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

• Sponsor: Sabine Rhode (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03210298
• Collaborator: Ruhr University of Bochum (Other)
• Enrollment: 1,000
• Locations: 16
• Anticipated Duration (Months): 80
• Patients Per Site: 62.5
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Combination Product: PIPAC

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).

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jan 1, 2016
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Outcome Measures

Primary Outcome Measures

1. Overall survival [1 to 5 years]

   Kaplan-Meier

Secondary Outcome Measures

1. Clinical Benefit Rate [3 months]

   according to RECIST criteria (CR + PR + SD)

2. Histological tumor regression according to the Peritoneal Regression Grading Score (PRGS) [6 weeks]

   according to the Peritoneal Regression Grading Score (PRGS)

3. Safety according to CTCAE 4.0 [6 weeks]

   according to CTCAE 4.0

4. Quality of life according to QLQ-30 of EORTC [6-18 weeks]

   according to QLQ-30 of EORTC

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• verified peritoneal metastasis

• colorectal cancer

• ovarian cancer

• gastric cancer

• appendical cancer

• pseudomyxoma peritonei

• malignant mesothelioma

• pancreatic cancer

• gallbladder cancer

• small bowel cancer

Exclusion criteria

• bowel obstruction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roffo Cancer Institute	Buenos Aires		Argentina
2	Peter MacCallum Cancer Centre	Melbourne		Australia
3	SALK - Salzburger Landeskliniken	Salzburg		Austria
4	University Hospital Gent (UZ Gent)	Gent		Belgium	9000
5	University Hospital Odense	Odense		Denmark
6	Centre Hospitalier Universitaire	Grenoble		France
7	Centre Hospitalier Universitaire	Lille		France
8	Hospices civils de Lyon	Lyon		France
9	Centre du Cancer	Montpellier		France
10	University Hospital Tübingen	Tübingen		Germany	72076
11	IRCC Torino Candiolo	Turin		Italy
12	F. Łukaszczyk Oncology Centre	Bydgoszcz		Poland
13	Gersten Institute for Cancer Research	Moscow		Russian Federation
14	National University Hospital	Singapore		Singapore
15	Hospital de Pilar	Barcelona		Spain
16	University Hospital Lausanne CHUV	Lausanne		Switzerland	1011

Sponsors and Collaborators

• Sabine Rhode
• Ruhr University of Bochum

Investigators

• Principal Investigator: Philipp Horvath, MD, University Hospital Tuebingen

Study Documents (Full-Text)

None provided.

More Information

Publications

• Demtröder 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.
• 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.
• Girshally R, Demtröder 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.
• Grass F, Vuagniaux A, Teixeira-Farinha H, Lehmann K, Demartines N, Hübner 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. Review.
• 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.
• Graversen M, Pfeiffer P, Mortensen MB. [Treatment of peritoneal carcinomatosis with pressurized intraperitoneal aerosol chemotherapy]. Ugeskr Laeger. 2016 May 23;178(21). pii: V11150928. Review. Danish.
• Hübner 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.
• Hübner 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.
• 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.
• Odendahl K, Solass W, Demtröder 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.
• 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.
• 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. French.
• Solass W, Kerb R, Mürdter 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.
• Teixeira Farinha H, Grass F, Kefleyesus A, Achtari C, Romain B, Montemurro M, Demartines N, Hübner 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.
• 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.
• 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.
• 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.
• 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.
• 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. Review.
• 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.

• Responsible Party: Sabine Rhode, Coordinator, University of Magdeburg
• ClinicalTrials.gov Identifier: NCT03210298
• Other Study ID Numbers: RUB 15-5280
• First Posted: Jul 6, 2017
• Last Update Posted: Oct 8, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Sabine Rhode, Coordinator, University of Magdeburg: Pressurized IntraPeritoneal Aerosol Chemotherapy; PIPAC; Pressurized IntraThoracic Aerosol Chemotherapy; PITAC; Cisplatin; Oxaliplatin; Gemcitabine; Paclitaxel; nab-Paclitaxel; Doxorubicine; Mitomycin
• Additional relevant MeSH terms: Mesothelioma; Pancreatic Neoplasms; Gallbladder Neoplasms; Pseudomyxoma Peritonei; Appendiceal Neoplasms; Pleural Effusion; Ascites

Study Results

No Results Posted as of Oct 8, 2019