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

Colorectal Cancer Clinical Trial

— PIPACRegis  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03210298
• Other study ID #: RUB 15-5280
• Status: Recruiting
• Start date: January 2016
• Est. completion date: September 2022

Study information

• Verified date: October 2019
• Source: University of Magdeburg
• Contact: Sabine Rhode
• Phone: +49 391 67 17960
• Email: sabine.rhode[@]med.ovgu.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Appendiceal Neoplasms
• Appendix Cancer
• Ascites
• Chemotherapeutic Toxicity
• Colorectal Cancer
• CUP
• Gallbladder Cancer
• Gallbladder Neoplasms
• Gastric Cancer
• Mesothelioma
• Ovarian Cancer
• Pancreas Cancer
• Pancreatic Neoplasms
• Peritoneum Cancer
• Peritoneum Neoplasm
• Pleural Cancer
• Pleural Effusion
• Pleural Mesothelioma
• Pseudomyxoma Peritonei

Intervention

Combination Product:
• PIPAC
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.

Locations

Country	Name	City	State
Argentina	Roffo Cancer Institute	Buenos Aires
Australia	Peter MacCallum Cancer Centre	Melbourne
Austria	SALK - Salzburger Landeskliniken	Salzburg
Belgium	University Hospital Gent (UZ Gent)	Gent
Denmark	University Hospital Odense	Odense
France	Centre Hospitalier Universitaire	Grenoble
France	Centre Hospitalier Universitaire	Lille
France	Hospices civils de Lyon	Lyon
France	Centre du Cancer	Montpellier
Germany	University Hospital Tübingen	Tübingen
Italy	IRCC Torino Candiolo	Turin
Poland	F. Lukaszczyk Oncology Centre	Bydgoszcz
Russian Federation	Gersten Institute for Cancer Research	Moscow
Singapore	National University Hospital	Singapore
Spain	Hospital de Pilar	Barcelona
Switzerland	University Hospital Lausanne CHUV	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
Sabine Rhode	Ruhr University of Bochum

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Denmark,  France,  Germany,  Italy,  Poland,  Russian Federation,  Singapore,  Spain,  Switzerland, 

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Kaplan-Meier	1 to 5 years
Secondary	Clinical Benefit Rate	according to RECIST criteria (CR + PR + SD)	3 months
Secondary	Histological tumor regression according to the Peritoneal Regression Grading Score (PRGS)	according to the Peritoneal Regression Grading Score (PRGS)	6 weeks
Secondary	Safety according to CTCAE 4.0	according to CTCAE 4.0	6 weeks
Secondary	Quality of life according to QLQ-30 of EORTC	according to QLQ-30 of EORTC	6-18 weeks