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Epithelial Ovarian CancerPhase 2HIPECNCT02487849

HIPEC After Secondary Cytoreductive Operation in Patients With Platinum-sensitive Recurrence of Ovarian Carcinoma

A Phase 2 study testing HIPEC and Carboplatin in people with Epithelial Ovarian Cancer and Peritoneal Cancer, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The combination of optimal cytoreductive operation (according to Desktop II criteria), HIPEC with Carboplatin 800 mg/m² KOF (Körperoberfläche) and following platinum-based systemic chemotherapy should be executed In patients with platinum-sensitive recurrence of ovarian carcinoma. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
HIPEC and Carboplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteAustria
Study dates
Aug 2016to Aug 2016
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years
  • Signed informed consent
  • Patients with platinum-sensitive recurrence after 12-48 months after platinum-based firstline-chemotherapy of histological saved epithelial ovarian carcinoma, primary peritoneal carcinoma or tube carcinoma with planned cytoreductive operation
  • The following histological types can be included: serous, endometrioide, clear cell or undifferentiated carcinoma. Mixed epithelial carcinoma, malignant Brenner Tumour
  • No preceding recurrence chemotherapy
  • Preceding hormontherapy admitted. Concomitant antineoplastic antihormone-therapy (Tamoxifen, Aromataseinhibitoren etc.) not admitted. Low dosed (physiological) hormone-replacement-therapie (HRT) can be administered
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  • Patients with maintenance therapy (e.g. Bevacizumab) permitted, assumed recurrence was diagnosed 12 months after primary cytotoxic chemotherapy (also with maintenancetherapy during chemotherapy) and last administration of maintenancetherapy happened min. 21 days before first study protocol intervention
  • Resectability R0 probably, fixed by Desktop II-criteria:
  • Cytoreductive operation at first-diagnosis of the carcinoma R0
  • Ascites <500 ml
  • ECOG 0
  • R0 status (≤0,5 cm tumour rest) at the end of secondary cytoreductive operation
  • Eligibility for Standard systemic platinum-based combination chemotherapy after sec. cytoreductive operation with or without HIPEC (investigators decision)
  • Bone marrow function: Haemoglobine ≥8.5 g/dL, Absol. neutrophile Granulocytes(ANC) ≥1.000/mm3, Thrombocytes ≥ 100.000/mm3
  • Renal function: Serum Creatinin ≤1,5 times the ULN, calculated Creatininclearance (GFR) ≥60ml/min
  • Liver function: Bilirubin ≤1,5 x
  • ALT, AST ≤3 x ULN
  • Adequate coagulation parameter: INR-value ≤1,5, aPTT ≤1,5 x ULN
  • For patients under fully-dosed/therapeutic Warfarin- or Phenprocoumontherapy INR between 2-3 and aPTT <1,2 x ULN
  • Neurol. Function: peripheral Neuropathy ≤Grade 2 (CTCAE v4.03 criteria)
  • In women with childbearing potential availability of a neg. serum pregnancy test 2 weeks before planned sec. cytored. operation + effective contraception during study period guaranteed

Who cannot join

  • No signed informed consent
  • Tumours with low malignant potential (Borderline-carzinomas)
  • Patients with preceding radiotherapy in abdomen and pelvis
  • Patients with preceding endometrial carcinoma will be excluded, except: Stage IA [no low differentiated subtype (serous-papillary, clear cellular, FIGO grade 3)]
  • With the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with other invasive malignancies, who had any evidence of the other cancer present within the last 3 years or whose previous cancer treatment contraindicates this protocol therapy, are excluded
  • Known acute hepatitis
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  • acute infectious disease with need for intravenous antibiosis
  • immunodeficiency
  • Active coronaryarterial disease: Myocardinfarct or instable Angina pectoris within 6 months before study inclusion: coronary artery disease in anamnesis can be included, assumed a normal stress-electrocardiogram finding within 30 days before study inclusion
  • Cardiac insufficiency NYHA ≥2 classif. of New York Heart Association
  • Hypertension ≥140/90 mm Hg
  • Poorly controlled cardiac arrythmia despite medication (patients with frequencey-controlled atrial fibrillation can participate)
  • Peripheral vascular disease ≥grade 3 (e.g. symptomatic and affecting activities of everyday-life, intervention or revision necessary)
  • Renal insufficiency Serumcreatininvalues ≥1,5 times the ULN or GFR <60ml/min
  • Cerebrovascular disease in anamnesis
  • Patients with another severe medical problem-independent of cancer-which excludes study participation
  • Known allergies to Carboplatin or Cisplatin
  • extended intraperitoneal adhesions at time of secondary cytoreductive operation, which makes administration of intraperitioneal chemotherapy impossible
  • Life expectancy <12 weeks

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Department of gynaecology, Ordensklinikum Linz Ges.m.b.H, Barmherzige Schwestern

    Linz, 4010

Other trials in Austria

About this study

Official title: Feasability of an Unique Intraoperative Given Hyperthermal Intraperitoneal Chemotherapy With Carboplatin During a Secondary Cytoreductive Operation in Patients With Platinum-sensitive Recurrence of Ovarian Carcinoma

The combination of optimal cytoreductive operation (according to Desktop II criteria), HIPEC with Carboplatin 800 mg/m² KOF (Körperoberfläche) and following platinum-based systemic chemotherapy should be executed In patients with platinum-sensitive recurrence of ovarian carcinoma. Condition for HIPEC is attainment of optimal cytoreduction (R0) and experts judgement of a complication-free prolongation of narcosis after finishing the surgery. HIPEC will be administered additionally to standard therapy. If HIPEC was executed the number of systemic given platinum-based chemotherapy decreases for one cycle.

This regime should be investigated in terms of safety of performance, quality of life for the patients and consequences for the following systemic chemotherapy.

Read the detailed description

In occurence with a platinum-sensitive recurrence of EOC survival can be prolonged by a recurrence-operation, if macroscopical tumor-free status (optimal cytoreductive operation) can be reached in combination with a platinum-based standard-chemotherapy.

Several studies showed that the combination of optimal cytoreductive operation and HIPEC is a secure method of treatment. In comparison to operation and standard-chemotherapy it has a significant positive influence on survival rates. A hyperthermal intraperitoneal chemotherapy with Carboplatin is possible without severe side-effects.

The combination of optimal cytoreductive operation (according to Desktop II criteria), HIPEC with Carboplatin and following platinum-based systemic chemotherapy should be carried out in patients with platinum-sensitive recurrence.

Condition for applying HIPEC is reaching optimal cytoreduction (<0.5 cm visible tumour rest at the end of operation) and according to expert opinion a complicatin-free prolongation of narcosis after finishing the operative intervention. HIPEC is carried out additionally to standard therapy. If it can be carried out, the amount of systemically administered patinum-based chemotherapy is reduced for one cycle.

This regime should be tested on safety in performance, quality of life for patients, and consequences for the following systemic chemotherapy.

Being tested
HIPEC, Carboplatin
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

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

  • HIPECProcedure or surgery

    Also called Hyperthermal intraperitoneal Chemotherapy

    secondary cytoreductive operation

  • CarboplatinDrug

    Also called Carboplatin Accord

    Hyperthermal Intraperitoneal Chemotherapy (HIPEC)

Study groups in NCT02487849
Study groupRoleWhat they receive
HIPECExperimentalIf patient is eligible - secondary cytoreductive operation will be followed by HIPEC with 800 mg/m² body surface (KOF) Carboplatin with closed technique.
Receives: Procedure: HIPEC; Drug: Carboplatin

What is being measured

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

  1. Elevation of side-effects and postoperative complication-rate

    Observation, classification and graduation of side-effects through NCI Common Terminology Criteria for Adverse Events version 4.03 ["safety issue"]

    Measured: 24 months

Secondary outcomes (2)

  1. Survey of quality of life per EORTC evaluated questionnaires

    Using EORTC -QLQ-C30 and EORTC QLQ-OV28, at study initiation, postoperative, before systemic chemotherapy and afterwards

    Measured: 24 months

  2. Recording of PFS (progession free survival)

    Recording of PFS (progession free survival) of the patients in a time-span of 24 months [kein "safety issue"]

    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 posted2 Jul 2015 (estimated)
  2. Study startAug 2016
  3. Primary completionAug 2016
  4. Study completionAug 2016

Why it stopped: actually limited personnel ressources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02487849
Sponsor's protocol ID
HIPEC-OVAR-REZIDIV-2014-1.1
Other IDs
2015-002436-41, 2015
Acronym
HIPEC
Status last verified
Mar 2020
First submitted
13 Jun 2015
Last updated
4 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HIPEC and Carboplatin in people with Epithelial Ovarian Cancer and Peritoneal Cancer, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.

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 21 inclusion and 19 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: withdrawn, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

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 was withdrawn before enrolling participants, so there are no results.

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?

Elevation of side-effects and postoperative complication-rate (time frame: 24 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 NCT02487849.

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 4 Mar 2020.

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