Clinical Studies in CRS and HIPEC: Trials, Tribulations, and Future Directions-A Systematic Review

Overview

Journal J Surg Oncol

Specialties General Surgery
Oncology

Date 2017 Nov 10

PMID 29120491

Citations 26

Authors

William F Morano

Marian Khalili

Dennis S Chi

Wilbur B Bowne

Jesus Esquivel

Affiliations

Soon will be listed here.

Abstract

Background: The field of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has suffered from a lack of clinical trials to validate its expanding use.

Objective: To evaluate published and ongoing clinical trials seeking to better define role of CRS/HIPEC in the treatment of peritoneal surface malignancies.

Methods: Systematic review by PubMed search was performed using terms "Clinical trial," "intraperitoneal chemotherapy," and "HIPEC." ClinicalTrials.gov and EudraCT registries were searched for active clinical trials. Eligibility included CRS/HIPEC trials investigating adult patient populations from published clinical reports and/or trials currently accruing or at completion.

Results: Thirteen published trials and 57 active clinical trials were included for review.

Conclusions: Published and ongoing U.S. and international clinical trials for CRS and HIPEC are defining important parameters that include improving patient selection, strategic sequences of treatment, cytoreductive strategies, chemotherapeutics, optimal hyperthermic temperature and timing, and toxicity profiles. Main barriers or limitations to trial development remain patient enrollment, trial design, and oncologic community collaboration. Overall progress is positive with increasing number of clinical trials throughout the world. Collaboration between surgeons and the wider oncologic community will be crucial to validate this important treatment strategy.

Citing Articles

Effect of glucose-insulin-potassium on lactate levels at the end of surgery in patients undergoing cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy: study protocol for a randomized controlled trial.

Hu Y, Gao T, Wang X, Zhang Q, Wang S, Liu P Trials. 2024; 25(1):708.

PMID: 39438970 PMC: 11515742. DOI: 10.1186/s13063-024-08161-2.

Hyperthermic intraoperative peritoneal chemotherapy and cytoreductive surgery for people with peritoneal metastases: a systematic review and cost-effectiveness analysis.

Gurusamy K, Leung J, Vale C, Roberts D, Linden A, Tan X Health Technol Assess. 2024; 28(51):1-139.

PMID: 39254852 PMC: 11417642. DOI: 10.3310/KWDG6338.

Cytoreductive surgery plus hyperthermic intraoperative peritoneal chemotherapy for people with peritoneal metastases from colorectal, ovarian or gastric origin: A systematic review of randomized controlled trials.

Gurusamy K, Leung J, Vale C, Roberts D, Linden A, Tan X World J Surg. 2024; 48(6):1385-1403.

PMID: 38658171 PMC: 7617159. DOI: 10.1002/wjs.12186.

Reply to Letter to the Editor Concerning "Safety and Efficacy of Oxaliplatin Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Colorectal and Appendiceal Cancer with Peritoneal Metastases: Results of a Multicenter Phase I Trial in the....

Sullivan K, Whelan R, Deperalta D, Merchea A, Dellinger T, Raoof M Ann Surg Oncol. 2024; 31(4):2408-2409.

PMID: 38245647 DOI: 10.1245/s10434-024-14934-5.

Incisional hernias post cytoreductive surgery/peritonectomy and hyperthermic intraperitoneal chemotherapy: a systematic review and meta-analysis.

Mac Curtain B, Qian W, Temperley H, Simpkin A, Ng Z Hernia. 2023; 27(5):1067-1083.

PMID: 37653188 PMC: 10533625. DOI: 10.1007/s10029-023-02859-z.

References

Polyzos A, Tsavaris N, Kosmas C, Giannikos L, Katsikas M, Kalahanis N . A comparative study of intraperitoneal carboplatin versus intravenous carboplatin with intravenous cyclophosphamide in both arms as initial chemotherapy for stage III ovarian cancer. Oncology. 1999; 56(4):291-6. DOI: 10.1159/000011980. View

Park B, Alexander H, Libutti S, Wu P, Royalty D, Kranda K . Treatment of primary peritoneal mesothelioma by continuous hyperthermic peritoneal perfusion (CHPP). Ann Surg Oncol. 1999; 6(6):582-90. DOI: 10.1007/s10434-999-0582-6. View

Sugarbaker P, Chang D . Results of treatment of 385 patients with peritoneal surface spread of appendiceal malignancy. Ann Surg Oncol. 2000; 6(8):727-31. DOI: 10.1007/s10434-999-0727-7. View

Gadducci A, Carnino F, Chiara S, Brunetti I, Tanganelli L, Romanini A . Intraperitoneal versus intravenous cisplatin in combination with intravenous cyclophosphamide and epidoxorubicin in optimally cytoreduced advanced epithelial ovarian cancer: a randomized trial of the Gruppo Oncologico Nord-Ovest. Gynecol Oncol. 2000; 76(2):157-62. DOI: 10.1006/gyno.1999.5677. View

Sugarbaker P . Management of peritoneal-surface malignancy: the surgeon's role. Langenbecks Arch Surg. 2000; 384(6):576-87. DOI: 10.1007/s004230050246. View

Yen M, Juang C, Lai C, Chao G, Ng H, Yuan C . Intraperitoneal cisplatin-based chemotherapy vs. intravenous cisplatin-based chemotherapy for stage III optimally cytoreduced epithelial ovarian cancer. Int J Gynaecol Obstet. 2001; 72(1):55-60. DOI: 10.1016/s0020-7292(00)00340-4. View

Markman M, Bundy B, Alberts D, Fowler J, Carson L, Wadler S . Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: an intergroup study of the.... J Clin Oncol. 2001; 19(4):1001-7. DOI: 10.1200/JCO.2001.19.4.1001. View

Loggie B, Fleming R, McQuellon R, Russell G, Geisinger K, Levine E . Prospective trial for the treatment of malignant peritoneal mesothelioma. Am Surg. 2001; 67(10):999-1003. View

Elias D, Ouellet J . Intraperitoneal chemohyperthermia: rationale, technique, indications, and results. Surg Oncol Clin N Am. 2001; 10(4):915-33, xi. View

10.

Taub R, Keohan M, Chabot J, Fountain K, Plitsas M . Peritoneal mesothelioma. Curr Treat Options Oncol. 2002; 1(4):303-12. DOI: 10.1007/s11864-000-0046-5. View

11.

Jayne D, Fook S, Loi C, Seow-Choen F . Peritoneal carcinomatosis from colorectal cancer. Br J Surg. 2002; 89(12):1545-50. DOI: 10.1046/j.1365-2168.2002.02274.x. View

12.

Glehen O, Mithieux F, Osinsky D, Beaujard A, Freyer G, Guertsch P . Surgery combined with peritonectomy procedures and intraperitoneal chemohyperthermia in abdominal cancers with peritoneal carcinomatosis: a phase II study. J Clin Oncol. 2003; 21(5):799-806. DOI: 10.1200/JCO.2003.06.139. View

13.

Elias D, Laurent S, Antoun S, Duvillard P, Ducreux M, Pocard M . [Pseudomyxoma peritonei treated with complete resection and immediate intraperitoneal chemotherapy]. Gastroenterol Clin Biol. 2003; 27(4):407-12. View

14.

Deraco M, Casali P, Inglese M, Baratti D, Pennacchioli E, Bertulli R . Peritoneal mesothelioma treated by induction chemotherapy, cytoreductive surgery, and intraperitoneal hyperthermic perfusion. J Surg Oncol. 2003; 83(3):147-53. DOI: 10.1002/jso.10255. View

15.

van Ruth S, Acherman Y, van de Vijver M, Hart A, Verwaal V, Zoetmulder F . Pseudomyxoma peritonei: a review of 62 cases. Eur J Surg Oncol. 2003; 29(8):682-8. DOI: 10.1016/s0748-7983(03)00149-5. View

16.

Verwaal V, van Ruth S, de Bree E, van Sloothen G, van Tinteren H, Boot H . Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer. J Clin Oncol. 2003; 21(20):3737-43. DOI: 10.1200/JCO.2003.04.187. View

17.

Goldberg R, Sargent D, Morton R, Fuchs C, Ramanathan R, Williamson S . A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol. 2003; 22(1):23-30. DOI: 10.1200/JCO.2004.09.046. View

18.

Feldman A, Libutti S, Pingpank J, Bartlett D, Beresnev T, Mavroukakis S . Analysis of factors associated with outcome in patients with malignant peritoneal mesothelioma undergoing surgical debulking and intraperitoneal chemotherapy. J Clin Oncol. 2003; 21(24):4560-7. DOI: 10.1200/JCO.2003.04.150. View

19.

Dindo D, Demartines N, Clavien P . Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004; 240(2):205-13. PMC: 1360123. DOI: 10.1097/01.sla.0000133083.54934.ae. View

20.

Glehen O, Kwiatkowski F, Sugarbaker P, Elias D, Levine E, de Simone M . Cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for the management of peritoneal carcinomatosis from colorectal cancer: a multi-institutional study. J Clin Oncol. 2004; 22(16):3284-92. DOI: 10.1200/JCO.2004.10.012. View