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

NCT03210298 | Unknown FDA Drug

• 1 other identifier: RUB 15-5280
• Study Type: observational
• Target: 1,000
• Locations: 12 countries
• Sites: 15

Brief 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.

Conditions

Peritoneum Cancer; Peritoneum Neoplasm; Pleural Cancer; Pleural Effusion; Pleural Mesothelioma; Ovarian Cancer; Gastric Cancer; Appendix Cancer; Pseudomyxoma Peritonei; Colorectal Cancer; Pancreas Cancer; Gallbladder Cancer; Ascites; CUP; Chemotherapeutic Toxicity

Keywords

Pressurized IntraPeritoneal Aerosol Chemotherapy; PIPAC; Pressurized IntraThoracic Aerosol Chemotherapy; PITAC; Cisplatin; Oxaliplatin; Gemcitabine; Paclitaxel; nab-Paclitaxel; Doxorubicine; Mitomycin

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Kaplan-Meier

  1 to 5 years

Secondary Outcomes (4)

• Clinical Benefit Rate

  3 months

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

  6 weeks

• Safety according to CTCAE 4.0

  6 weeks

• Quality of life according to QLQ-30 of EORTC

  6-18 weeks

Interventions

PIPAC COMBINATION_PRODUCT

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.

Also known as: PITAC, Intraperitoneal chemotherapy, Intrathoracic chemotherapy

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \- bowel obstruction

Sponsors & Collaborators

• Sabine Rhode: lead
• Ruhr University of Bochum: collaborator

Study Sites (16)

Roffo Cancer Institute

Buenos Aires, Argentina

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Australia

RECRUITING

SALK - Salzburger Landeskliniken

Salzburg, Austria

RECRUITING

University Hospital Gent (UZ Gent)

Ghent, 9000, Belgium

RECRUITING

University Hospital Odense

Odense, Denmark

RECRUITING

Centre Hospitalier Universitaire

Grenoble, France

RECRUITING

Centre Hospitalier Universitaire

Lille, France

RECRUITING

Hospices civils de Lyon

Lyon, France

RECRUITING

Centre du Cancer

Montpellier, France

RECRUITING

University Hospital Tübingen

Tübingen, 72076, Germany

RECRUITING

IRCC Torino Candiolo

Turin, Italy

RECRUITING

F. Łukaszczyk Oncology Centre

Bydgoszcz, Poland

RECRUITING

Gersten Institute for Cancer Research

Moscow, Russia

RECRUITING

National University Hospital

Singapore, Singapore

RECRUITING

Hospital de Pilar

Barcelona, Spain

RECRUITING

University Hospital Lausanne CHUV

Lausanne, 1011, Switzerland

RECRUITING

Related Publications (21)

• 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.

  PMID: 28516306 BACKGROUND

• 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.

  PMID: 28407227 BACKGROUND

• 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.

  PMID: 28331493 BACKGROUND

• 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.

  PMID: 28316621 BACKGROUND

• 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.

  PMID: 28061769 BACKGROUND

• 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.

  PMID: 27678344 BACKGROUND

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

  PMID: 27237925 BACKGROUND

• 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.

  PMID: 27125996 BACKGROUND

• 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.

  PMID: 26637888 BACKGROUND

• 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.

  PMID: 26511950 BACKGROUND

• 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.

  PMID: 26400556 BACKGROUND

• 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.

  PMID: 26255492 BACKGROUND

• 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.

  PMID: 26138283 BACKGROUND

• 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.

  PMID: 26076000 BACKGROUND

• 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.

  PMID: 25862894 BACKGROUND

• Tempfer CB, Winnekendonk G, Solass W, Horvat R, Giger-Pabst U, Zieren J, Rezniczek GA, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy in women with recurrent ovarian cancer: A phase 2 study. Gynecol Oncol. 2015 May;137(2):223-8. doi: 10.1016/j.ygyno.2015.02.009. Epub 2015 Feb 18.

  PMID: 25701703 BACKGROUND

• Sabaila A, Fauconnier A, Huchon C. [Pressurized intraperitoneal aerosol chemotherapy (PIPAC): a new way of administration in peritoneal carcinomatosis of ovarian cancer]. Gynecol Obstet Fertil. 2015 Jan;43(1):66-7. doi: 10.1016/j.gyobfe.2014.11.012. Epub 2014 Dec 15. No abstract available. French.

  PMID: 25523545 BACKGROUND

• Tempfer CB, Solass W, Reymond MA. Pressurized intraperitoneal chemotherapy (PIPAC) in women with gynecologic malignancies: a review. Wien Med Wochenschr. 2014 Dec;164(23-24):519-28. doi: 10.1007/s10354-014-0312-y. Epub 2014 Sep 24.

  PMID: 25249025 BACKGROUND

• Tempfer CB, Celik I, Solass W, Buerkle B, Pabst UG, Zieren J, Strumberg D, Reymond MA. Activity of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin and doxorubicin in women with recurrent, platinum-resistant ovarian cancer: preliminary clinical experience. Gynecol Oncol. 2014 Feb;132(2):307-11. doi: 10.1016/j.ygyno.2013.11.022. Epub 2013 Nov 23.

  PMID: 24275155 BACKGROUND

• Solass W, Kerb R, Murdter T, Giger-Pabst U, Strumberg D, Tempfer C, Zieren J, Schwab M, Reymond MA. Intraperitoneal chemotherapy of peritoneal carcinomatosis using pressurized aerosol as an alternative to liquid solution: first evidence for efficacy. Ann Surg Oncol. 2014 Feb;21(2):553-9. doi: 10.1245/s10434-013-3213-1. Epub 2013 Sep 5.

  PMID: 24006094 BACKGROUND

• Kurtz F, Struller F, Horvath P, Solass W, Bosmuller H, Konigsrainer A, Reymond MA. Feasibility, Safety, and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastasis: A Registry Study. Gastroenterol Res Pract. 2018 Oct 24;2018:2743985. doi: 10.1155/2018/2743985. eCollection 2018.

  PMID: 30473706 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peritoneal samples

MeSH Terms

Conditions

Peritoneal Neoplasms; Pleural Effusion; Mesothelioma, Malignant; Ovarian Neoplasms; Stomach Neoplasms; Appendiceal Neoplasms; Pseudomyxoma Peritonei; Colorectal Neoplasms; Pancreatic Neoplasms; Gallbladder Neoplasms; Ascites

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Pleural Diseases; Respiratory Tract Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Lung Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Cecal Neoplasms; Intestinal Neoplasms; Cecal Diseases; Intestinal Diseases; Adenocarcinoma, Mucinous; Adenocarcinoma; Carcinoma; Neoplasms, Cystic, Mucinous, and Serous; Colonic Diseases; Rectal Diseases; Pancreatic Diseases; Biliary Tract Neoplasms; Biliary Tract Diseases; Gallbladder Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Philipp Horvath, MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabine Rhode

CONTACT

+49 391 67 17960; sabine.rhode@med.ovgu.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinator

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 6, 2017
• Study Start: January 1, 2016
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: until 2021/12/31
• Access Criteria: Approval through the independent scientific advisory board of the Institut for Quality Control, see above

Locations

AU (1); AR (1); RU (1); DK (1); SG (1); PL (1); DE (1); BE (1); FR (4); IT (1); CH (1); ES (1)