Phase III randomized controlled trial of hypotonic intraperitoneal cisplatin combined with oral UFT/PSK for the adjuvant treatment of gastric cancer invading the serosa

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4027-4027
Author(s):  
S. Tsujitani ◽  
H. Saito ◽  
S. Tatebe ◽  
M. Ikeguchi
Keyword(s):  
Gastric Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Abdominal Cavity ◽  
Oral Chemotherapy ◽  
Peritoneal Recurrence ◽  
Phase Iii ◽  
Curative Surgery ◽  
Curative Gastrectomy ◽  
Randomized Controlled

4027 Background: Peritoneal seeding is the most common pattern of recurrence in patients with gastric cancer invading the serosa who underwent curative gastrectomy. We developed hypotonic intraperitoneal cisplatin for preventing peritoneal recurrence in experimental models. Hypotonic cisplatin had a significant tumorcidal effect in vitro and in vivo. Hypotonic intraperitoneal cisplatin was tolerable in phase I clinical study. Now, we investigated the efficacy of the treatment in a multicenter prospective randomized controlled trial. Methods: 134 pts treated with curative resection for gastric cancer invading the serosa were randomized during surgery to one of 2 treatment arms. As per protocol, eligibility was confirmed by pathology and treatment course in 108 pts as follows: A -Hypotonic intraperitoneal cisplatin (100mg/m2) during surgery and systemic UFT (300mg/day) + PSK (protein-bound polysaccharide, 3g/day) (n=54) and B-Systemic UFT + PSK (n=48). Cisplatin diluted in 1,000 ml of warmed distilled water was injected to the abdominal cavity before closure of the abdomen. Drains were closed for 1 hour after injection of cisplatin. Results: Median follow up was 6.8 years. Postoperative complication rate and side effects were 21.3% and 30.8% in A-arm and 22.4% and 24.0% in B-arm. Tolerance was good in both arms. Peritoneal recurrence rate was 26.9% in A-arm and 40.0% in B-arm (chi-square p=0.16). Overall survival at 5 years was 62.0% and 31.0% in pts with or without hypotonic intraperitoneal cisplatin (log-rank p=0.03). Conclusions: Combining hypotonic intraperitoneal cisplatin and systemic oral chemotherapy improves the efficacy of oral chemotherapy after curative surgery for gastric cancer invading the serosa. No significant financial relationships to disclose.

Extensive peritoneal lavage after curative gastrectomy for gastric cancer study (EXPEL): An international multicenter randomized controlled trial.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 279-279 ◽  
Author(s):  
Jimmy Bok Yan So ◽  
Jiafu Ji ◽  
Sang Uk Han ◽  
Masanori Terashima ◽  
Guoxin Li ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adverse Events ◽  
Cumulative Incidence ◽  
Peritoneal Lavage ◽  
Controlled Trial ◽  
Peritoneal Recurrence ◽  
Phase Iii ◽  
Rank Test ◽  
Curative Gastrectomy ◽  
Multicenter Randomized Controlled Trial

279 Background: Peritoneal recurrence of gastric cancer after curative surgical resection is common and portends a poor prognosis. Preliminary studies suggest extensive intraoperative peritoneal lavage (EIPL) may reduce the risk of peritoneal recurrence and improve survival. We sought to perform a randomized phase III study to definitively establish the role of performing EIPL after gastrectomy. Methods: This is a prospective, open-label, phase 3 multicentre randomised controlled trial involving 22 hospitals from Korea. China, Japan, Malaysia and Singapore. Patients aged between 21 to 80 years with cT3/4 stomach cancer undergoing curative resection were randomized to either surgery and EIPL (lavage with 10 litres of saline) or surgery alone. Comparison of DFS and OS were made via log-rank test. The cumulative incidence of peritoneal recurrence was compared using competing risks approach. All analyses were performed based on intention-to-treat. Results: Between March 2015 to August 2018, 800 patients were randomly assigned to surgery alone ( n= 402) or EIPL ( n= 398). Based on a median follow-up duration of 29 months, the 3-year cumulative incidence of all-cause mortality was 23.1% and 23.3% for EIPL and surgery alone respectively (hazard ratio [HR] = 1.09, 95% CI: 0.78 to 1.52, p = 0.615). Similarly, the 3-year cumulative incidence of recurrence were 28.0% and 25.9% respectively (HR = 1.01, 95% CI: 0.74 to 1.37, p = 0.947), and 7.9% and 6.6% respectively for peritoneal recurrence (Subdistribution HR = 1.33, 95% CI: 0.73 to 2.42, p = 0.347). Overall, the risk of adverse events was higher in EIPL as compared to surgery alone (relative risk = 1.58, 95% CI 1.07 to 2.33, p = 0.019). The most common adverse events were anastomotic leak, bleeding and intra-abdominal abscess. At the planned third interim analysis on 28 August 2019, the predictive probability of achieving even a 5% difference in 3-year OS in favour of EIPL at final analysis was < 0.4%. The trial was thus recommended to terminate on the basis of futility. Conclusions: EIPL does not show any survival benefit compared with surgery alone and is not recommended for patients undergoing curative gastrectomy for cancer. Clinical trial information: NCT02140034.

scholarly journals Post-hoc biomarker analyses of T4a/T4b gastric cancer from patients recruited into SAMIT, a phase III randomized controlled trial

2021 ◽  
Author(s):  
Takashi Oshima ◽  
Akira Tsuburaya ◽  
Kazuhiro Yoshida ◽  
Takaki Yoshikawa ◽  
Yohei Miyagi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Randomized Controlled Trial ◽  
Adjuvant Chemotherapy ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Phase Iii ◽  
P Value ◽  
Positive Effects ◽  
Randomized Controlled

Abstract Biomarkers for selecting gastric cancer (GC) patients likely to benefit from sequential paclitaxel treatment followed by fluorinated-pyrimidine-based adjuvant chemotherapy were searched for using samples of patients recruited into SAMIT, a phase III randomized controlled trial. Total RNA was extracted from 556 GC patients and the expression of 105 genes were quantified using real-time PCR. Genes predicting positive effects of sequential paclitaxel on overall survival (OS), disease-free survival (DFS), or cumulative incidence of relapse were identified based on p-values associated with the interaction between the biomarker and sequential paclitaxel or monotherapy group. Low VSNL1 and CD44v expression predicted the positive effects of sequential paclitaxel in all above three endpoints. In the patient subgroup with combined low expression of both genes, sequential paclitaxel therapy was associated with a significantly improved OS (hazard ratio [HR] = 0.48 [95% confidence interval (CI), 0.30–0.78]; p < 0.01; interaction p-value < 0.01), particularly in patients with stage IIIB GC (HR = 0.39 [95% CI, 0.20–0.75]; p < 0.01; interaction p-value < 0.01). In this study, two biomarkers were identified. Our findings might open up the way for clinical trials on biomarker-oriented postoperative adjuvant chemotherapy for locally advanced cancer.

scholarly journals Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine Candidate: A Phase III Randomized Controlled Trial in Children

2013 ◽  
Vol 208 (4) ◽  
pp. 544-553 ◽  
Author(s):  
Joanne M. Langley ◽  
Alfonso Carmona Martinez ◽  
Archana Chatterjee ◽  
Scott A. Halperin ◽  
Shelly McNeil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Influenza Vaccine ◽  
Vaccine Candidate ◽  
Controlled Trial ◽  
Phase Iii ◽  
Randomized Controlled ◽  
Quadrivalent Influenza Vaccine
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