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Peritoneum CancerPIPACRegisNCT03210298

International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)

An observational study of Peritoneum Cancer and Peritoneum Neoplasm, run by Sabine Rhode at 16 sites in 13 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Multicentric, international, web-based prospective documentation of the indications and results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant pleural and peritoneal diseases. Indication is decided by the treating physician. There are no predefined inclusion or exclusion criteria. Read more about this study

Who is it for?
Ages 10 years and older
What is being tested?
PIPAC
How many people
1,000 participants
Where
16 sitesin 13 countries
Study dates
Jan 2016to Sep 2022
How long will I take part?
1 Year
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 10 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: In the rule, pretreated patients with chemoresistant peritoneal metastasis of various origins.

Who may be able to join

  • verified peritoneal metastasis
  • colorectal cancer
  • ovarian cancer
  • gastric cancer
  • appendical cancer
  • pseudomyxoma peritonei
Show all 10Show fewer
  • malignant mesothelioma
  • pancreatic cancer
  • gallbladder cancer
  • small bowel cancer

Who cannot join

  • bowel obstruction

Trial locations and contacts

16 sites in 13 countries.

Sabine Rhode contact

+49 391 67 17960

sabine.rhode@med.ovgu.de

16 sites in 13 countries

France4 sites, 4 recruiting

  • Centre Hospitalier Universitaire

    Grenoble

    Catherine Arvieux, MD, carvieux@chu-grenoble.fr

    Recruiting

  • Centre Hospitalier Universitaire

    Lille

    Clarisse Eveno, clarisse.eveno@gmail.com

    Recruiting

  • Hospices civils de Lyon

    Lyon

    Olivier Glehen, MD, +33 478862371

    Recruiting

  • Centre du Cancer

    Montpellier

    Olivia Sgarbura, MD, olivia.sgarbura@icm.unicancer.fr

    Recruiting

Other trials in France

Argentina1 site, 1 recruiting

  • Roffo Cancer Institute

    Buenos Aires

    Laura Lay, MD, lauralay@ymail.com

    Recruiting

Other trials in Argentina

Australia1 site, 1 recruiting

  • Peter MacCallum Cancer Centre

    Melbourne

    Craig Lynch, MD

    Recruiting

Other trials in Australia

Austria1 site, 1 recruiting

  • SALK - Salzburger Landeskliniken

    Salzburg

    Tarkan Jäger, MD

    ta.jaeger@salk.at

    Recruiting

Other trials in Austria

Belgium1 site, 1 recruiting

  • University Hospital Gent (UZ Gent)

    Ghent, 9000

    Woulter Willaert, MD, wouter.willaert@ugent.be

    Recruiting

Other trials in Belgium

Denmark1 site, 1 recruiting

  • University Hospital Odense

    Odense

    Martin Graversen, MD, martin.graversen@rsyd.dk

    Recruiting

Other trials in Denmark

Germany1 site, 1 recruiting

  • University Hospital Tübingen

    Tübingen, 72076

    Verena Schlaich, +4970712986722, pipac@med.uni-tuebingen.de

    Recruiting

Other trials in Germany

Italy1 site, 1 recruiting

  • IRCC Torino Candiolo

    Turin

    Marco Vaira, MD, marco.vaira@ircc.it

    Recruiting

Other trials in Italy

Poland1 site, 1 recruiting

  • F. Łukaszczyk Oncology Centre

    Bydgoszcz

    Maciej Nowacki, MD, maciej.s.nowacki@gmail.com

    Recruiting

Other trials in Poland

Russia1 site, 1 recruiting

  • Gersten Institute for Cancer Research

    Moscow

    Vladimir Khomyakov, MD, vladimirkhom@mail.ru

    Recruiting

Other trials in Russia

Singapore1 site, 1 recruiting

  • National University Hospital

    Singapore

    Janelle Phua, niam_sin_phua@nuhs.edu.sg

    Recruiting

Other trials in Singapore

Spain1 site, 1 recruiting

  • Hospital de Pilar

    Barcelona

    Juan Torrent, MD, juanjotorrent@yahoo.es

    Recruiting

Other trials in Spain

Switzerland1 site, 1 recruiting

  • University Hospital Lausanne CHUV

    Lausanne, 1011

    Martin Huebner, MD, chv.carcinose@chuv.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Multicenter, International Online Documentation of Indications and Results of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC Und PITAC) for Treating Malignant Peritoneal and Pleural Diseases

Multicentric, international, web-based prospective documentation of the indications and results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant pleural and peritoneal diseases. Indication is decided by the treating physician. There are no predefined inclusion or exclusion criteria.

Read the detailed description

All data entered into the registry documenting the patient cohort characteristics (disease, demography, therapy) are analyzed using descriptive statistics. Survival data are analyzed with Kaplan-Meier statistics. Multivariate Cox Proportional Hazard Models are used to identify potential prognostic and predictive factors. In particular, a risk- adjusted comparison of the outcome criteria with a propensity score is planned.

The data are stored in a SQL-based online database. Patient data are pseudoanonymized. The registry has received approval of the data protection officer of the State of Northrhine-Westphalia.

The study steering committee is blinded towards the identity of the participating institutions. Each participating institution receives an annual report with own data vs. benchmark. Scientific analysis can be proposed by the steering committee, by a participating institution or by other scientists, subjected to the approval of the independent scientific advisory board.

An export function has been built in to allow data exchange with the HIPEC Registry of the German Society for General and GI surgery (http://www.dgav.de/studoq/studoqhipec.html).

Being tested
PIPAC
Keywords
Pressurized IntraPeritoneal Aerosol Chemotherapy, PIPAC, Pressurized IntraThoracic Aerosol Chemotherapy, PITAC, Cisplatin, Oxaliplatin, Gemcitabine, Paclitaxel, nab-Paclitaxel, Doxorubicine, Mitomycin
Medical subject headings
Peritoneal Neoplasms, Pleural Effusion, Mesothelioma, Malignant, Ovarian Neoplasms, Stomach Neoplasms, Appendiceal Neoplasms, Pseudomyxoma Peritonei, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PIPACCombination product

    Also called PITAC, Intraperitoneal chemotherapy, Intrathoracic chemotherapy

    A chemotherapeutic solution is aerosolized into the expanded abdominal cavity during laparoscopy, under pressure. This allows a relatively homogeneous repartition of the drug and an effective tissue penetration.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Kaplan-Meier

    Measured: 1 to 5 years

Secondary outcomes (4)

  1. Clinical Benefit Rate

    according to RECIST criteria (CR + PR + SD)

    Measured: 3 months

  2. Histological tumor regression according to the Peritoneal Regression Grading Score (PRGS)

    according to the Peritoneal Regression Grading Score (PRGS)

    Measured: 6 weeks

  3. Safety according to CTCAE 4.0

    according to CTCAE 4.0

    Measured: 6 weeks

  4. Quality of life according to QLQ-30 of EORTC

    according to QLQ-30 of EORTC

    Measured: 6-18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2017
  2. Study startJan 2016
  3. Primary completionSep 2022 (estimated)
  4. Study completionSep 2022 (estimated)

Resources

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
1,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03210298
Sponsor's protocol ID
RUB 15-5280
Acronym
PIPACRegis
Status last verified
Oct 2019
First submitted
29 Jun 2017
Last updated
8 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Requests can be addressed to the Scientific Advisory Board, AnInstitut für Qualitässicherung in der operativen Medizin gGmbH, Leipziger Str. 44, 39120 MAGDEBURG, Germany

Publications

  • Graversen M, Detlefsen S, Bjerregaard JK, Pfeiffer P, Mortensen MB. Peritoneal metastasis from pancreatic cancer treated with pressurized intraperitoneal aerosol chemotherapy (PIPAC). Clin Exp Metastasis. 2017 Jun;34(5):309-314. doi: 10.1007/s10585-017-9849-7. Epub 2017 May 17.

    PubMed 28516306

  • Grass F, Vuagniaux A, Teixeira-Farinha H, Lehmann K, Demartines N, Hubner M. Systematic review of pressurized intraperitoneal aerosol chemotherapy for the treatment of advanced peritoneal carcinomatosis. Br J Surg. 2017 May;104(6):669-678. doi: 10.1002/bjs.10521.

    PubMed 28407227

  • Hubner M, Teixeira Farinha H, Grass F, Wolfer A, Mathevet P, Hahnloser D, Demartines N. Feasibility and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Carcinomatosis: A Retrospective Cohort Study. Gastroenterol Res Pract. 2017;2017:6852749. doi: 10.1155/2017/6852749. Epub 2017 Feb 26.

    PubMed 28331493

  • Teixeira Farinha H, Grass F, Kefleyesus A, Achtari C, Romain B, Montemurro M, Demartines N, Hubner M. Impact of Pressurized Intraperitoneal Aerosol Chemotherapy on Quality of Life and Symptoms in Patients with Peritoneal Carcinomatosis: A Retrospective Cohort Study. Gastroenterol Res Pract. 2017;2017:4596176. doi: 10.1155/2017/4596176. Epub 2017 Feb 21.

    PubMed 28316621

  • Tempfer CB, Hartmann F, Hilal Z, Rezniczek GA. Intraperitoneal cisplatin and doxorubicin as maintenance chemotherapy for unresectable ovarian cancer: a case report. BMC Cancer. 2017 Jan 6;17(1):26. doi: 10.1186/s12885-016-3004-8.

    PubMed 28061769

  • Girshally R, Demtroder C, Albayrak N, Zieren J, Tempfer C, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) as a neoadjuvant therapy before cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. World J Surg Oncol. 2016 Sep 27;14(1):253. doi: 10.1186/s12957-016-1008-0.

    PubMed 27678344

  • Graversen M, Pfeiffer P, Mortensen MB. [Treatment of peritoneal carcinomatosis with pressurized intraperitoneal aerosol chemotherapy]. Ugeskr Laeger. 2016 May 23;178(21):V11150928. Danish.

    PubMed 27237925

  • Robella M, Vaira M, De Simone M. Safety and feasibility of pressurized intraperitoneal aerosol chemotherapy (PIPAC) associated with systemic chemotherapy: an innovative approach to treat peritoneal carcinomatosis. World J Surg Oncol. 2016 Apr 29;14:128. doi: 10.1186/s12957-016-0892-7.

    PubMed 27125996

  • Tempfer CB, Rezniczek GA, Ende P, Solass W, Reymond MA. Pressurized Intraperitoneal Aerosol Chemotherapy with Cisplatin and Doxorubicin in Women with Peritoneal Carcinomatosis: A Cohort Study. Anticancer Res. 2015 Dec;35(12):6723-9. doi: 10.1055/s-0035-1560004.

    PubMed 26637888

  • Nadiradze G, Giger-Pabst U, Zieren J, Strumberg D, Solass W, Reymond MA. Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with Low-Dose Cisplatin and Doxorubicin in Gastric Peritoneal Metastasis. J Gastrointest Surg. 2016 Feb;20(2):367-73. doi: 10.1007/s11605-015-2995-9. Epub 2015 Oct 28.

    PubMed 26511950

  • Demtroder C, Solass W, Zieren J, Strumberg D, Giger-Pabst U, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy with oxaliplatin in colorectal peritoneal metastasis. Colorectal Dis. 2016 Apr;18(4):364-71. doi: 10.1111/codi.13130.

    PubMed 26400556

  • Hubner M, Teixeira H, Boussaha T, Cachemaille M, Lehmann K, Demartines N. [PIPAC--Pressurized intraperitoneal aerosol chemotherapy. A novel treatment for peritoneal carcinomatosis]. Rev Med Suisse. 2015 Jun 17;11(479):1325-30. French.

    PubMed 26255492

  • Odendahl K, Solass W, Demtroder C, Giger-Pabst U, Zieren J, Tempfer C, Reymond MA. Quality of life of patients with end-stage peritoneal metastasis treated with Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC). Eur J Surg Oncol. 2015 Oct;41(10):1379-85. doi: 10.1016/j.ejso.2015.06.001. Epub 2015 Jun 21.

    PubMed 26138283

  • Tempfer CB, Solass W, Buerkle B, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in a woman with pseudomyxoma peritonei: A case report. Gynecol Oncol Rep. 2014 Oct 18;10:32-5. doi: 10.1016/j.gore.2014.10.001. eCollection 2014 Dec.

    PubMed 26076000

  • Giger-Pabst U, Solass W, Buerkle B, Reymond MA, Tempfer CB. Low-dose pressurized intraperitoneal aerosol chemotherapy (PIPAC) as an alternative therapy for ovarian cancer in an octogenarian patient. Anticancer Res. 2015 Apr;35(4):2309-14.

    PubMed 25862894

Questions about this trial

What is this clinical trial studying?

An observational study of Peritoneum Cancer and Peritoneum Neoplasm, run by Sabine Rhode at 16 sites in 13 countries.

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 10 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 8 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 16 sites in France, Argentina, Australia, Austria, Belgium and 8 more countries. 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 Sabine Rhode (+49 391 67 17960, sabine.rhode@med.ovgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 1 to 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 NCT03210298, which also lists 21 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 8 Oct 2019.

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