Japanease

Oct. 01, 2018

April. 26, 2019

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)
(P-SELECT)

Selection trial of paclitaxel in gastric cancer with peritoneal dissemination (P-SELECT)

Hirata Kenro

Keio University Hospital

35, Shinanomachi, Shinjuku, Tokyo

+81-3-3353-1211

kenro916@gmail.com

Yukawa Naomi

Keio University Hospital

35, Shinanomachi, Shinjuku, Tokyo

+81-3-5363-3288

yukawa703@keio.jp

Oct. 11, 2018

105

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

None

1) age >= 20 years old.
2) Informed consent.
3) Histological diagnosis of primary gastric or esophagogastric junction adenocarcinoma.
4) Unresectable gastric or esophagogastric junction cancer or recurrent gastric or esophagogastric junction cancer.
5) At least one of i) to iv) below present as a sign indicating peritoneal metastasis.
i) Contrast enema/enterography: Obvious malignant intestinal stenosis or deformation of the intestinal wall.
ii) CT: Obvious peritoneal mass or ascites, hydronephrosis not attributable to a cause other than peritoneal metastasis, increased density of peritoneal adipose tissue, thickening of the intestinal wall.
iii) Clinical signs: Palpable metastasis in the pouch of Douglas, board-like rigidity of the abdomen not attributable to a cause other than peritoneal metastasis.
iv) Operative findings (including exploratory laparoscopy): Lesions suggestive of peritoneal metastasis, confirmed by pathological diagnosis of peritoneal metastasis.
6) Patients without massive pleural effusion.
7) Patients without advanced central nervous system (CNS) metastases.
8) Patients with lesions which can be evaluated (Whether or not lesions are measurable is irrelevant.).
9) Intolerant or refractory to first-line therapy including a fluoropyrimidine.
10) Patient without history of use of taxane or angiogenesis inhibitors.
11) Patients without history of radiotherapy including irradiation of the abdominal region.
12) ECOG performance status: 0, 1, 2
13) Adequate organ function.

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.
2) History of sensitivity to any of the drugs used in this study (including alcohol or albumin sensitivity).
3) Patients with the history of surgery under general anesthesia within 28 days.
4) Patients who have had deep vein thrombosis, pulmonary embolism, or some other major form of thromboembolism up to 12 weeks prior to enrollment.
5) Palliative ascites aspiration (excluding diagnostic puncture for laboratory tests) within the past 2 weeks.
6) Active infection requiring systemic treatment.
7) Uncontrolled hypertension despite hypotensive drug therapy.
8) Diabetes under treatment with continuous insulin use or uncontrolled diabetes.
9) Patients with severe pulmonary disease.
10) Unstable angina (attacks occurring or exacerbated within the past 3 weeks), or myocardial infarction within the past 3 months.
11) Serious hemorrhagic disorder or vasculitis, or an episode of serious gastrointestinal bleeding.
12) Grade 2 or worse peripheral sensory neuropathy.
13) Patients with liver cirrhosis (Child Pugh B or C) or previous hepatic encephalopathy.
14) Patients with intestinal obstruction.
15) Patients receiving continuous systemic administration of steroids.
16) Patients receiving antiplatelet drugs.
17) Mental illness or mental symptoms that would interfere with participation in the study.
18) Pregnant, breast-feeding, with chance of pregnancy, or expecting to give birth.
19) Patients deemed by an investigator to be unsuitable as study subjects for any other reason.

20age old over
No limit

Both

Unresectable advanced gastric/esophagogastric junction adenocarcinoma with peritoneal dissemination

Arm A (Standard Treatment)
Paclitaxel 80 mg/m^2 day 1, 8, 15 div
Ramucirumab 8 mg/kg day 1, 15 div
Continued for 4-week courses until the subject becomes refractory.

Arm B (Investigational Treatment)
Nab-paclitaxel 100 mg/m^2 day 1, 8, 15 div
Ramucirumab 8 mg/kg day 1, 15 div
Continued for 4-week courses until the subject becomes refractory.

Overall survival: OS

Progression-free survival: PFS
Objective response rate: ORR
Disease control rate: DCR
Proportion of ascites response
Proportion of ascites control
Time to treatment failure: TTF
Rate of adverse events
Quality of life: QOL
Biomarkers for nab-PTX and RAM

Recruiting

TAIHO PHARMACEUTICAL CO., LTD.
Not applicable
Certified Review Board of Keio
35, Shinanomachi, Shinjuku, Tokyo, Tokyo

+81-3-5363-3503

med-nintei-jimu@adst.keio.ac.jp
Approval

Aug. 09, 2018

なし
None