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Ovarian CancerPhase 2NCT02249013

Short-course HIPEC in Advanced Epithelial Ovarian Cancer

A Phase 2 study testing Cytoreductive Surgery (CRS), Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Neoadjuvant Chemotherapy (NACT) in people with Ovarian Cancer, run by Professor Fernando Figueira Integral Medicine Institute.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Ovarian Cancer
What is being tested?
Cytoreductive Surgery (CRS), Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Neoadjuvant Chemotherapy (NACT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
Feb 2015to 23 Feb 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

About this study

Official title: Short-course Hyperthermic IntraPEritoneal Chemotherapy (HIPEC) at Interval Debulking Surgery for High Tumor Burden Ovarian Cancer

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).

Read the 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.

Conditions
Ovarian Cancer
Being tested
Cytoreductive Surgery (CRS), Hyperthermic Intraperitoneal Chemotherapy (HIPEC), Neoadjuvant Chemotherapy (NACT), Adjuvant Chemotherapy, Fast-track recovery strategy
Keywords
Ovarian Cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cytoreductive Surgery (CRS)Procedure or surgery

    CRS was performed with standard peritonectomy procedures and visceral resections directed towards complete elimination of tumors from the abdominopelvic cavity.

  • Hyperthermic Intraperitoneal Chemotherapy (HIPEC)Procedure or surgery

    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.

  • Neoadjuvant Chemotherapy (NACT)Drug

    Also called Carboplatin, Paclitaxel

    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.

  • Adjuvant ChemotherapyDrug

    Also called Carboplatin, Paclitaxel

    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.

  • Fast-track recovery strategyProcedure or surgery

    A comprehensive fast-track program was applied to accelerate recovery, reduce morbidity, and shorten convalescence for patients enrolled in our trial.

Study groups in NCT02249013
Study groupRoleWhat they receive
HIPECExperimentalNeoadjuvant Chemotherapy (NACT) followed by Cytoreductive Surgery (CRS) under a Fast-track recovery strategy plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and thus, Adjuvant Chemotherapy
Receives: Procedure: Cytoreductive Surgery (CRS); Procedure: Hyperthermic Intraperitoneal Chemotherapy (HIPEC); Drug: Neoadjuvant Chemotherapy (NACT); Drug: Adjuvant Chemotherapy; Procedure: Fast-track recovery strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PD9

    Proportion of patients with disease progression or death occurring within 9 months of IDS plus HIPEC

    Measured: 9 months

Secondary outcomes (6)

  1. Postoperative 30-day mortality rate

    Mortality rates up to 30-day after surgery

    Measured: 30 days

  2. Postoperative complication rates

    Complications rates up to 30-day after surgery

    Measured: 30 days

  3. Assessment of quality of life (QLQ-C30/EORTC)

    Assessment of quality of life according to the QLQ-C30/EORTC scales.

    Measured: 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

  4. Overall survival (OS)

    We defined OS as the time from starting the NACT to death.

    Measured: 24 months

  5. Progression-free Survival (PFS)

    We defined PFS as the time from starting the NACT to disease progression.

    Measured: 24 months

  6. Disease-free Survival (DFS)

    We defined DFS for patients without no gross residual disease as the time from IDS plus HIPEC to disease progression.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completion23 Feb 2021
  4. Study completion23 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02249013
Sponsor's protocol ID
U1111-1158-0472
Other IDs
18388113.4.0000.5201
Status last verified
Mar 2021
First submitted
22 Sep 2014
Last updated
18 Mar 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: We have no plan to make individual participant data (IPD) available to other researchers.

Publications

  • Batista TP, Carneiro VCG, Tancredi R, Teles ALB, Badiglian-Filho L, Leao CS. Neoadjuvant chemotherapy followed by fast-track cytoreductive surgery plus short-course hyperthermic intraperitoneal chemotherapy (HIPEC) in advanced ovarian cancer: preliminary results of a promising all-in-one approach. Cancer Manag Res. 2017 Dec 13;9:869-878. doi: 10.2147/CMAR.S153327. eCollection 2017.

    PubMed 29263704

  • Batista TP, Badiglian Filho L, Leao CS. Exploring flow rate selection in HIPEC procedures. Rev Col Bras Cir. 2016 Dec;43(6):476-479. doi: 10.1590/0100-69912016006014. English, Portuguese.

    PubMed 28273222

  • Lustosa RJC, Batista TP, Carneiro VCG, Badiglian-Filho L, Costa RLR, Lopes A, Sarmento BJQ, Lima JTO, Mello MJG, LeAo CS. Quality of life in a phase 2 trial of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) at interval debulking surgery for high tumor burden ovarian cancer. Rev Col Bras Cir. 2020;47:e20202534. doi: 10.1590/0100-6991e-20202534. Epub 2020 Jul 10. English, Portuguese.

    PubMed 32667582

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cytoreductive Surgery (CRS), Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Neoadjuvant Chemotherapy (NACT) in people with Ovarian Cancer, run by Professor Fernando Figueira Integral Medicine Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PD9 (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02249013, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.

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