Peritoneal CarcinomatosisPIPAC_01NCT03100708
Register Study of Patients With Peritoneal Carcinomatosis Treated With PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy)
An observational study of Peritoneal Carcinomatosis, run by University of Leipzig at 1 site in Germany.
Trial summary
The study will follow up patients with peritoneal carcinomatosis from colorectal, ovarian, gastric, pancreatic cancers and primary peritoneal tumors and undergoing a diagnostic laparoscopy / laparotomy, a PIPAC as single dose or repeated every 6 weeks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peritoneal Carcinomatosis
- What is being tested?
- PIPAC
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Apr 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients suffer from peritoneal carcinomatosis.
Who may be able to join
- Patient with clinical and pathological confirmed peritoneal carcinomatosis from gastric, colorectal, pancreatic, ovarian cancers or primary peritoneal tumors
- Age > 18 years
- signed informed consent
Who cannot join
- Patient can not understand meaning and purpose of the study
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Leipzig - AöR
Leipzig, Saxony, 04103
About this study
Official title: Evaluation of Molecular and Pathophysiological Mechanisms of Peritoneal Carcinomatosis and Monitoring of the Efficiency of PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy) as a Local Chemotherapeutical Treatment.
The study will follow up patients with peritoneal carcinomatosis from colorectal, ovarian, gastric, pancreatic cancers and primary peritoneal tumors and undergoing a diagnostic laparoscopy / laparotomy, a PIPAC as single dose or repeated every 6 weeks. The Overall Response Rate (ORR), the Overall Survival (OS) and the Quality of Life will be assessed before every PIPAC. Biopsies of the peritoneal carcinomatosis and blood (plasma and serum) are collected with every PIPAC intervention to follow up and to document the individual success or progress of the patients. The advice of the tumor board is mandatory to confirm the indication for local chemotherapy (PIPAC).
- Conditions
- Peritoneal Carcinomatosis
- Being tested
- PIPAC
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPACProcedure or surgery
Also called Pressurized Intra-peritoneal Aerosol-Chemotherapy
- Cisplatin 7.5 mg/m2 body surface in 150 ml NaCl 0,9% + Doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% in patients with ovarian, gastric, pancreatic cancer and in primary peritoneal tumors.
- Oxaliplatin 92 mg/m2 body surface in 150 ml dextrose solution in patients with colorectal cancer.
The chemotherapeutics will be admitted to the abdomen by a nebulizer at a pressure of 200 psi and 12 mmHG with 0.5 mL/sec. Afterwards the chemotherapeutics can react for 30min before the abdominal gas will be drained to the clinics filtering system.
| Study group | Role | What they receive |
|---|---|---|
| Patient with peritoneal carcinomatosis | Patient with peritoneal carcinomatosis and the Indication for local therapy. The Clinics tumor-board advice is needed. Receives: Procedure: PIPAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (years)
Measured: 5 years
Secondary outcomes (3)
The Peritoneal Carcinomatosis Index (PCI) before and after repeated PIPAC treatments
Measured: 25 weeks
Overall Response Rate (CT RESIST criteria)
Complete response
Measured: 5 years
Quality of lfe questionnaire (EORTC QLQ-C15-PAL)
Groenvold M et al. The development of the EORTC QLQ-C15-PAL: a shortened questionnaire for cancer patients in palliative care. European Journal of Cancer 2006; 42(1): 55-64
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startApr 2016
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Boris Jansen-Winkeln, University of Leipzig
- Investigators
- Ines Gockel, Prof. Dr., Principal investigator, Universitätsklinikum Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100708
- Sponsor's protocol ID
- PIPAC_01
- Acronym
- PIPAC_01
- Status last verified
- Sep 2019
- First submitted
- 15 Nov 2016
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jansen-Winkeln B, Eberth J, Moulla Y, Mehdorn M, Niebisch S, Schierle K, Blaker H, Lordick F, Gockel I, Thieme R. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with peritoneal surface malignancies (PSM): a prospective single-center registry study. J Cancer Res Clin Oncol. 2023 Mar;149(3):1331-1341. doi: 10.1007/s00432-022-04517-w. Epub 2022 Dec 13.
PubMed 36513815Gockel I, Jansen-Winkeln B, Haase L, Niebisch S, Moulla Y, Lyros O, Lordick F, Schierle K, Wittekind C, Thieme R. Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in patients with peritoneal metastasized colorectal, appendiceal and small bowel cancer. Tumori. 2020 Feb;106(1):70-78. doi: 10.1177/0300891619868013. Epub 2019 Aug 30.
PubMed 31469058Gockel I, Jansen-Winkeln B, Haase L, Rhode P, Mehdorn M, Niebisch S, Moulla Y, Lyros O, Lordick F, Schierle K, Wittekind C, Thieme R. Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Cancer Patients with Peritoneal Metastasis (PM): Results of a Single-Center Experience and Register Study. J Gastric Cancer. 2018 Dec;18(4):379-391. doi: 10.5230/jgc.2018.18.e37. Epub 2018 Dec 14.
PubMed 30607301
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Molecular and Pathophysiological Mechanisms of Peritoneal Carcinomatosis and Monitoring of the Efficiency of PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy) as a Local Chemotherapeutical Treatment.
- ClinicalTrials.gov ID
- NCT03100708
- Acronym / sponsor ID
- PIPAC_01 / PIPAC_01
- Conditions
- Peritoneal Carcinomatosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 4 Apr 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.
The study will follow up patients with peritoneal carcinomatosis from colorectal, ovarian, gastric, pancreatic cancers and primary peritoneal tumors and undergoing a diagnostic laparoscopy / laparotomy, a PIPAC as single dose or repeated every 6 weeks. The Overall Response Rate (ORR), the Overall Survival (OS) and the Quality of Life will be assessed before every PIPAC. Biopsies of the peritoneal carcinomatosis and blood (plasma and serum) are collected with every PIPAC intervention to follow up and to document the individual success or progress of the patients. The advice of the tumor board is mandatory to confirm the indication for local chemotherapy (PIPAC).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with peritoneal carcinomatosis | – | Procedure: PIPACPatient with peritoneal carcinomatosis and the Indication for local therapy. The Clinics tumor-board advice is needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffer from peritoneal carcinomatosis.
Key inclusion criteria (3 listed)
- Patient with clinical and pathological confirmed peritoneal carcinomatosis from gastric, colorectal, pancreatic, ovarian cancers or primary peritoneal tumors
- Age > 18 years
- signed informed consent
Key exclusion criteria (1 listed)
- Patient can not understand meaning and purpose of 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 |
|---|---|---|
| PIPACAlso: Pressurized Intra-peritoneal Aerosol-Chemotherapy* Cisplatin 7.5 mg/m2 body surface in 150 ml NaCl 0,9% + Doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% in patients with ovarian, gastric, pancreatic cancer and in primary peritoneal tumors. * Oxaliplatin 92 mg/m2 body surface in 150 ml dextrose solution in patients with colorectal cancer. The chemotherapeutics will be admitted to the abdomen by a nebulizer at a pressure of 200 psi and 12 mmHG with 0.5 mL/sec. Afterwards the chemotherapeutics can react for 30min before the abdominal gas will be drained to the clinics filtering system. | Procedure or surgery | Patient with peritoneal carcinomatosis |
Primary outcome
Overall Survival (years)
Time frame: 5 years
3 secondary outcomes
The Peritoneal Carcinomatosis Index (PCI) before and after repeated PIPAC treatments
Time frame: 25 weeks
Overall Response Rate (CT RESIST criteria)
Time frame: 5 years
Quality of lfe questionnaire (EORTC QLQ-C15-PAL)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 36513815Jansen-Winkeln B, Eberth J, Moulla Y, Mehdorn M, Niebisch S, Schierle K, Blaker H, Lordick F, Gockel I, Thieme R. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with peritoneal surface malignancies (PSM): a prospective single-center registry study. J Cancer Res Clin Oncol. 2023 Mar;149(3):1331-1341. doi: 10.1007/s00432-022-04517-w. Epub 2022 Dec 13.
- Derived from this study: PubMed 31469058Gockel I, Jansen-Winkeln B, Haase L, Niebisch S, Moulla Y, Lyros O, Lordick F, Schierle K, Wittekind C, Thieme R. Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in patients with peritoneal metastasized colorectal, appendiceal and small bowel cancer. Tumori. 2020 Feb;106(1):70-78. doi: 10.1177/0300891619868013. Epub 2019 Aug 30.
- Derived from this study: PubMed 30607301Gockel I, Jansen-Winkeln B, Haase L, Rhode P, Mehdorn M, Niebisch S, Moulla Y, Lyros O, Lordick F, Schierle K, Wittekind C, Thieme R. Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Cancer Patients with Peritoneal Metastasis (PM): Results of a Single-Center Experience and Register Study. J Gastric Cancer. 2018 Dec;18(4):379-391. doi: 10.5230/jgc.2018.18.e37. Epub 2018 Dec 14.
- 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.
Ines Gockel, Prof. Dr. principal investigator
Universitätsklinikum Leipzig
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 University of Leipzig 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 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: status not confirmed, as of the sponsor's last update on 25 Sep 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 Ines Gockel, Prof. Dr. (+49 341 97 17200, ines.gockel@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (years) (time frame: 5 years). 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 NCT03100708, which also lists 3 linked publications.
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 25 Sep 2019.