scholarly journals Can Gastric Cancer Patients be Successfully Recruited for Clinical Phase III/IV and Health Outcome Studies Using Managed Physician Panels?

2014 ◽  
Vol 17 (7) ◽  
pp. A544
Author(s):  
F. Eichmann ◽  
P. Potthoff ◽  
C. Brown
Keyword(s):  
Gastric Cancer ◽  
Health Outcome ◽  
Cancer Patients ◽  
Outcome Studies ◽  
Phase Iii ◽  
Clinical Phase ◽  
Gastric Cancer Patients

Phase II study of intraperitoneal paclitaxel combined with S-1 plus cisplatin for gastric cancer with peritoneal metastasis: SP + IP PTX trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4529-4529
Author(s):  
Daisuke Kobayashi ◽  
Ryoji Fukushima ◽  
Mitsuhiko Ota ◽  
Sachio Fushida ◽  
Naoyuki Yamashita ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Peritoneal Metastasis ◽  
Response Rate ◽  
Phase Iii ◽  
Peritoneal Cytology ◽  
Response To Chemotherapy ◽  
Grade 3 ◽  
Gastric Cancer Patients

4529 Background: Intraperitoneal (IP) chemotherapy is a promising treatment option for gastric cancer with peritoneal metastasis. Although a phase III study failed to show a statistically significant superiority of IP paclitaxel (PTX) combined with S-1 and intravenous PTX over S-1/cisplatin (SP), the standard of care as a first-line treatment in Japan, the sensitivity analysis suggested clinical efficacy of the IP PTX. Thus, attempts to combine IP PTX with other systemic therapies with higher efficacy have been warranted. After a dose-finding study, we sought to explore efficacy of a new regimen that combined IP PTX with SP. Methods: Gastric cancer patients with peritoneal metastasis confirmed by diagnostic imaging, laparoscopy or laparotomy were enrolled in the phase II multi-institutional prospective trial. In addition to the established SP regimen (S-1 administered orally at a dose of 80 mg/m2 bid for 21 days followed by a 14-day rest and cisplatin administered intravenously at a dose of 60 mg/m2 on day 8), IP PTX was administered on days 1, 8 and 22 at a dose of 20 mg/m2. The primary endpoint is overall survival (OS) rate at one year after treatment initiation. Secondary endpoints are progression free survival (PFS), response rate and toxicity. Results: Fifty-three patients were enrolled and fully evaluated for OS and toxicity. The median number of courses was 7 (range 1-20). The 1-year OS rate was 74% (95% CI, 60-83%). The median survival time was 19.4 months (95% CI, 16.7 months-). The 1-year PFS rate was 57% (95% CI, 42-69%). The overall response rate was 20% (95% CI, 1-72%) in 5 patients with target lesions. Cancer cells ceased to be detected by peritoneal cytology in 23 (64%) of 36 patients. Fourteen (26%) patients underwent gastrectomy after response to chemotherapy. The incidences of grade 3/4 hematological and non-hematological toxicities were 43% and 47%, respectively. The frequent grade 3/4 toxicities included neutropenia (23%), anemia (29%), diarrhea (13%) and anorexia (17%). Intraperitoneal catheter and implanted port-related complications were observed in 4 patients. There was 1 treatment-related death. Conclusions: IP PTX combined with SP is well tolerated and active in gastric cancer patients with peritoneal metastasis. Clinical trial information: UMIN000023000 .

Phase III study of intraperitoneal paclitaxel plus s-1/paclitaxel compared with s-1/cisplatin in gastric cancer patients with peritoneal metastasis: PHOENIX-GC trial.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 4014-4014 ◽  
Author(s):  
Hironori Ishigami ◽  
Yoshiyuki Fujiwara ◽  
Ryoji Fukushima ◽  
Atsushi Nashimoto ◽  
Hiroshi Yabusaki ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Cancer Patients ◽  
Peritoneal Metastasis ◽  
Phase Iii ◽  
Phase Iii Study ◽  
Gastric Cancer Patients

Phase III Study of Docetaxel and Cisplatin Plus Fluorouracil Compared With Cisplatin and Fluorouracil As First-Line Therapy for Advanced Gastric Cancer: A Report of the V325 Study Group

2006 ◽  
Vol 24 (31) ◽  
pp. 4991-4997 ◽  
Author(s):  
Eric Van Cutsem ◽  
Vladimir M. Moiseyenko ◽  
Sergei Tjulandin ◽  
Alejandro Majlis ◽  
Manuel Constenla ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Risk Reduction ◽  
Cancer Patients ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Iii ◽  
First Line Therapy ◽  
Grade 3 ◽  
Gastric Cancer Patients

Purpose In the randomized, multinational phase II/III trial (V325) of untreated advanced gastric cancer patients, the phase II part selected docetaxel, cisplatin, and fluorouracil (DCF) over docetaxel and cisplatin for comparison against cisplatin and fluorouracil (CF; reference regimen) in the phase III part. Patients and Methods Advanced gastric cancer patients were randomly assigned to docetaxel 75 mg/m2 and cisplatin 75 mg/m2 (day 1) plus fluorouracil 750 mg/m2/d (days 1 to 5) every 3 weeks or cisplatin 100 mg/m2 (day 1) plus fluorouracil 1,000 mg/m2/d (days 1 to 5) every 4 weeks. The primary end point was time-to-progression (TTP). Results In 445 randomly assigned and treated patients (DCF = 221; CF = 224), TTP was longer with DCF versus CF (32% risk reduction; log-rank P < .001). Overall survival was longer with DCF versus CF (23% risk reduction; log-rank P = .02). Two-year survival rate was 18% with DCF and 9% with CF. Overall response rate was higher with DCF (χ2 P = .01). Grade 3 to 4 treatment-related adverse events occurred in 69% (DCF) v 59% (CF) of patients. Frequent grade 3 to 4 toxicities for DCF v CF were: neutropenia (82% v 57%), stomatitis (21% v 27%), diarrhea (19% v 8%), lethargy (19% v 14%). Complicated neutropenia was more frequent with DCF than CF (29% v 12%). Conclusion Adding docetaxel to CF significantly improved TTP, survival, and response rate in gastric cancer patients, but resulted in some increase in toxicity. Incorporation of docetaxel, as in DCF or with other active drug(s), is a new therapy option for patients with untreated advanced gastric cancer.

Randomized, multicenter, controlled evaluation of S-1 and oxaliplatin (SOX regimen) as neoadjuvant chemotherapy for advanced gastric cancer patients (RESONANCE trial).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 90-90
Author(s):  
Tao Li ◽  
Lin Chen
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Preoperative Chemotherapy ◽  
Stage Ii ◽  
Phase Iii ◽  
D2 Lymphadenectomy ◽  
D2 Surgery ◽  
Gastric Cancer Patients

90 Background: RESONANCE trial aims to improve 3-year disease-free survival (DFS) for patients treated with neoadjuvant chemotherapy and D2 surgery with chemotherapy postoperatively. We also evaluated the postoperative complications with and without preoperative chemotherapy to reveal the safety of SOX regimen. Methods: In this phase III multicenter study, patients with American Joint Committee on Cancer(AJCC,7thed)stage II-IIII advanced gastric cancer are treated with two to four cycles of preoperative SOX chemotherapy, followed by gastrectomy with D2 lymphadenectomy, and then another four to six postoperative cycles of SOX chemotherapy. Surgical and pathological quality control is performed. The primary endpoint is 3-year DFS, secondary endpoints are 3-year OS, D2/R0 rate, and toxicity and recurrence risk. The RESONANCE trial has been registered internationally, and twenty hospitals have participated in this trial. Results: Between February 2012 and to August 2013, 128 patients were enrolled in the neoadjuvant group , 103 patients were enrolled in the adjuvant group. Seventy-four of 128 patients underwent gastrectomy with D2 lymphadenectomy after preoperative chemotherapy. In these 74 patients, 52 (70%) patients had clinical tumor response and 10 (14%) patients achieved histological response. Operative mortality was never encountered. R0 resection rate was 90.5% after neoadjuvant chemotherapy compared with 94.2% in adjuvant group (p=0.23). Postoperative complication rates in neoadjuvant and adjuvant groups were 33.8% and 37.9% respectively (p=0.58). Conclusions: Results of this study will demonstrate whether neoadjuvant chemotherapy strategy will be superior to adjuvant chemotherapy when combined with D2 surgery for AJCC stage II-III gastric cancer patients. Furthermore, it might be an important clinical evidence to verify benefit of neoadjuvant chemotherapy in advanced gastric cancer. Clinical trial information: NCT01583361.

Sign in / Sign up

Export Citation Format

Share Document