

Overall survival
From the date of surgery to the date of death or to the end of study (follow up every 6 months till 3 years)

Secondary Outcome Measures

Progression free survival
From the date of surgery to the date of recurrence or to the end of study (follow up every 6 months till 18 months)

Full Information

First Posted
January 25, 2016
Last Updated
August 17, 2018
Sponsor
PEDRO VILLAREJO CAMPOS
Collaborators
Hospital General de Ciudad Real, University of Castilla-La Mancha
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1. Study Identification

Unique Protocol Identification Number
NCT02681432
Brief Title
Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer
Acronym
hipecova
Official Title
Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel for the Treatment of Patients With Recurrent or Primary Advanced Ovarian Cancer : A Randomised Phase 3 Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
PEDRO VILLAREJO CAMPOS
Collaborators
Hospital General de Ciudad Real, University of Castilla-La Mancha

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.
Detailed Description
Randomized clinical trial performed in woman with epithelial primary ovarian cancer (stage FIGO II, III and IV) or tumor recurrence. A cytoreductive surgery will be perform in all of the patients include in the trial, and it will be assign at randomization: HIPEC-arm: cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with paclitaxel (175 mg / m2) for 60 minutes at a temperature of 42-43º degrees; followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles. No HIPEC-arm: Cytoreductive surgery followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer
Keywords
HIPEC, ovarian cancer, peritoneal carcinomatosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIPEC
Arm Type
Experimental
Arm Description
Primary ovarian cancer FIGO stage II, III or IV or recurrent
Arm Title
No HIPEC
Arm Type
Active Comparator
Arm Description
Primary ovarian cancer FIGO stage II, III or IV or recurrent
Intervention Type
Drug
Intervention Name(s)
HIPEC
Intervention Description
Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Paclitaxel (175 mg/m2) for 60 minutes at 42-43 degrees.
Intervention Type
Procedure
Intervention Name(s)
No HIPEC
Intervention Description
Cytoreductive surgery without HIPEC
Primary Outcome Measure Information:
Title
Overall survival
Description
From the date of surgery to the date of death or to the end of study (follow up every 6 months till 3 years)
Time Frame
every 6 months till 36 months
Secondary Outcome Measure Information:
Title
Progression free survival
Description
From the date of surgery to the date of recurrence or to the end of study (follow up every 6 months till 18 months)
Time Frame
follow up every 6 months till 18 months
Other Pre-specified Outcome Measures:
Title
Post-operative complications
Description
Compare adverse events between study arms
Time Frame
adverse events within 30 days postoperatively (according to NCI criteria, Common Terminology Criteria for AE (CTCAE))

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with histologically confirmed epithelial ovarian cancer (stage II / III / IV disease of FIGO) or tumor recurrences (the women of childbearing age need to have a negative pregnancy test) Complete cytoreduction: Index CC0/CC1 cytoreduction (residual tumor size after surgery, no visible (CC0) or less than 0.25 cm (CC1)) No extra-abdominal tumor disease Absence of heart failure. Adequate renal and hepatic functions Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70% Exclusion Criteria: Patients with unresectable tumor or incomplete cytoreduction. Contraindications for treatment with paclitaxel: patients with severe hypersensitivity to paclitaxel or any of the excipients,pregnancy or lactation and patients with baseline neutrophil count <1.500/mm3 (<1.000/mm3 for patients with Kaposi sarcoma). Paclitaxel is also contraindicated in patients who have concurrent and severe infections. Extra-abdominal metastases or unresectable liver metastases Presence of other malignant tumor disease. Multisegmental complete bowel obstruction. Patients with severe medical problems that will preclude compliance with the study or with an unacceptable risk Patients who refuse treatment or consent to participate in study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro Villarejo Campos, MD,PhD
Phone
926278000
Ext
79784
Email
villarejocampos@yahoo.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Villarejo Campos, MD, PhD
Organizational Affiliation
SESCAM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Ciudad Real
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Redondo-Calvo, MD PhD
First Name & Middle Initial & Last Name & Degree
Pedro Villarejo Campos, MD,PhD
First Name & Middle Initial & Last Name & Degree
Javier Redondo Calvo, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19917539
Citation
Munoz-Casares FC, Rufian S, Rubio MJ, Diaz CJ, Diaz R, Casado A, Arjona A, Munoz-Villanueva MC, Muntane J. The role of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) in the treatment of peritoneal carcinomatosis in recurrent ovarian cancer. Clin Transl Oncol. 2009 Nov;11(11):753-9. doi: 10.1007/s12094-009-0438-3.
Results Reference
background
PubMed Identifier
26755441
Citation
Jaaback K, Johnson N, Lawrie TA. Intraperitoneal chemotherapy for the initial management of primary epithelial ovarian cancer. Cochrane Database Syst Rev. 2016 Jan 12;2016(1):CD005340. doi: 10.1002/14651858.CD005340.pub4.
Results Reference
background
PubMed Identifier
16394300
Citation
Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.
Results Reference
background
PubMed Identifier
19701772
Citation
Chua TC, Robertson G, Liauw W, Farrell R, Yan TD, Morris DL. Intraoperative hyperthermic intraperitoneal chemotherapy after cytoreductive surgery in ovarian cancer peritoneal carcinomatosis: systematic review of current results. J Cancer Res Clin Oncol. 2009 Dec;135(12):1637-45. doi: 10.1007/s00432-009-0667-4. Epub 2009 Aug 23.
Results Reference
background
PubMed Identifier
17496308
Citation
Bijelic L, Jonson A, Sugarbaker PH. Systematic review of cytoreductive surgery and heated intraoperative intraperitoneal chemotherapy for treatment of peritoneal carcinomatosis in primary and recurrent ovarian cancer. Ann Oncol. 2007 Dec;18(12):1943-50. doi: 10.1093/annonc/mdm137. Epub 2007 May 11.
Results Reference
background
PubMed Identifier
20035540
Citation
Kim JH, Lee JM, Ryu KS, Lee YS, Park YG, Hur SY, Lee KH, Lee SH, Kim SJ. Consolidation hyperthermic intraperitoneal chemotherapy using paclitaxel in patients with epithelial ovarian cancer. J Surg Oncol. 2010 Feb 1;101(2):149-55. doi: 10.1002/jso.21448.
Results Reference
background
PubMed Identifier
20185937
Citation
Benedetti Panici P, Palaia I, Graziano M, Bellati F, Manci N, Angioli R. Intraperitoneal paclitaxel as consolidation treatment in ovarian cancer patients: a case control study. Oncology. 2010;78(1):20-5. doi: 10.1159/000287968. Epub 2010 Feb 24.
Results Reference
background
PubMed Identifier
18239973
Citation
de Bree E, Rosing H, Filis D, Romanos J, Melisssourgaki M, Daskalakis M, Pilatou M, Sanidas E, Taflampas P, Kalbakis K, Beijnen JH, Tsiftsis DD. Cytoreductive surgery and intraoperative hyperthermic intraperitoneal chemotherapy with paclitaxel: a clinical and pharmacokinetic study. Ann Surg Oncol. 2008 Apr;15(4):1183-92. doi: 10.1245/s10434-007-9792-y. Epub 2008 Feb 1.
Results Reference
background
PubMed Identifier
25242382
Citation
Seretis C, Youssef H. Quality of life after cytoreductive surgery and intraoperative hyperthermic intraperitoneal chemotherapy for peritoneal surface malignancies: a systematic review. Eur J Surg Oncol. 2014 Dec;40(12):1605-13. doi: 10.1016/j.ejso.2014.08.477. Epub 2014 Sep 6.
Results Reference
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Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer

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