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

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

Brief Summary:
Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Drug: HIPEC Procedure: No HIPEC Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel for the Treatment of Patients With Recurrent or Primary Advanced Ovarian Cancer : A Randomised Phase 3 Study
Actual Study Start Date : January 2012
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: HIPEC
Primary ovarian cancer FIGO stage II, III or IV or recurrent
Drug: HIPEC
Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Paclitaxel (175 mg/m2) for 60 minutes at 42-43 degrees.

Active Comparator: No HIPEC
Primary ovarian cancer FIGO stage II, III or IV or recurrent
Procedure: No HIPEC
Cytoreductive surgery without HIPEC




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT02681432


Contacts
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Contact: Pedro Villarejo Campos, MD,PhD 926278000 ext 79784 villarejocampos@yahoo.es

Locations
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Spain
Hospital General Ciudad Real Recruiting
Ciudad Real, Spain, 13005
Contact: Javier Redondo-Calvo, MD PhD         
Principal Investigator: Pedro Villarejo Campos, MD,PhD         
Sub-Investigator: Javier Redondo Calvo, MD,PhD         
Sponsors and Collaborators
PEDRO VILLAREJO CAMPOS
Hospital General de Ciudad Real
University of Castilla-La Mancha
Investigators
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Principal Investigator: Pedro Villarejo Campos, MD, PhD SESCAM

Publications:

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Responsible Party: PEDRO VILLAREJO CAMPOS, MD, PhD.Associate Professor of Surgery. University of Castilla-La Mancha, Hospital General de Ciudad Real
ClinicalTrials.gov Identifier: NCT02681432     History of Changes
Other Study ID Numbers: HGCRCIRU001
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by PEDRO VILLAREJO CAMPOS, Hospital General de Ciudad Real:
HIPEC
ovarian cancer
peritoneal carcinomatosis
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action