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

• ClinicalTrials.gov Identifier: NCT02681432
• Recruitment Status: Unknown
• First Posted: February 12, 2016
• Last Update Posted: August 21, 2018
• Sponsor: PEDRO VILLAREJO CAMPOS
• Collaborators: Hospital General de Ciudad Real; University of Castilla-La Mancha
• Information provided by (Responsible Party): PEDRO VILLAREJO CAMPOS, Hospital General de Ciudad Real

Tracking Information

• First Submitted Date: January 25, 2016
• First Posted Date: February 12, 2016
• Last Update Posted Date: August 21, 2018
• Actual Study Start Date: January 2012
• Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 11, 2016)

Overall survival [ Time Frame: every 6 months till 36 months ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 11, 2016)

Progression free survival [ Time Frame: follow up every 6 months till 18 months ]

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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: February 11, 2016)

Post-operative complications [ Time Frame: adverse events within 30 days postoperatively (according to NCI criteria, Common Terminology Criteria for AE (CTCAE)) ]

Compare adverse events between study arms

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer
• Official Title: Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel for the Treatment of Patients With Recurrent or Primary Advanced Ovarian Cancer : A Randomised Phase 3 Study
• 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epithelial Ovarian Cancer

Intervention

• Drug: HIPEC
  Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Paclitaxel (175 mg/m2) for 60 minutes at 42-43 degrees.
• Procedure: No HIPEC
  Cytoreductive surgery without HIPEC

Study Arms

• Experimental: HIPEC
  Primary ovarian cancer FIGO stage II, III or IV or recurrent
  Intervention: Drug: HIPEC
• Active Comparator: No HIPEC
  Primary ovarian cancer FIGO stage II, III or IV or recurrent
  Intervention: Procedure: No HIPEC

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 17, 2018): 60
• Original Estimated Enrollment (submitted: February 11, 2016): 94
• Estimated Study Completion Date: December 2019
• Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT02681432
• Other Study ID Numbers: HGCRCIRU001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: PEDRO VILLAREJO CAMPOS, Hospital General de Ciudad Real
• Original Responsible Party: Same as current
• Current Study Sponsor: PEDRO VILLAREJO CAMPOS
• Original Study Sponsor: Same as current

Collaborators

• Hospital General de Ciudad Real
• University of Castilla-La Mancha

Investigators

• Principal Investigator: Pedro Villarejo Campos, MD, PhD; SESCAM

• PRS Account: Hospital General de Ciudad Real
• Verification Date: August 2018