Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Short-course HIPEC in Advanced Epithelial 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02249013
Recruitment Status : Active, not recruiting
First Posted : September 25, 2014
Last Update Posted : December 17, 2019
Sponsor:
Collaborators:
Hospital de Câncer de Pernambuco (Recife/PE)
AC Camargo Cancer Center (São Paulo/SP)
Instituto Brasileiro de Controle do Câncer (São Paulo/SP)
Hospital de Cancer de Barretos - Fundacao Pio XII (Barretos/SP)
Hospital Sao Jose (Criciuma/SC)
Hospital de Base do Distrito Federal (Brasilia/DF)
Information provided by (Responsible Party):
Thales Paulo Batista, Professor Fernando Figueira Integral Medicine Institute

Tracking Information
First Submitted Date  ICMJE September 22, 2014
First Posted Date  ICMJE September 25, 2014
Last Update Posted Date December 17, 2019
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2019)
PD9 [ Time Frame: 9 months ]
Proportion of patients with disease progression or death occurring within 9 months of IDS plus HIPEC
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2014)
Progression-free survival [ Time Frame: 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2019)
  • Postoperative 30-day mortality rate [ Time Frame: 30 days ]
    Mortality rates up to 30-day after surgery
  • Postoperative complication rates [ Time Frame: 30 days ]
    Complications rates up to 30-day after surgery
  • Assessment of quality of life (QLQ-C30/EORTC) [ Time Frame: Baseline (i.e., at the time of hospital admission for IDS plus HIPEC); after CRS/HIPEC (i.e., at the time of restarting the systemic chemotherapy); after protocol (i.e., at 3-6 weeks after the last syst ]
    Assessment of quality of life according to the QLQ-C30/EORTC scales.
  • Overall survival (OS) [ Time Frame: 24 months ]
    We defined OS as the time from starting the NACT to death.
  • Progression-free Survival (PFS) [ Time Frame: 24 months ]
    We defined PFS as the time from starting the NACT to disease progression.
  • Disease-free Survival (DFS) [ Time Frame: 24 months ]
    We defined DFS for patients without no gross residual disease as the time from IDS plus HIPEC to disease progression.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2014)
  • Postoperative 30-day mortality rate [ Time Frame: 30 days ]
  • Postoperative complication rates [ Time Frame: 3 months ]
  • Assessment of quality of life (QLQ-C30/EORTC) [ Time Frame: Baseline, 1, 3, 6, and 12 weeks after procedures ]
  • Overall survival [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures
 (submitted: January 14, 2018)
  • Time to start chemotherapy after surgery [ Time Frame: An expected range of 4 to 8 weeks ]
    Time to start adjuvant chemotherapy after surgery (CRS).
  • Length of ICU and hospital stay [ Time Frame: An expected range of 5 to 30 days ]
    Length of ICU and hospital stay.
Original Other Pre-specified Outcome Measures
 (submitted: September 23, 2014)
  • Time to start chemotherapy after surgery [ Time Frame: An expected range of 4 to 8 weeks ]
  • Length of ICU and hospital stay [ Time Frame: An expected range of 5 to 30 days ]
 
Descriptive Information
Brief Title  ICMJE Short-course HIPEC in Advanced Epithelial Ovarian Cancer
Official Title  ICMJE Short-course Hyperthermic IntraPEritoneal Chemotherapy (HIPEC) at Interval Debulking Surgery for High Tumor Burden Ovarian Cancer
Brief Summary This was an open-label, multicenter, single-arm, phase 2 trial on safety and efficacy of short-course regimen of intra-operative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at the time of fast-track interval debulking surgery (IDS) following neoadjuvant chemotherapy (NACT) for high tumor burden epithelial ovarian cancer (EOC).
Detailed Description This study was initially designed to explore the safety and efficacy of short-course HIPEC in terms of median progression-free survival (PFS) as the primary outcome. However, due to slow accrual, the design was subsequently amended to explore the primary outcome measure of PD9 (i.e.: proportion of patients with disease progression or death occurring within 9 months of IDS plus HIPEC). The hypothesis was the short-course HIPEC could decrease PD9 with low rates of morbidity and mortality. In these settings, a comprehensive treatment approach involving fast-track advanced cytoreductive surgery (CRS) plus short-course HIPEC at the time of IDS following NACT for high tumor burden patients with stage III-IV ovarian cancer. Advanced CRS was performed with standard peritonectomy procedures and visceral resections directed towards complete elimination of tumors from the abdominopelvic cavity, and fast-track recovery strategies were also applied to improve patient outcomes. HIPEC was performed according to the closed-abdomen technique using CDDP (25 mg/L of perfusate/m2, total limit of 240mg) or CDDP plus Doxorubicin (15mg/L) for 30 minutes, with an intra-abdominal target temperature of 41-43°C. Perfusate (2L/m2, ranging from 4L to 6L) was circulated using an extracorporeal circulation device (Performer HT; RAND, Medolla, Italy) at a flow rate of 700 ml/min. Systemic chemotherapy included the standard combination of carboplatin and paclitaxel as neo-adjuvant plus adjuvant regimens.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Procedure: Cytoreductive Surgery (CRS)
    CRS was performed with standard peritonectomy procedures and visceral resections directed towards complete elimination of tumors from the abdominopelvic cavity.
  • Procedure: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
    HIPEC was performed according to the closed-abdomen technique using CDDP (25 mg/L of perfusate/m2, total limit of 240mg) for the first 10 patients and thus, using CDDP plus Doxorubicin (15mg/L) thereafter, both for 30 minutes, with an intra-abdominal target temperature of 41-43°C. Perfusate (2L/m2, ranging from 4L to 6L) was circulated using an extracorporeal circulation device (Performer HT; RAND, Medolla, Italy) at a flow rate of 700 ml/min.
  • Drug: Neoadjuvant Chemotherapy (NACT)
    Systemic chemotherapy included the standard combination of carboplatin (AUC 6) and paclitaxel (175 mg/m2) administered every 21 days as neoadjuvant (2-4 cycles) plus adjuvant regimens (2-4 cycles), in the total of 6 cycles of systemic chemotherapy.
    Other Names:
    • Carboplatin
    • Paclitaxel
  • Drug: Adjuvant Chemotherapy
    Systemic chemotherapy included the standard combination of carboplatin (AUC 6) and paclitaxel (175 mg/m2) administered every 21 days as neoadjuvant (2-4 cycles) plus adjuvant regimens (2-4 cycles), in the total of 6 cycles of systemic chemotherapy.
    Other Names:
    • Carboplatin
    • Paclitaxel
  • Procedure: Fast-track recovery strategy
    A comprehensive fast-track program was applied to accelerate recovery, reduce morbidity, and shorten convalescence for patients enrolled in our trial.
Study Arms  ICMJE Experimental: HIPEC
Neoadjuvant Chemotherapy (NACT) followed by Cytoreductive Surgery (CRS) under a Fast-track recovery strategy plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and thus, Adjuvant Chemotherapy
Interventions:
  • Procedure: Cytoreductive Surgery (CRS)
  • Procedure: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
  • Drug: Neoadjuvant Chemotherapy (NACT)
  • Drug: Adjuvant Chemotherapy
  • Procedure: Fast-track recovery strategy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 15, 2019)
15
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2014)
20
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • Inclusion Criteria:

    • Patients with no previous treatment and candidates for elective surgery with histological diagnosis of epithelial ovarian carcinoma;
    • Clinical stage IIIB to IV, without suspicion of extra-abdominal metastasis;
    • No other malignancies in activity;
    • No previous treatments such as radiation, chemotherapy (except neoadjuvant chemotherapy in the study protocol) or major abdominal surgery;
    • Absence of neuro-psychiatric disorders, history of drug allergies, and pregnancy or breast feeding;
    • Aged between 18 and 70 years;
    • Performance status 0-2 (ECOG, Eastern Cooperative Oncology Group) and / or greater than 70 points by the Karnofsky scale;
    • Appropriated cardio-respiratory, hepato-renal and hematological reserves;
    • Signing of the Consent Form.
  • Exclusion Criteria:

    • Evidence of extensive retroperitoneal lymph node involvement or unresectable disease (i.e., massive involvement of the small bowel, mesentery, or hepatic pedicle, and ureteral or biliary obstruction) at the time of CRS/HIPEC;
    • Residual disease after the CRS greater than or equal to 2.5 mm (CC-2 and CC-3);
    • Limiting obesity for CRS or HIPEC;
    • Disease progression, apparent or confirmed uncontrolled infection, or health impairment during NACT.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02249013
Other Study ID Numbers  ICMJE U1111-1158-0472
18388113.4.0000.5201 ( Other Identifier: CAAE )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: We have no plan to make individual participant data (IPD) available to other researchers.
Responsible Party Thales Paulo Batista, Professor Fernando Figueira Integral Medicine Institute
Study Sponsor  ICMJE Professor Fernando Figueira Integral Medicine Institute
Collaborators  ICMJE
  • Hospital de Câncer de Pernambuco (Recife/PE)
  • AC Camargo Cancer Center (São Paulo/SP)
  • Instituto Brasileiro de Controle do Câncer (São Paulo/SP)
  • Hospital de Cancer de Barretos - Fundacao Pio XII (Barretos/SP)
  • Hospital Sao Jose (Criciuma/SC)
  • Hospital de Base do Distrito Federal (Brasilia/DF)
Investigators  ICMJE
Principal Investigator: Thales P Batista, MD, MS Professor Fernando Figueira Integral Medicine Institute
PRS Account Professor Fernando Figueira Integral Medicine Institute
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP