Trial record 4 of 50 for:    ovarian cancer recurrence | Open Studies | Exclude Unknown

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2015 by Krankenhaus Barmherzige Schwestern Linz
Sponsor:
Information provided by (Responsible Party):
Krankenhaus Barmherzige Schwestern Linz
ClinicalTrials.gov Identifier:
NCT02487849
First received: June 13, 2015
Last updated: June 29, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Epithelial Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Procedure: HIPEC
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Krankenhaus Barmherzige Schwestern Linz:

Primary Outcome Measures:
  • Elevation of side-effects and postoperative complication-rate [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Observation, classification and graduation of side-effects through NCI Common Terminology Criteria for Adverse Events version 4.03 ["safety issue"]


Secondary Outcome Measures:
  • Survey of quality of life per EORTC evaluated questionnaires [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Using EORTC -QLQ-C30 and EORTC QLQ-OV28, at study initiation, postoperative, before systemic chemotherapy and afterwards

  • Recording of PFS (progession free survival) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Recording of PFS (progession free survival) of the patients in a time-span of 24 months [kein "safety issue"]


Estimated Enrollment: 10
Study Start Date: November 2015
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIPEC
If patient is eligible - secondary cytoreductive operation will be followed by HIPEC with 800 mg/m² body surface (KOF) Carboplatin with closed technique.
Procedure: HIPEC
secondary cytoreductive operation
Other Name: Hyperthermal intraperitoneal Chemotherapy
Drug: Carboplatin
Hyperthermal Intraperitoneal Chemotherapy (HIPEC)
Other Name: Carboplatin Accord

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02487849

Contacts
Contact: Verena Unterrichter, Dr. +43 732 7677 ext 4681 verena.unterrichter@bhs.at
Contact: Carina Allerstorfer, BSc. +43 732 7677 ext 4296 carina.allerstorfer@bhs.at

Sponsors and Collaborators
Krankenhaus Barmherzige Schwestern Linz
Investigators
Principal Investigator: Lukas Hefler, Prim. Dr. Krankenhaus der Barmherzigen Schwestern Linz
  More Information

Responsible Party: Krankenhaus Barmherzige Schwestern Linz
ClinicalTrials.gov Identifier: NCT02487849     History of Changes
Other Study ID Numbers: HIPEC-OVAR-REZIDIV-2014-1.1  2015-002436-41 
Study First Received: June 13, 2015
Last Updated: June 29, 2015
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Recurrence
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Disease Attributes
Pathologic Processes
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 24, 2016