Brief Title
HIPEC After Secondary Cytoreductive Operation in Patients With Platinum-sensitive Recurrence of Ovarian Carcinoma
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
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.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Elevation of side-effects and postoperative complication-rate
Secondary Outcome
Survey of quality of life per EORTC evaluated questionnaires
Condition
Epithelial Ovarian Cancer
Intervention
HIPEC
Study Arms / Comparison Groups
HIPEC
Description: If patient is eligible - secondary cytoreductive operation will be followed by HIPEC with 800 mg/m² body surface (KOF) Carboplatin with closed technique.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
0
Start Date
August 2016
Completion Date
August 2016
Primary Completion Date
August 2016
Eligibility Criteria
Inclusion Criteria:
- ≥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
- 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
Exclusion Criteria:
- 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
- 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Lukas Hefler, Prim. Dr., ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT02487849
Organization ID
HIPEC-OVAR-REZIDIV-2014-1.1
Secondary IDs
2015-002436-41
Responsible Party
Sponsor
Study Sponsor
Krankenhaus Barmherzige Schwestern Linz
Study Sponsor
Lukas Hefler, Prim. Dr., Principal Investigator, Krankenhaus der Barmherzigen Schwestern Linz
Verification Date
March 2020