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Clinical Pharmacology of Platinum-based Hyperthermic Intraperitoneal Chemotherapy (GUTOX)

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ClinicalTrials.gov Identifier: NCT03364907
Recruitment Status : Active, not recruiting
First Posted : December 7, 2017
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:
Currently, there is a lack of knowledge on the effect of additional flushing after HIPEC on tumour platinum exposure, systemic platinum exposure and platinum concentration in drain exudate and thereby personal exposure. Therefore the investigators want to perform a study to investigate the effect of flushing after HIPEC on tumour exposure, systemic exposure and on wound exudate concentration.

Condition or disease Intervention/treatment
Peritoneal Carcinomatosis Other: HIPEC with flushing afterwards Other: HIPEC without flushing afterwards

Detailed Description:
Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) is standard care in the treatment of patients with peritoneal carcinomatosis as a result of intra-abdominal cancers. In many (inter)national centres oxaliplatin is used for the primary HIPEC treatment. Although the oxaliplatin dose of 460mg/m2 is widely accepted, the exact procedure of HIPEC differs between institutions and surgeons. Due to a great variety in the volume of the abdominal cavity, platinum concentration in the perfusate might differ between patients. Moreover, there is no consensus about the usefulness of flushing the HIPEC system with crystalloids at the end of oxaliplatin administration. Flushing is predominantly performed with the idea to minimize both systemic exposure of ultrafilterable platinum and personnel exposure to platinum contaminated exudate. On the other hand, HIPEC without flushing might increase effectiveness because intraperitoneal tumour cells are exposed to high concentrations of oxaliplatin for a longer time period. The option of flushing is based on an individual preference of the surgeon. Currently, there is a lack of knowledge on the effect of flushing on tumour platinum exposure, systemic platinum exposure and platinum concentration in drain exudate and thereby personal exposure. Therefore the investigators want to perform a study to investigate the effect of flushing after HIPEC on tumour exposure, systemic exposure and on wound exudate concentration.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical pharmacoloGy of platinUm-based hyperThermic Intraperitoneal Chemotherapy: Exploration of the Impact of Flushing on tumOur, Systemic and Personnel eXposure (GUTOX)
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : June 8, 2019
Estimated Study Completion Date : December 30, 2019

Group/Cohort Intervention/treatment
HIPEC patients
Patients with a diagnosis of peritoneal carcinomatosis who undergo HIPEC treatment with oxaliplatin.
Other: HIPEC with flushing afterwards
flushing with saline fluid after HIPEC

Other: HIPEC without flushing afterwards
NO flushing with saline fluid after HIPEC




Primary Outcome Measures :
  1. change in tissue platinum exposure before and after flushing [ Time Frame: immediately after the oxaliplatin instillate solution is withdrawn from the abdominal cavity and immediately after additional flushing is performed. This takes all place within 1 hour after the start of HIPEC. ]
    Change in tissue platinum exposure of non-tumour peritoneal tissue sample before and after flushing with saline


Secondary Outcome Measures :
  1. wound exudate platinum concentration [ Time Frame: until day 3 post-HIPEC ]
    platinum concentration in wound exudate samples will be measured in the drains

  2. systemic exposure of total and unbound platinum [ Time Frame: until day 3 post-HIPEC ]
    systemic exposure of total and unbound platinum will be measured using 13 blood samples

  3. total and unbound platinum concentration in instillate [ Time Frame: all samples will be taken within 30 minutes during the HIPEC procedure ]
    total and unbound platinum concentration in instillate will be measured in 3 samples of instillate solution that will be obtained during the HIPEC procedure


Biospecimen Retention:   Samples Without DNA
peritoneal tissue samples, blood samples, instillate samples and wound exudate samples will be collected from the patients


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with peritoneal carcinomatosis who undergo HIPEC treatment with oxaliplatin as part of routine care.
Criteria

Inclusion Criteria:

  1. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.

    Note: Informed consent may be obtained prior to start of the specified screening window.

    Note: Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes.

  2. Age ≥ 18 years
  3. Confirmed diagnosis of preoperatively identifi ed primary or recurrent peritoneal carcinomatosis (PC) of colorectal origin who are planned for HIPEC treatment with oxaliplatin according to routine clinical care

Exclusion Criteria:

1) Patients who do not achieve a cytoreduction score of CC-0 will be excluded from the study.


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): NCT03364907


Locations
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Netherlands
Radboudumc
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
  Study Documents (Full-Text)

Documents provided by Radboud University:
Study Protocol  [PDF] November 16, 2017


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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03364907     History of Changes
Other Study ID Numbers: GUTOX
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Radboud University:
HIPEC
oxaliplatin
flushing
peritoneal carcinomatosis

Additional relevant MeSH terms:
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Carcinoma
Fever
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Body Temperature Changes
Signs and Symptoms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases