Current Research and Development in Hyperthermic Intraperitoneal Chemotherapy (HIPEC)-A Cross-Sectional Analysis of Clinical Trials Registered on ClinicalTrials.gov.

Ukegjini, Kristjan; Guidi, Marisa; Lehmann, Kuno; Süveg, Krisztian; Putora, Paul Martin; Cihoric, Nikola; Steffen, Thomas (2023). Current Research and Development in Hyperthermic Intraperitoneal Chemotherapy (HIPEC)-A Cross-Sectional Analysis of Clinical Trials Registered on ClinicalTrials.gov. Cancers, 15(7) MDPI AG 10.3390/cancers15071926

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INTRODUCTION

Over the past two decades, cytoreductive surgery and HIPEC has improved outcomes for selected patients with peritoneal metastasis from various origins. This is a cross-sectional study with descriptive analyses of HIPEC trials registered on ClinicalTrials.gov. This study aimed to characterize clinical trials on HIPEC registered on ClinicalTrials.gov with the primary objective of identifying a trial focus and to examine whether trial results were published.

METHODS

The search included trials registered from 1 January 2001 to 14 March 2022. We examined the associations of exposure variables and other trial features with two primary outcomes: therapeutic focus and results reporting.

RESULTS

In total, 234 clinical trials were identified; 26 (11%) were already published, and 15 (6%) trials have reported their results but have not been published as full papers. Among ongoing nonpublished trials, 81 (39%) were randomized, 30 (14%) were blinded, n = 39 (20%) were later phase trials (i.e., phases 3 and 4), n = 152 (73%) were from a single institution, and 91 (44%) had parallel groups. Most of the trials were recruiting at the time of this analysis (75, 36%), and 39 (20%) were completed but had yet to publish results. In total, 68% of the trials focused on treatment strategies, and 53% investigated the oncological outcome. The most studied neoplasms for HIPEC trials were peritoneally metastasized colorectal cancer (32%), gastric cancer (29%), and ovarian cancer (26%). Twenty different drugs were analyzed in these clinical trials.

CONCLUSIONS

Many study results are awaited from ongoing HIPEC trials. Most HIPEC trials focused on gastric, colorectal, or ovarian cancer. Many clinical trials were identified involving multiple entities and chemotherapeutic agents.

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