Oct. 01, 2018 |
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April. 01, 2023 |
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jRCTs031180022 |
WJOG10617G Randomized phase II trial of weekly paclitaxel + ramucirumab versus weekly nab-paclitaxel + ramucirumab for unresectable advanced or recurrent gastric/esophagogastric junction adenocarcinoma with peritoneal dissemination refractory to first-line therapy including a fluoropyrimidine (P-SELECT) |
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Selection trial of paclitaxel in gastric cancer with peritoneal dissemination (P-SELECT) |
Jan. 27, 2021 |
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105 |
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Fifty-three patients were assigned to Arm A (weekly PTX plus ramucirumab) and 52 to Arm B (weekly nab-PTX plus ramucirumab). Median age was 69 years in Arm A and 66 years in Arm B. The male ratio was 60.4% in Arm A and 65.4% in Arm B. All patients had peritoneal dissemination, with none/small/moderate/large ascites in 22.6%/41.5%/7.5%/28.3% of patients in Arm A and 23.1%/36.5%/21.2%/19.2% of patients in Arm B. The Lauren classification of intestinal type was 35.8% in Arm A and 34.6% in Arm B, and diffuse type was 62.3% in Arm A and 65.4% in Arm B. |
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Enrollment began on October 2, 2018, and although the initial plan was for a three-year enrollment period, the pace of enrollment exceeded expectations. The last patient was enrolled on January 27, 2020, completing enrollment of 105 cases in 1 year and 4 months. Fifty-eight facilities participated in the study, 30 of which registered at least one case. The top 5 registered centers were Keio University Hospital (13 cases), National Cancer Center Hospital (11 cases), Saitama Cancer Center (10 cases), Toranomon Hospital (8 cases), and Kobe City Medical Center General Hospital (6 cases); the remaining centers registered 5 or fewer cases. Efficacy analysis was performed by ITT analysis. Safety analysis was performed on all patients in group A and 51 patients in group B except one who did not receive protocol treatment. |
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Adverse events were evaluated based on CTCAE version 4.0. One case of treatment-related death (TRD) was observed, which was a case of gastrointestinal perforation from colorectal ileus due to progression of the primary disease, and a causal relationship with ramucirumab could not be ruled out. There were 52 serious adverse events reported, all of which were unrelated or known adverse events. 62.3% of patients in Arm A and 78.4% in Arm B had Grade 3 or higher neutropenia, while 11.3% of patients in Arm A and 5.9% of patients in Arm B had Grade 3 or higher febrile neutropenia. Other G3 or higher adverse events in Arm A and B included anorexia in 13.2% and 15.7% of patients; peripheral sensory neuropathy in 7.5% and 17.6%; and hypertension in 5.7% and 7.8%, respectively. |
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Median OS was 8.1 months in Arm A and 7.2 months in Arm B (HR 1.04, 95% confidence interval [CI] 0.67 - 1.61, P = 0.63). Median PFS was 5.1 months in Arm A and 3.9 months in Arm B (HR 1.04, 95% CI 0.69 - 1.56, P = 0.89). The ORR and DCR for Arm A and Arm B were 20.7% vs. 20.0% (P = 0.99) and 77.4% vs. 63.5% (P = 0.15), respectively. The ascites control rate was 86.1% in Arm A and 70.3% in Arm B (P = 0.07). The incidence of grade 3/4 neuropathy was higher in Arm B (7.5% vs 17.6%, P = 0.14), whereas there was no difference in neuropathy-specific quality of life between the two groups. The incidence of febrile neutropenia was higher in Arm A (11.3% vs 5.9%, P = 0.49). SPARC expression in tumor tissue was not significantly correlated with efficacy, while caveolin-1 expression in tumor stroma was significantly correlated with efficacy in Arm B. Trough values of blood ramucirumab levels tended to correlate with efficacy in Arm A, but not in Arm B. |
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The potential difference in efficacies between nab-PTX+RAM and PTX-RAM was not shown in advanced gastric cancer with peritoneal dissemination. |
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April. 01, 2023 |
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Feb. 01, 2022 |
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https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.4_suppl.280 |
No |
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- |
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https://jrct.niph.go.jp/latest-detail/jRCTs031180022 |
Hirata Kenro |
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Keio University Hospital |
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35, Shinanomachi, Shinjuku, Tokyo |
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+81-3-3353-1211 |
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kenro916@gmail.com |
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Yukawa Naomi |
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Keio University Hospital |
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35, Shinanomachi, Shinjuku, Tokyo |
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+81-3-5363-3288 |
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yukawa703@keio.jp |
Complete |
Oct. 01, 2018 |
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Oct. 11, 2018 | ||
105 | ||
Interventional |
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randomized controlled trial |
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open(masking not used) |
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active control |
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parallel assignment |
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treatment purpose |
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1) age >= 20 years old. |
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1) Active multiple cancer (synchronous multiple cancer or metachronous multiple cancer in which the patient has been disease-free for less than 3 years). However, lesions corresponding to carcinoma in situ (intraepithelial carcinoma) or intramucosal cancer assessed as cured by local treatment are not classed as active multiple cancers. |
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20age old over | ||
No limit | ||
Both |
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Unresectable advanced gastric/esophagogastric junction adenocarcinoma with peritoneal dissemination |
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Arm A (Standard Treatment) |
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Overall survival: OS |
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Progression-free survival: PFS |
TAIHO PHARMACEUTICAL CO., LTD. | |
Not applicable |
Certified Review Board of Keio | |
35, Shinanomachi, Shinjuku, Tokyo, Tokyo | |
+81-3-5363-3503 |
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med-nintei-jimu@adst.keio.ac.jp | |
Approval | |
Aug. 09, 2018 |
なし | |
None |
None |