Peritoneal CancerIMMUNOPACNCT04122885
Study of Plasma Tumor-promoting Factors and Immune Function After Laparotomy, Cytoreductive Surgery and HIPEC vs. PIPAC in Patients With Peritoneal Metastasis
An observational study of Peritoneal Cancer and Chemotherapy-Induced Change, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The general goal of this study is to investigate the effect of treatment on serum concentrations of proteins known to impact angiogenesis or tumor growth and establishment in patients with peritoneal metastasis of various origin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Cancer, Chemotherapy-Induced Change
- What is being tested?
- PIPAC with oxaliplatin and Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2019to 30 Sep 2022
- 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: Subjects will be recruited from the institutions involved. All patients must meet inclusion/exclusion criteria (as indicated above) to be considered. Each subject will undergo medical examination during the screening visit (Visit 1) prior to enrolment. The personal data and detailed medical history will be recorded. The screening will take place no more than 6 weeks before intervention. This screening procedure will consist of: * Checking of inclusion/exclusion criteria * Detailed history including medical history * A standard physical examination including the cardiovascular, nervous, respiratory systems, conscience, memory, orientation, and body weight The patient's informed consent for study participation will be signed at the time of enrollment.
Who may be able to join
- Adult patients (18 years of age or older) with ovarian, gastric, or colorectal cancer who have PM who after thorough evaluation are deemed candidates for:
- CRS \& HIPEC if complete cytoreductive surgery is possible (OR)
- PIPAC if no complete cytoreductive surgery is possible at the University Hospital of Tubingen are eligible for entry in this study
Who cannot join
- ASA 3 \& 4 patients
- Patients who have received chemotherapy within 1 month prior to the planned surgery
- Patients who have received blood transfusion(s) within 2 weeks of the planned surgery
- Patients in whom the treatment plan includes systemic chemotherapy to be given during the first 2 weeks after surgery.
- History of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin
- Severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias
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- Immunocompromised patients such as those taking an immunosuppressive medication and those who have a known disease of the immune system
- Patients or family members involved in the planning and conduct of the study (applies to University of Tübingen staff involved)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tübingen
Tübingen, 72076
Verena Schlaich, +4970712986722, verena.schlaich@med.uni-tuebingen.de
Rami Archid, MD
About this study
Official title: Study of Plasma Tumor-promoting Factors and Immune Function After Explorative Laparotomy, Tumor Debulking and HIPEC (Hyperthermic Intraperitoneal Chemotherapy) vs. PIPAC (Pressurized IntraPeritoneal Aerosol Chemothereapy) in Patients With Peritoneal Metastasis as Evaluated by Serum Proliferative Activity, Levels of Proteins, Cytokines, Circulating Growth Factors, Inhibitors and Their Binding Proteins.
The general goal of this study is to investigate the effect of treatment on serum concentrations of proteins known to impact angiogenesis or tumor growth and establishment in patients with peritoneal metastasis of various origin. Since the immune system is thought, by many, to have an impact on tumor growth and development, this study also seeks to determine the impact of abdominal surgery on postoperative immune function in PM patients, as judged by proteins known to influence immune function. This study will not only characterize the postoperative plasma but also to determine if the magnitude of any of the changes noted is associated with a worse or improved oncologic outcome.
The principle purpose of this study is to gather perioperative serum/plasma samples from patients with PM from a variety of different primary tumors (ovarian, gastric, and colorectal) undergoing either CRS and HIPEC versus PIPAC.
Read the detailed description
The plasma samples obtained in this protocol will also be used to study the various plasma proteins that influence immune function as well as those that influence angiogenesis. In addition to the proteins mentioned above, there are also a large number of other proteins that have not been investigated thus far in the perioperative window; these proteins also merit assessment. The plasma obtained via this study and protocol will also be used to search for other tumor growth factors influenced by surgery or to investigate the impact of surgery on immune function.
Aim 1: To determine perioperative serum levels, over time, of a variety of serum proteins including but not limited to IGFBP-3, VEGF, Ang 2, PlGF, sVCAM, CHI3L1, MMP-2, MMP-3, MCP-1 and proteins that influence immune function as well as other proteins in the following 2 groups of patients:
- PM patients treated with CRS and HIPEC
- PM patients treated with PIPAC.
Aim 2: To compare the perioperative blood protein results between the 2 different groups of patients.
Aim 3: To determine, within each group, a possible correlation between the magnitude of these effects on oncological outcome (patient overall survival).
Aim 4: To search for other surgery-influenced plasma or cellular factors that may influence early postoperative tumor growth or that hold promise as tumor or prognostic markers.
- Conditions
- Peritoneal Cancer, Chemotherapy-Induced Change
- Being tested
- PIPAC with oxaliplatin, Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy
- Keywords
- HIPEC, PIPAC, cytoreductive surgery, immune function, cytokines, plasma proteins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPAC with oxaliplatinCombination product
Oxaliplatin 92 mg/m2 BSA, applied as an aerosol for 30 min under normothermic conditions at 12-15 mmHg pressure
Cytoreductive surgery and Hyperthermic IntraPeritoneal ChemotherapyProcedure or surgery
Also called CRS and HIPEC
If complete cytoreduction possible (CC-0). Application time 60 min, T 41-43 °C
| Study group | Role | What they receive |
|---|---|---|
| CRS and HIPEC | Cyroreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Receives: Procedure: Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy | |
| PIPAC | Pressurized IntraPeritoneal Aerosol Chemotherapy (if CRS and HIPEC not possible) Receives: Combination Product: PIPAC with oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of the proteins of interest over time
Measured: 6 weeks
Secondary outcomes (2)
Postoperative complications
Measured: 30 days
Overall survival
Measured from time point of intervention
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Oct 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Marc A Reymond, MD MBA, Principal investigator, National Center for Pleura and Peritoneum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122885
- Sponsor's protocol ID
- 392/2018BO1
- Acronym
- IMMUNOPAC
- Status last verified
- Oct 2019
- First submitted
- 9 Oct 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD might be shared on request after completion of the study
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Plasma Tumor-promoting Factors and Immune Function After Explorative Laparotomy, Tumor Debulking and HIPEC (Hyperthermic Intraperitoneal Chemotherapy) vs. PIPAC (Pressurized IntraPeritoneal Aerosol Chemothereapy) in Patients With Peritoneal Metastasis as Evaluated by Serum Proliferative Activity, Levels of Proteins, Cytokines, Circulating Growth Factors, Inhibitors and Their Binding Proteins.
- ClinicalTrials.gov ID
- NCT04122885
- Acronym / sponsor ID
- IMMUNOPAC / 392/2018BO1
- Conditions
- Peritoneal Cancer, Chemotherapy-Induced Change
- Keywords
- HIPEC, PIPAC, cytoreductive surgery, immune function, cytokines, plasma proteins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 10 Oct 2019 (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.
The general goal of this study is to investigate the effect of treatment on serum concentrations of proteins known to impact angiogenesis or tumor growth and establishment in patients with peritoneal metastasis of various origin. Since the immune system is thought, by many, to have an impact on tumor growth and development, this study also seeks to determine the impact of abdominal surgery on postoperative immune function in PM patients, as judged by proteins known to influence immune function. This study will not only characterize the postoperative plasma but also to determine if the magnitude of any of the changes noted is associated with a worse or improved oncologic outcome.
The principle purpose of this study is to gather perioperative serum/plasma samples from patients with PM from a variety of different primary tumors (ovarian, gastric, and colorectal) undergoing either CRS and HIPEC versus PIPAC.
Detailed description
The plasma samples obtained in this protocol will also be used to study the various plasma proteins that influence immune function as well as those that influence angiogenesis. In addition to the proteins mentioned above, there are also a large number of other proteins that have not been investigated thus far in the perioperative window; these proteins also merit assessment. The plasma obtained via this study and protocol will also be used to search for other tumor growth factors influenced by surgery or to investigate the impact of surgery on immune function.
Aim 1: To determine perioperative serum levels, over time, of a variety of serum proteins including but not limited to IGFBP-3, VEGF, Ang 2, PlGF, sVCAM, CHI3L1, MMP-2, MMP-3, MCP-1 and proteins that influence immune function as well as other proteins in the following 2 groups of patients:
- PM patients treated with CRS and HIPEC
- PM patients treated with PIPAC.
Aim 2: To compare the perioperative blood protein results between the 2 different groups of patients.
Aim 3: To determine, within each group, a possible correlation between the magnitude of these effects on oncological outcome (patient overall survival).
Aim 4: To search for other surgery-influenced plasma or cellular factors that may influence early postoperative tumor growth or that hold promise as tumor or prognostic markers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRS and HIPEC | – | Procedure: Cytoreductive surgery and Hyperthermic IntraPeritoneal ChemotherapyCyroreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) |
| PIPAC | – | Combination Product: PIPAC with oxaliplatinPressurized IntraPeritoneal Aerosol Chemotherapy (if CRS and HIPEC not possible) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the institutions involved. All patients must meet inclusion/exclusion criteria (as indicated above) to be considered. Each subject will undergo medical examination during the screening visit (Visit 1) prior to enrolment. The personal data and detailed medical history will be recorded. The screening will take place no more than 6 weeks before intervention. This screening procedure will consist of: * Checking of inclusion/exclusion criteria * Detailed history including medical history * A standard physical examination including the cardiovascular, nervous, respiratory systems, conscience, memory, orientation, and body weight The patient's informed consent for study participation will be signed at the time of enrollment.
Key inclusion criteria (3 listed)
- Adult patients (18 years of age or older) with ovarian, gastric, or colorectal cancer who have PM who after thorough evaluation are deemed candidates for:
- CRS \& HIPEC if complete cytoreductive surgery is possible (OR)
- PIPAC if no complete cytoreductive surgery is possible at the University Hospital of Tubingen are eligible for entry in this study
Key exclusion criteria (9 listed)
- ASA 3 \& 4 patients
- Patients who have received chemotherapy within 1 month prior to the planned surgery
- Patients who have received blood transfusion(s) within 2 weeks of the planned surgery
- Patients in whom the treatment plan includes systemic chemotherapy to be given during the first 2 weeks after surgery.
- History of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin
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 |
|---|---|---|
| PIPAC with oxaliplatinOxaliplatin 92 mg/m2 BSA, applied as an aerosol for 30 min under normothermic conditions at 12-15 mmHg pressure | Combination product | PIPAC |
| Cytoreductive surgery and Hyperthermic IntraPeritoneal ChemotherapyAlso: CRS and HIPECIf complete cytoreduction possible (CC-0). Application time 60 min, T 41-43 °C | Procedure or surgery | CRS and HIPEC |
Primary outcome
Serum levels of the proteins of interest over time
Time frame: 6 weeks
2 secondary outcomes
Postoperative complications
Time frame: 30 days
Overall survival
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- University Hospital TübingenLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. IPD might be shared on request after completion of the study
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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.
Marc A Reymond, MD MBA principal investigator
National Center for Pleura and Peritoneum
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 Cancer and Chemotherapy-Induced Change, run by University Hospital Tuebingen at 1 site in Germany.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Oct 2019. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc A Reymond, MD MBA (+4970712986722, marc.reymond@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of the proteins of interest over time (time frame: 6 weeks). 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 10 Oct 2019.