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Trial record 14 of 141 for:    appendix cancer

Treating Peritoneal Carcinomatosis With PIPAC

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ClinicalTrials.gov Identifier: NCT02320448
Recruitment Status : Completed
First Posted : December 19, 2014
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Bau Mortensen, Odense University Hospital

Brief Summary:
This is a feasibility study that aims to evaluate whether PIPAC (Pressurized Intraperitoneal Aerosol Chemotherapy) is a safe and feasible treatment in Danish patients with peritoneal cancer.

Condition or disease Intervention/treatment Phase
Peritoneal Carcinomatosis Drug: PIPAC Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementation and Evaluation of PIPAC for the Treatment of Patients With Peritoneal Carcinomatosis - a Feasibility Study.
Actual Study Start Date : March 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Arm Intervention/treatment
Experimental: PIPAC

PIPAC with cisplatin (7.5mg/m2 in 150 ml saline) and doxorubicin (1.5mg/m2 in 50 ml saline) in patients with peritoneal metastases (PM) from any origin besides colorectal/appendiceal cancers in whom oxaliplatin (92mg/m2 in 150 ml dextrose) will be used.

The aerosolised chemotherapy will be nebulized at a flow of 0.5ml/min at a maximum pressure of 200 PSI during a standard laparoscopy with an intraabdominal pressure of 12mmHg. The CO2 will be evacuated 30 minutes after administration of chemotherapy and the patient is closed similar to a standard laparoscopy.

Drug: PIPAC
Other Names:
  • Cisplatin
  • Doxorubicin
  • Oxaliplatin




Primary Outcome Measures :
  1. Number of Patients with Adverse Events. [ Time Frame: 5 months. ]
    No patients with adverse events above grade 3 on the CTCAE (Version 4) scale. No patients with complications above grade 2 on the Dindo-Clavien classification.


Secondary Outcome Measures :
  1. Occupational health. [ Time Frame: 5 months. ]
    No detectable chemotherapy on environmental biomonitoring and blood samples from the surgeons and OR staff.

  2. Feasibility: Completion of procedure in 28:35 [ Time Frame: 5 months. ]
    Completion of procedure in 28:35.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Histological or cytological verified malignancy.
  • Clinical or radiological evidence of peritoneal carcinomatosis.
  • No indication for standard chemotherapy.
  • Performance status 0-2 and life expectancy of more than 3 months.
  • Age > 18 years.
  • Written informed consent must be obtained according to the local Ethics Committee requirements.

Exclusion criteria

  • Symptomatic small bowel obstruction (Total parenteral nutrition, nasogastric tube).
  • Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones.
  • A history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin.
  • Renal impairment, defined as GFR < 50 ml/min, (Cockcroft-Gault Equation).
  • Myocardial insufficiency, defined as NYHA class > 2.
  • Impaired liver function defined as bilirubin ≥ 1,5 x UNL (upper normal limit).
  • Inadequate haematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l.
  • Any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.
  • Previous intraabdominal chemotherapy or intraabdominal antibody therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320448


Locations
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Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Michael Bau Mortensen
Investigators
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Study Director: Michael Mortensen, Professor Odense University Hospital

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Bau Mortensen, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02320448     History of Changes
Other Study ID Numbers: PIPAC
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Carcinoma
Digestive System Diseases
Peritoneal Diseases
Cisplatin
Oxaliplatin
Doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action