Trial reportBMC cancer2026
Adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC) in suboptimally cytoreduced advanced ovarian cancer: a randomized phase II trial (PIPAC-OVA).
Trial report in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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7 authors.
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Abstract
purposePatients with advanced epithelial ovarian cancer (EOC) who undergo suboptimal primary cytoreductive surgery (PCS) have poor outcomes with standard platinum-taxane chemotherapy. This randomized controlled trial evaluated whether adding adjuvant Pressurized Intraperitoneal Aerosol Chemotherapy with low-dose cisplatin and doxorubicin (PIPAC C/D) to first-line systemic therapy improves survival in this high-risk population.
methodsIn this single-center, open-label trial, patients with advanced EOC and residual disease > 1 cm after PCS were randomly assigned (1:1) to receive six cycles of carboplatin/paclitaxel alone (control arm) or the same chemotherapy plus three adjuvant PIPAC C/D procedures (intervention arm). No patient received neoadjuvant chemotherapy. The primary endpoint was progression-free survival (PFS) from PCS. Secondary end points included overall survival (OS), CA-125 response, peritoneal disease control assessed macroscopically and histologically, and safety.
trial registrationISRCTN15843444.
resultsA total of 186 patients were randomized. After excluding four after definitive histology, 182 comprised the mITT population (control, n = 91; PIPAC, n = 91). Median PFS was significantly longer with PIPAC (19.7 vs 12.5 months; HR, 0.31; 95% CI, 0.23-0.42; P < 0.001), as was OS (46.2 vs 38.1 months; HR, 0.48; 95% CI, 0.32-0.72; P < 0.001). In the PIPAC group, complete macroscopic regression occurred in 98.8% (83/84 treated patients), complete pathological regression in 85.7%, and ascites control in 98.8%. Treatment was well tolerated with no increase in grade 3-4 toxicity and minimal procedure-related morbidity.
conclusionIn patients with suboptimally debulked advanced EOC, the addition of adjuvant PIPAC C/D to first-line chemotherapy significantly improved PFS and OS while maintaining a favorable safety profile. These findings support further evaluation of PIPAC C/D as a component of primary treatment in this high-risk subgroup in confirmatory phase III trials.
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