{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T05:56:50Z","timestamp":1790056610736,"version":"4.0.1"},"reference-count":13,"publisher":"Walter de Gruyter GmbH","issue":"3","license":[{"start":{"date-parts":[[2018,9,1]],"date-time":"2018-09-01T00:00:00Z","timestamp":1535760000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,9,25]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_pp-2018-0114_s_017_w2aab3b7b2b1b6b1aab1c16b1Aa\">\n                    <jats:title id=\"d5788578e2519_w2aab3b7b2b1b6b1aab1c16b1aAa\">Background<\/jats:title>\n                    <jats:p>\n                      Recurrent, platin-resistant ovarian cancer (rPROC) has a poor survival. Even with the AURELIA trial, which is the best available treatment today, progression-free survival (PFS) is still only 6.7 months from the start of the second-line chemotherapy. Innovative, effective therapies are urgently needed. Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) is a novel drug delivery system for administering drugs into the abdomen. PIPAC with cisplatin and doxorubicin (PIPAC C\/D) may be safely used at an intraperitoneal dose of 10.5\u2006mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      and 2.1\u2006mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      , respectively. Systemic toxicity of this therapy is low. In a phase II trial with 53 women, 62\u2006% patients had an objective tumor response. Tumor regression on histology was observed in 76\u2006% patients who underwent all three PIPACs. Randomized phase III studies are now required to evaluate the effect of PIPAC C\/D compared to other standard treatments (sequential or simultaneous applications with systemic chemotherapy).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_pp-2018-0114_s_018_w2aab3b7b2b1b6b1aab1c16b2Aa\">\n                    <jats:title id=\"d5788578e2534_w2aab3b7b2b1b6b1aab1c16b2aAa\">Methods<\/jats:title>\n                    <jats:p>The present phase III study is a prospective, open, randomized, multicentric pivotal trial. A total of 244 patients will be randomly assigned (1:1) to the control (A) or to the experimental (B) group. Group A: Systemic palliative chemotherapy, physician\u2019s best choice (monotherapy consisting of pegylated liposomal doxorubicin or topotecan or gemcitabine or paclitaxel weekly. Bevacizumab can be used in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin). Group B: Intraperitoneal chemotherapy, 3\u00d7PIPAC C\/D, performed every 6 weeks. Combination with systemic therapy is not allowed. Treatment is continued until disease progression, death, or patient refusal. In case of progression, no recommendation for further therapy is given by protocol. Patients are allowed to receive PIPAC C\/D or systemic chemotherapy after study termination. The primary endpoint is PFS (according to RECIST v1.1) or death from any cause. The co-primary endpoint is the health-related quality of life (HRQoL) measured as the global health status (GHS, QLQ-30 of EORTC). Secondary outcomes comprise overall survival, safety (CTCAE 5.0), and tumor response according to peritoneal regression grading score (PRGS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_pp-2018-0114_s_019_w2aab3b7b2b1b6b1aab1c16b3Aa\">\n                    <jats:title id=\"d5788578e2543_w2aab3b7b2b1b6b1aab1c16b3aAa\">Discussion<\/jats:title>\n                    <jats:p>We expect PIPAC C\/D to control peritoneal disease and preserve the QoL on this subset of patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_pp-2018-0114_s_020_w2aab3b7b2b1b6b1aab1c16b4Aa\">\n                    <jats:title id=\"d5788578e2552_w2aab3b7b2b1b6b1aab1c16b4aAa\">Trial registration<\/jats:title>\n                    <jats:p>The EudraCT number 2018-003664-31<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/pp-2018-0114","type":"journal-article","created":{"date-parts":[[2018,9,28]],"date-time":"2018-09-28T05:04:58Z","timestamp":1538111098000},"source":"Crossref","is-referenced-by-count":37,"title":["PIPAC-OV3: A multicenter, open-label, randomized, two-arm phase III trial of the effect on progression-free survival of cisplatin and doxorubicin as Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) vs. chemotherapy alone in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer"],"prefix":"10.1515","volume":"3","author":[{"given":"Naoual","family":"Bakrin","sequence":"first","affiliation":[{"name":"Service de chirurgie g\u00e9n\u00e9rale et digestive , Centre Hospitalier Universitaire Lyon-Sud, Universit\u00e9 Claude Bernard , Lyon , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clemens","family":"Tempfer","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics , Ruhr-University Bochum , Bochum , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Scambia","sequence":"additional","affiliation":[{"name":"Department of Gynecology , Policlinco Gemelli, Catholic University , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"De Simone","sequence":"additional","affiliation":[{"name":"Istituto per la Ricerca e la Cura del Cancro , Torino , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boris","family":"Gabriel","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics , St Josefs-Hospital , Wiesbaden , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva-Maria","family":"Grischke","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics , University Hospital , T\u00fcbingen , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beate","family":"Rau","sequence":"additional","affiliation":[{"name":"Charit\u00e9 University Medicine , Berlin , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"The French Oncologic and Gynecologic HIPEC \u2013 FROGHI Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2018,9,25]]},"reference":[{"key":"2025120909212497699_j_pp-2018-0114_ref_001_w2aab3b7b2b1b6b1ab1c17b1Aa","unstructured":"International Agency for Research on Cancer. 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