NCT02487849

Brief 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. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

Same day

First QC Date

June 13, 2015

Last Update Submit

March 2, 2020

Conditions

Epithelial Ovarian CancerPeritoneal CancerFallopian Tube Cancer

Outcome Measures

Primary Outcomes (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 \["safety issue"\]

    24 months

Secondary Outcomes (2)

  • Survey of quality of life per EORTC evaluated questionnaires

    24 months

  • Recording of PFS (progession free survival)

    24 months

Study Arms (1)

HIPEC

EXPERIMENTAL

If patient is eligible - secondary cytoreductive operation will be followed by HIPEC with 800 mg/m² body surface (KOF) Carboplatin with closed technique.

Procedure: HIPECDrug: Carboplatin

Interventions

HIPECPROCEDURE

secondary cytoreductive operation

Also known as: Hyperthermal intraperitoneal Chemotherapy
HIPEC
CarboplatinDRUG

Hyperthermal Intraperitoneal Chemotherapy (HIPEC)

Also known as: Carboplatin Accord
HIPEC

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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
  • 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
  • +6 more criteria

You may not qualify if:

  • 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
  • acute infectious disease with need for intravenous antibiosis
  • immunodeficiency
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Linz, 4010, Austria

Location

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube Neoplasms

Interventions

Hyperthermic Intraperitoneal ChemotherapyCarboplatin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, InducedCoordination ComplexesOrganic Chemicals

Study Officials

  • Lukas Hefler, Prim. Dr.

    Krankenhaus der Barmherzigen Schwestern Linz

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2015

First Posted

July 2, 2015

Study Start

August 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

AU(1)