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

Primary Purpose

Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
HIPEC
Carboplatin
Sponsored by
Krankenhaus Barmherzige Schwestern Linz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIPEC

Arm Description

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

Outcomes

Primary Outcome Measures

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"]

Secondary Outcome Measures

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
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"]

Full Information

First Posted
June 13, 2015
Last Updated
March 2, 2020
Sponsor
Krankenhaus Barmherzige Schwestern Linz
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1. Study Identification

Unique Protocol Identification Number
NCT02487849
Brief Title
HIPEC After Secondary Cytoreductive Operation in Patients With Platinum-sensitive Recurrence of Ovarian Carcinoma
Acronym
HIPEC
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
actually limited personnel ressources
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krankenhaus Barmherzige Schwestern Linz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIPEC
Arm Type
Experimental
Arm Description
If patient is eligible - secondary cytoreductive operation will be followed by HIPEC with 800 mg/m² body surface (KOF) Carboplatin with closed technique.
Intervention Type
Procedure
Intervention Name(s)
HIPEC
Other Intervention Name(s)
Hyperthermal intraperitoneal Chemotherapy
Intervention Description
secondary cytoreductive operation
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Carboplatin Accord
Intervention Description
Hyperthermal Intraperitoneal Chemotherapy (HIPEC)
Primary Outcome Measure Information:
Title
Elevation of side-effects and postoperative complication-rate
Description
Observation, classification and graduation of side-effects through NCI Common Terminology Criteria for Adverse Events version 4.03 ["safety issue"]
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Survey of quality of life per EORTC evaluated questionnaires
Description
Using EORTC -QLQ-C30 and EORTC QLQ-OV28, at study initiation, postoperative, before systemic chemotherapy and afterwards
Time Frame
24 months
Title
Recording of PFS (progession free survival)
Description
Recording of PFS (progession free survival) of the patients in a time-span of 24 months [kein "safety issue"]
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukas Hefler, Prim. Dr.
Organizational Affiliation
Krankenhaus der Barmherzigen Schwestern Linz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of gynaecology, Ordensklinikum Linz Ges.m.b.H, Barmherzige Schwestern
City
Linz
ZIP/Postal Code
4010
Country
Austria

12. IPD Sharing Statement

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

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