Peritoneal CarcinomatosisGUTOXNCT03364907
Clinical Pharmacology of Platinum-based Hyperthermic Intraperitoneal Chemotherapy
An observational study of Peritoneal Carcinomatosis, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Carcinomatosis
- What is being tested?
- HIPEC with flushing afterwards and HIPEC without flushing afterwards
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2018to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with peritoneal carcinomatosis who undergo HIPEC treatment with oxaliplatin as part of routine care.
Who may be able to join
- 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.
- Age ≥ 18 years
- 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
Who cannot join
- 1) Patients who do not achieve a cytoreduction score of CC-0 will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical pharmacoloGy of platinUm-based hyperThermic Intraperitoneal Chemotherapy: Exploration of the Impact of Flushing on tumOur, Systemic and Personnel eXposure (GUTOX)
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.
Read the 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.
- Conditions
- Peritoneal Carcinomatosis
- Being tested
- HIPEC with flushing afterwards, HIPEC without flushing afterwards
- Keywords
- HIPEC, oxaliplatin, flushing, peritoneal carcinomatosis
- Medical subject headings
- Peritoneal Neoplasms, Flushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPEC with flushing afterwardsOther
flushing with saline fluid after HIPEC
HIPEC without flushing afterwardsOther
NO flushing with saline fluid after HIPEC
| Study group | Role | What they receive |
|---|---|---|
| HIPEC patients | Patients with a diagnosis of peritoneal carcinomatosis who undergo HIPEC treatment with oxaliplatin. Receives: Other: HIPEC with flushing afterwards; Other: HIPEC without flushing afterwards |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in tissue platinum exposure before and after flushing
Change in tissue platinum exposure of non-tumour peritoneal tissue sample before and after flushing with saline
Measured: 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.
Secondary outcomes (3)
wound exudate platinum concentration
platinum concentration in wound exudate samples will be measured in the drains
Measured: until day 3 post-HIPEC
systemic exposure of total and unbound platinum
systemic exposure of total and unbound platinum will be measured using 13 blood samples
Measured: until day 3 post-HIPEC
total and unbound platinum concentration in instillate
total and unbound platinum concentration in instillate will be measured in 3 samples of instillate solution that will be obtained during the HIPEC procedure
Measured: all samples will be taken within 30 minutes during the HIPEC procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Mar 2018
- Primary completion8 Jun 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364907
- Sponsor's protocol ID
- GUTOX
- Acronym
- GUTOX
- Status last verified
- Jul 2020
- First submitted
- 2 Oct 2017
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Jong LAW, Elekonawo FMK, Lambert M, de Gooyer JM, Verheul HMW, Burger DM, de Wilt JHW, Chatelut E, Ter Heine R, de Reuver PR, Bremers AJA, van Erp NP. Wide variation in tissue, systemic, and drain fluid exposure after oxaliplatin-based HIPEC: results of the GUTOX study. Cancer Chemother Pharmacol. 2020 Jul;86(1):141-150. doi: 10.1007/s00280-020-04107-y. Epub 2020 Jun 27.
PubMed 32594200
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical pharmacoloGy of platinUm-based hyperThermic Intraperitoneal Chemotherapy: Exploration of the Impact of Flushing on tumOur, Systemic and Personnel eXposure (GUTOX)
- ClinicalTrials.gov ID
- NCT03364907
- Acronym / sponsor ID
- GUTOX / GUTOX
- Conditions
- Peritoneal Carcinomatosis
- Keywords
- HIPEC, oxaliplatin, flushing, peritoneal carcinomatosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 8 Jun 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIPEC patients | – | Other: HIPEC with flushing afterwards, Other: HIPEC without flushing afterwardsPatients with a diagnosis of peritoneal carcinomatosis who undergo HIPEC treatment with oxaliplatin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with peritoneal carcinomatosis who undergo HIPEC treatment with oxaliplatin as part of routine care.
Key inclusion criteria (5 listed)
- 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.
- Age ≥ 18 years
- 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
Key exclusion criteria (1 listed)
- 1) Patients who do not achieve a cytoreduction score of CC-0 will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIPEC with flushing afterwardsflushing with saline fluid after HIPEC | Other | HIPEC patients |
| HIPEC without flushing afterwardsNO flushing with saline fluid after HIPEC | Other | HIPEC patients |
Primary outcome
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
3 secondary outcomes
wound exudate platinum concentration
Time frame: until day 3 post-HIPEC
systemic exposure of total and unbound platinum
Time frame: until day 3 post-HIPEC
total and unbound platinum concentration in instillate
Time frame: all samples will be taken within 30 minutes during the HIPEC procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Results publication: PubMed 32594200de Jong LAW, Elekonawo FMK, Lambert M, de Gooyer JM, Verheul HMW, Burger DM, de Wilt JHW, Chatelut E, Ter Heine R, de Reuver PR, Bremers AJA, van Erp NP. Wide variation in tissue, systemic, and drain fluid exposure after oxaliplatin-based HIPEC: results of the GUTOX study. Cancer Chemother Pharmacol. 2020 Jul;86(1):141-150. doi: 10.1007/s00280-020-04107-y. Epub 2020 Jun 27.
- paperLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Carcinomatosis, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03364907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.