Peritoneal CarcinomatosisPhase 2NCT01575730
Cytoreduction Followed by Normothermic Versus Hyperthermic Intraperitoneal Intraoperative Chemoperfusion (HIPEC): a Study in Peritoneal Carcinomatosis
A Phase 2 study testing Hyperthermic intraoperative Peritoneal Chemoperfusion in people with Peritoneal Carcinomatosis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Peritoneal carcinomatosis from appendix or colon (large bowel) cancer is treated in suitable patients with surgery followed by instillation of heated chemotherapy inside the abdominal cavity. This procedure is termed 'Hyperthermic intraoperative Peritoneal Chemoperfusion' or HIPEC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Carcinomatosis
- What is being tested?
- Hyperthermic intraoperative Peritoneal Chemoperfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- 21 May 2012to 18 Mar 2013
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with peritoneal carcinomatosis from colorectal origin (including appendiceal mucinous neoplasms and the pseudomyxoma syndromes) amenable for cytoreduction and HIPEC.
Who cannot join
- No written informed consent
- Irresectable and/or metastatic disease found during surgery
- Known allergy to oxaliplatin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study Comparing Normothermic Versus Hyperthermic Intraoperative Chemoperfusion With Oxaliplatin in Patients With Peritoneal Metastases From Appendiceal or Colon Cancer
Peritoneal carcinomatosis from appendix or colon (large bowel) cancer is treated in suitable patients with surgery followed by instillation of heated chemotherapy inside the abdominal cavity. This procedure is termed 'Hyperthermic intraoperative Peritoneal Chemoperfusion' or HIPEC. Many center perform HIPEC with high dose oxaliplatin, a standard chemotherapy drug active against colon cancer, administered during 30 minutes at 41°C. The hypothesis of this study is, that chemoperfusion at normal (37.5°C) temperature but longer duration (90 minutes) may be safer and at least as efficient. Patients will be treated with one of three possible HIPEC regimens using oxaliplatin: high dose, 30 min, 41°C; high dose, 30 min, 37.5°C; or low dose, 90 min, 37.5°C. The outcome parameters are pharmacokinetic and pharmacodynamic: using specialized techniques, tissue penetration of chemotherapy and cancer cell kill effects will be compared in order to establish the safest and most active HIPEC regimen.
- Conditions
- Peritoneal Carcinomatosis
- Being tested
- Hyperthermic intraoperative Peritoneal Chemoperfusion
- Keywords
- Peritoneal carcinomatosis from colorectal or appendiceal origin
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermic intraoperative Peritoneal ChemoperfusionProcedure or surgery
Dose: 460 mg/m², duration: 30 minutes, temperature 37°C
Hyperthermic intraoperative Peritoneal ChemoperfusionProcedure or surgery
Dose: 460 mg/m², duration: 30 minutes, temperature 41°C
Hyperthermic intraoperative Peritoneal ChemoperfusionDrug
Dose: 200 mg/m², duration: 90 minutes, temperature 37°C
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin 37°C, high dose, 30 minutes | Active comparator | Not described Receives: Procedure: Hyperthermic intraoperative Peritoneal Chemoperfusion |
| Oxaliplatin 41 °C, high dose, 30 minutes | Placebo comparator | Not described Receives: Procedure: Hyperthermic intraoperative Peritoneal Chemoperfusion |
| Oxaliplatin 37°C, low dose, 90 minutes | Active comparator | Not described Receives: Drug: Hyperthermic intraoperative Peritoneal Chemoperfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Scoring of postoperative morbidity according to the Dindo-Clavien system
Measured: Until discharge or within 30 days
Mortality
The number of deaths will be recorded.
Measured: Until discharge or within 30 days
Area under the perfusate concentration versus time curve (AUC) of platinum
Measurements of platinum in perfusate samples on the high dose interventions.
Measured: Before addition of chemotherapy, at 10, 20 and 30 minutes after addition of chemotherapy
Area under the perfusate concentration versus time curve (AUC) of platinum
Measurements of platinum in perfusate samples on the low dose intervention.
Measured: Before addition of chemotherapy, at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after addition of chemotherapy
Area under the plasma concentration versus time curve (AUC) of platinum
Measurements of platinum in perfusate samples on the high dose interventions.
Measured: Before addition of chemotherapy, at 10, 20, 30,45, 60, 90 minutes and 2, 4, 8, 12, 18, 24 hours after addition of chemotherapy
Area under the plasma concentration versus time curve (AUC) of platinum
Measurements of platinum in plasma samples on the low dose intervention.
Measured: Before addition of chemotherapy, at 10, 20, 30, 40, 50, 60, 70, 80, 90 minutes and 2, 4, 8, 12, 18, 24 hours after addition of chemotherapy
Secondary outcomes (1)
Tissue Concentration (Cmax) of Platinum
Platinum concentration will be measured after removal of perfusate.
Measured: after 30 or 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study start21 May 2012
- Primary completion18 Mar 2013
- Study completion18 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Wim P Ceelen, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575730
- Sponsor's protocol ID
- 2012/237
- Other IDs
- 2012-000701-77
- Status last verified
- Dec 2022
- First submitted
- 6 Apr 2012
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Comparing Normothermic Versus Hyperthermic Intraoperative Chemoperfusion With Oxaliplatin in Patients With Peritoneal Metastases From Appendiceal or Colon Cancer
- ClinicalTrials.gov ID
- NCT01575730
- Acronym / sponsor ID
- 2012/237
- Conditions
- Peritoneal Carcinomatosis
- Keywords
- Peritoneal carcinomatosis from colorectal or appendiceal origin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 21 May 2012 (actual)
- Primary completion
- 18 Mar 2013 (actual)
- Study completion
- 18 Mar 2013 (actual)
- First posted
- 11 Apr 2012 (estimated)
- 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.
Peritoneal carcinomatosis from appendix or colon (large bowel) cancer is treated in suitable patients with surgery followed by instillation of heated chemotherapy inside the abdominal cavity. This procedure is termed 'Hyperthermic intraoperative Peritoneal Chemoperfusion' or HIPEC. Many center perform HIPEC with high dose oxaliplatin, a standard chemotherapy drug active against colon cancer, administered during 30 minutes at 41°C. The hypothesis of this study is, that chemoperfusion at normal (37.5°C) temperature but longer duration (90 minutes) may be safer and at least as efficient. Patients will be treated with one of three possible HIPEC regimens using oxaliplatin: high dose, 30 min, 41°C; high dose, 30 min, 37.5°C; or low dose, 90 min, 37.5°C. The outcome parameters are pharmacokinetic and pharmacodynamic: using specialized techniques, tissue penetration of chemotherapy and cancer cell kill effects will be compared in order to establish the safest and most active HIPEC regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin 37°C, high dose, 30 minutes | Active comparator | Procedure: Hyperthermic intraoperative Peritoneal Chemoperfusion |
| Oxaliplatin 41 °C, high dose, 30 minutes | Placebo comparator | Procedure: Hyperthermic intraoperative Peritoneal Chemoperfusion |
| Oxaliplatin 37°C, low dose, 90 minutes | Active comparator | Drug: Hyperthermic intraoperative Peritoneal Chemoperfusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with peritoneal carcinomatosis from colorectal origin (including appendiceal mucinous neoplasms and the pseudomyxoma syndromes) amenable for cytoreduction and HIPEC.
Key exclusion criteria (3 listed)
- No written informed consent
- Irresectable and/or metastatic disease found during surgery
- Known allergy to oxaliplatin
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 |
|---|---|---|
| Hyperthermic intraoperative Peritoneal ChemoperfusionDose: 460 mg/m², duration: 30 minutes, temperature 37°C | Procedure or surgery | Oxaliplatin 37°C, high dose, 30 minutes |
| Hyperthermic intraoperative Peritoneal ChemoperfusionDose: 460 mg/m², duration: 30 minutes, temperature 41°C | Procedure or surgery | Oxaliplatin 41 °C, high dose, 30 minutes |
| Hyperthermic intraoperative Peritoneal ChemoperfusionDose: 200 mg/m², duration: 90 minutes, temperature 37°C | Drug | Oxaliplatin 37°C, low dose, 90 minutes |
Primary outcome
Morbidity
Time frame: Until discharge or within 30 days
Scoring of postoperative morbidity according to the Dindo-Clavien system
Mortality
Time frame: Until discharge or within 30 days
The number of deaths will be recorded.
Area under the perfusate concentration versus time curve (AUC) of platinum
Time frame: Before addition of chemotherapy, at 10, 20 and 30 minutes after addition of chemotherapy
Measurements of platinum in perfusate samples on the high dose interventions.
Area under the perfusate concentration versus time curve (AUC) of platinum
Time frame: Before addition of chemotherapy, at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after addition of chemotherapy
Measurements of platinum in perfusate samples on the low dose intervention.
Area under the plasma concentration versus time curve (AUC) of platinum
Time frame: Before addition of chemotherapy, at 10, 20, 30,45, 60, 90 minutes and 2, 4, 8, 12, 18, 24 hours after addition of chemotherapy
Measurements of platinum in perfusate samples on the high dose interventions.
Area under the plasma concentration versus time curve (AUC) of platinum
Time frame: Before addition of chemotherapy, at 10, 20, 30, 40, 50, 60, 70, 80, 90 minutes and 2, 4, 8, 12, 18, 24 hours after addition of chemotherapy
Measurements of platinum in plasma samples on the low dose intervention.
1 secondary outcome
Tissue Concentration (Cmax) of Platinum
Time frame: after 30 or 90 minutes
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 15 Dec 2022.
- Related InfoLink provided by the sponsor.
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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.
Wim P Ceelen, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperthermic intraoperative Peritoneal Chemoperfusion in people with Peritoneal Carcinomatosis, run by University Hospital, Ghent at 1 site in Belgium.
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 1 inclusion and 3 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 15 Dec 2022. 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 Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Morbidity (time frame: Until discharge or within 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2022.