We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
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 : Completed
First Posted : September 25, 2014
Last Update Posted : March 18, 2021
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is an open-label, multicenter, single-arm, feasibility 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).

Condition or disease Intervention/treatment Phase
Ovarian Cancer Procedure: Cytoreductive Surgery (CRS) Procedure: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Drug: Neoadjuvant Chemotherapy (NACT) Drug: Adjuvant Chemotherapy Procedure: Fast-track recovery strategy Phase 2

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, we explore 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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short-course Hyperthermic IntraPEritoneal Chemotherapy (HIPEC) at Interval Debulking Surgery for High Tumor Burden Ovarian Cancer
Actual Study Start Date : February 2015
Actual Primary Completion Date : February 23, 2021
Actual Study Completion Date : February 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. PD9 [ Time Frame: 9 months ]
    Proportion of patients with disease progression or death occurring within 9 months of IDS plus HIPEC


Secondary Outcome Measures :
  1. Postoperative 30-day mortality rate [ Time Frame: 30 days ]
    Mortality rates up to 30-day after surgery

  2. Postoperative complication rates [ Time Frame: 30 days ]
    Complications rates up to 30-day after surgery

  3. 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.

  4. Overall survival (OS) [ Time Frame: 24 months ]
    We defined OS as the time from starting the NACT to death.

  5. Progression-free Survival (PFS) [ Time Frame: 24 months ]
    We defined PFS as the time from starting the NACT to disease progression.

  6. 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.


Other Outcome Measures:
  1. Time to start chemotherapy after surgery [ Time Frame: An expected range of 4 to 8 weeks ]
    Time to start adjuvant chemotherapy after surgery (CRS).

  2. Length of ICU and hospital stay [ Time Frame: An expected range of 5 to 30 days ]
    Length of ICU and hospital stay.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02249013


Sponsors and Collaborators
Professor Fernando Figueira Integral Medicine Institute
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
Layout table for investigator information
Principal Investigator: Thales P Batista, MD, MS Professor Fernando Figueira Integral Medicine Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Layout table for additonal information
Responsible Party: Thales Paulo Batista, Consultant Physician and Researcher, Professor Fernando Figueira Integral Medicine Institute
ClinicalTrials.gov Identifier: NCT02249013    
Other Study ID Numbers: U1111-1158-0472
18388113.4.0000.5201 ( Other Identifier: CAAE )
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We have no plan to make individual participant data (IPD) available to other researchers.
Keywords provided by Thales Paulo Batista, Professor Fernando Figueira Integral Medicine Institute:
Ovarian Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action