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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03210298




Registration number
NCT03210298
Ethics application status
Date submitted
29/06/2017
Date registered
6/07/2017
Date last updated
8/10/2019

Titles & IDs
Public title
International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)
Scientific title
Multicenter, International Online Documentation of Indications and Results of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC Und PITAC) for Treating Malignant Peritoneal and Pleural Diseases
Secondary ID [1] 0 0
RUB 15-5280
Universal Trial Number (UTN)
Trial acronym
PIPACRegis
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peritoneum Cancer 0 0
Peritoneum Neoplasm 0 0
Pleural Cancer 0 0
Pleural Effusion 0 0
Pleural Mesothelioma 0 0
Ovarian Cancer 0 0
Gastric Cancer 0 0
Appendix Cancer 0 0
Pseudomyxoma Peritonei 0 0
Colorectal Cancer 0 0
Pancreas Cancer 0 0
Gallbladder Cancer 0 0
Ascites 0 0
CUP 0 0
Chemotherapeutic Toxicity 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Cancer 0 0 0 0
Pancreatic
Cancer 0 0 0 0
Other cancer types
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Combination Product - PIPAC

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.

Intervention code [1] 0 0
Combination Product
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival - Kaplan-Meier
Timepoint [1] 0 0
1 to 5 years
Secondary outcome [1] 0 0
Clinical Benefit Rate - according to RECIST criteria (CR + PR + SD)
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Histological tumor regression according to the Peritoneal Regression Grading Score (PRGS) - according to the Peritoneal Regression Grading Score (PRGS)
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
Safety according to CTCAE 4.0 - according to CTCAE 4.0
Timepoint [3] 0 0
6 weeks
Secondary outcome [4] 0 0
Quality of life according to QLQ-30 of EORTC - according to QLQ-30 of EORTC
Timepoint [4] 0 0
6-18 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

- verified peritoneal metastasis

- colorectal cancer

- ovarian cancer

- gastric cancer

- appendical cancer

- pseudomyxoma peritonei

- malignant mesothelioma

- pancreatic cancer

- gallbladder cancer

- small bowel cancer
Minimum age
10 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

- bowel obstruction

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Denmark
State/province [4] 0 0
Odense
Country [5] 0 0
France
State/province [5] 0 0
Grenoble
Country [6] 0 0
France
State/province [6] 0 0
Lille
Country [7] 0 0
France
State/province [7] 0 0
Lyon
Country [8] 0 0
France
State/province [8] 0 0
Montpellier
Country [9] 0 0
Germany
State/province [9] 0 0
Tübingen
Country [10] 0 0
Italy
State/province [10] 0 0
Turin
Country [11] 0 0
Poland
State/province [11] 0 0
Bydgoszcz
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Moscow
Country [13] 0 0
Singapore
State/province [13] 0 0
Singapore
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Switzerland
State/province [15] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Other
Name
Sabine Rhode
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Ruhr University of Bochum
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03210298
Trial related presentations / 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.
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.
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.
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, 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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, 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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Philipp Horvath, MD
Address 0 0
University Hospital Tuebingen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sabine Rhode
Address 0 0
Country 0 0
Phone 0 0
+49 391 67 17960
Fax 0 0
Email 0 0
sabine.rhode@med.ovgu.de
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03210298