Introduction
Gastric cancer, a leading cause of cancer mortality worldwide, presents unique challenges when it metastasizes to the peritoneum. Standard treatments have long been limited to palliative systemic chemotherapy, offering modest hope for those afflicted. However, a groundbreaking clinical trial in the Netherlands, known as PERISCOPE II, suggests a new horizon for patients suffering from this pernicious disease. This trial explores the efficacy of combining cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) following neoadjuvant systemic chemotherapy, potentially revolutionizing the treatment paradigm for gastric cancer patients with peritoneal dissemination.
Keywords
1. Gastric cancer treatment
2. Cytoreductive surgery
3. Hyperthermic intraperitoneal chemotherapy
4. Peritoneal metastasis
5. Clinical trial for stomach cancer
The Study Protocol
According to the study protocol published in BMC Cancer (DOI: 10.1186/s12885-019-5640-2), the PERISCOPE II trial is a multicentre randomised controlled phase III trial designed to compare the overall survival rates of gastric cancer patients with peritoneal dissemination treated with the conventional palliative systemic chemotherapy versus those who undergo CRS and HIPEC after initial systemic chemotherapy. The primary focus of the procedure is the targeted elimination of microscopic disease residues that are often the culprits of cancer recurrence.
Criteria for Inclusion
To be eligible for enrollment, patients must have a resectable cT3-cT4 primary gastric tumor with regional lymph node involvement, confirmed limited peritoneal dissemination (Peritoneal Cancer Index < 7), and/or positive peritoneal cytology, established by laparoscopy or laparotomy, and no progression of disease after systemic chemotherapy. A total of 106 patients will be randomized (1:1) between the standard and experimental treatments, with the first phase of enrolment beginning November 2017 and the expected end date of the trial set for December 2022.
Critical Findings and Potential Impact
While the trial is ongoing, the potential impact of the results from the PERISCOPE II study could significantly alter the trajectory of gastric cancer care, particularly for those patients with peritoneal dissemination. In Asian populations, similar treatment approaches have yielded promising results, but until now, such methods have not been systematically explored in Western patients.
Historical Perspective on Peritoneal Metastasis
Traditional clinical management of peritoneal metastasis from gastric cancer has been largely ineffective, with survival rates remaining low, as noted by Thomassen et al. (2014). Similar sentiment is echoed in research published by Klaver et al. (2012) where palliative chemotherapy was the mainstay approach. The PERISCOPE II trial, however, represents a paradigm shift, potentially offering a more curative approach by direct delivery of cytotoxic drugs to the peritoneal cavity, as illustrated by the work of Elias et al. (2002) and Urano (1999).
Comparison to Existing Research
Existing studies have focused predominantly on systemic chemotherapy, such as those by Franko et al. (2012) and Chau et al. (2004), with limited exploration into enhanced locoregional treatments like CRS and HIPEC. The PERISCOPE II study fundamentally diverges from this model, investigating the synergy between local and systemic treatments.
Implications for Patient Outcomes
If the trial results favour the experimental approach, this could set a new standard of care for patients with gastric cancer peritoneal metastasis, potentially improving survival rates and the quality of life. It could also encourage the reassessment of strategies for similar malignancies with peritoneal involvement.
Ethical Considerations and Trial Transparency
The study is conducted in full compliance with the Declaration of Helsinki, with approval from the medical ethical committee of the Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital. Patients provide informed consent before enrolment, ensuring transparency and ethical accountability.
The Future of Peritoneal Dissemination Treatment
Looking forward, the outcomes of PERISCOPE II may inform future clinical practices and prompt the development of additional trials to refine and enhance treatment protocols for gastric cancer patients with peritoneal dissemination.
Conclusion
The navigation through the complex waters of gastric cancer treatment is on the cusp of being charted in new, potentially life-saving directions. With the ongoing PERISCOPE II trial, healthcare professionals and patients alike wait with bated breath for the results that may herald a new dawn in the battle against gastric cancer’s peritoneal dissemination. Gastric cancer may yet face a formidable opponent in the combination of CRS and HIPEC, offering renewed hope where once there was little.
References
1. Thomassen, I., van Gestel, Y. R., van Ramshorst, B., Luyer, M. D., Bosscha, K., Nienhuijs, S. W., … & de Hingh, I. H. (2014). Peritoneal carcinomatosis of gastric origin: a population-based study on incidence, survival and risk factors. International Journal of Cancer, 134(3), 622-628. DOI: 10.1002/ijc.28373.
2. Klaver, Y. L., Simkens, L. H., Lemmens, V. E., Koopman, M., Teerenstra, S., Bleichrodt, R. P., … & Punt, C. J. (2012). Outcomes of colorectal cancer patients with peritoneal carcinomatosis treated with chemotherapy with and without targeted therapy. European Journal of Surgical Oncology, 38(7), 617-623. DOI: 10.1016/j.ejso.2012.03.008.
3. Elias, D., Bonnay, M., Puizillou, J. M., Antoun, S., Demirdjian, S., El Otmany, A., … & Ducreux, M. (2002). Heated intra-operative intraperitoneal oxaliplatin after complete resection of peritoneal carcinomatosis: pharmacokinetics and tissue distribution. Annals of Oncology, 13(2), 267-272. DOI: 10.1093/annonc/mdf019.
4. Franko, J., Shi, Q., Goldman, C. D., Pockaj, B. A., Nelson, G. D., Goldberg, R. M., … & Alberts, S. R. (2012). Treatment of colorectal peritoneal carcinomatosis with systemic chemotherapy: a pooled analysis of north central cancer treatment group phase III trials N9741 and N9841. Journal of Clinical Oncology, 30(3), 263-267. DOI: 10.1200/JCO.2011.37.1039.
5. Chau, I., Norman, A. R., Cunningham, D., Waters, J. S., Oates, J., & Ross, P. J. (2004). Multivariate prognostic factor analysis in locally advanced and metastatic esophago-gastric cancer–pooled analysis from three multicenter, randomized, controlled trials using individual patient data. Journal of Clinical Oncology, 22(12), 2395-2403. DOI: 10.1200/JCO.2004.08.154.
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