UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012701 |
|---|---|
| Receipt number | R000014802 |
| Scientific Title | A phase II study of nab-Paclitaxel therapy in reductive dose for patients with advanced/recurrent gastric cancer after prior treatments including fluoropyrimidine (OGSG 1302) |
| Date of disclosure of the study information | 2013/12/28 |
| Last modified on | 2022/09/25 20:44:51 |
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Basic information
Public title
A phase II study of nab-Paclitaxel therapy in reductive dose for patients with advanced/recurrent gastric cancer after prior treatments including fluoropyrimidine (OGSG 1302)
Acronym
A phase II study of nab-Paclitaxel therapy in reductive dose for patients with advanced/recurrent gastric cancer after prior treatments including fluoropyrimidine (OGSG 1302)
Scientific Title
A phase II study of nab-Paclitaxel therapy in reductive dose for patients with advanced/recurrent gastric cancer after prior treatments including fluoropyrimidine (OGSG 1302)
Scientific Title:Acronym
A phase II study of nab-Paclitaxel therapy in reductive dose for patients with advanced/recurrent gastric cancer after prior treatments including fluoropyrimidine (OGSG 1302)
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy and safety of nab-Paclitaxel therapy in reductive dose (220mg/m2)for patients with advanced/recurrent gastric cancer after prior treatments including fluoropyrimidine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Overall survival rate
Progression free survival rate
Time to treatment failure
Disease control rate
Incidence and Grade of Adverse Events
Relative Performance
Rate of Patients who receive next treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment should be started within 2 weeks of registration
Nab-paclitaxel (220mg/m2) is administered intravenously in 30 minutes once 21 days. When neutrophil keeps more than 1500/mm3, the dose of Nab-paclitaxel will be escalated to 260mg.m2.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven gastric adenocarcinoma including esophago-gastric injection cancer
2) Patient with adevanced/recurrent gastric cancer which are resistant to chemotherapy including fluoropyrimydine. Patient with HER2 positive have to use trastuzumab in combination with fluoropyrimydine.
3) Older than 20 years
4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
5) With mesurable lesions by RECIST version 1.1
6) Without prior therapy of paclitaxel
7) With good functions of important organs
a) WBC : =< 12,000/mm3
b) Neutrophil : => 2,000/mm3
c) Platelet : => 100,000/mm3
d) Hemoglobin : => 9.0g/dL
e) Total bilirubin : =< 1.5mg/dL
f) AST, ALT : =< 100IU/L, or =< 200IU/L for patients with liver metastasis
g) Creatinine : =< 1.5mg/dL
8) With longer than 90 days of expected survival at the registration
9) With written Informed Consent
Key exclusion criteria
1)with a history of severe allergy against medicine
2)with infectious disease and febrile condition (over 38 centigrade)
3)with severe diseases: interstitial pneumonitis/pulmonary fibrosis, uncontrolled DM, renal failure, and/or liver failure
4)with uncontrollable diarrhea (more than 4 times a day)
5)with a history or present heart diseases (congestive heart failure, cardiac infarction/ischemic heart disease, arrhythmia, valve dysfunction)
6)with active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval period
7)with peripheral nerve disorder severer than grade 2
8)patients who are suspected incompletion of regimen due to psychological disease
9) pregnant or nursing female or male expecting pregnancy of partner
10) with brain metastasis
11) with HBs antigen+, and/or HCV-antibody+
12) Any other patients whom the physician in charge of the study judges to be unsuitable
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeyuki Tamura |
Organization
YAO Municipal Hospital
Division name
Department of Surgery
Zip code
Address
1-3-1,Ryugecho,Yao-city,Osaka,581-0069,JAPAN
TEL
072-922-0881
stamura@kanrou.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirokazu Taniguchi |
Organization
Minoh City Hospital
Division name
Department of Surgery
Zip code
Address
5-7-1, Kayano, Minoh-shi, Osaka, 562-0014, Japan
TEL
072-728-2001
Homepage URL
htaniguchi@maia.eonet.ne.jp
Sponsor or person
Institute
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department
Personal name
Funding Source
Organization
TAIHO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
関西労災病院（兵庫県）、NTT西日本大阪病院（大阪府）、八尾市立病院（大阪府）、星ヶ丘医療センター（大阪府）、堺市立総合医療センター（大阪府）、市立貝塚病院（大阪府）、県立西宮病院（兵庫県）、市立豊中病院（大阪府）大阪医療センター（大阪府）、大阪労災病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 28 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007%2Fs10147-020-01768-w
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs10147-020-01768-w
Number of participants that the trial has enrolled
33
Results
The response rate (RR) was 3.1% [95% confidence interval (CI), 0-16.2%], which did not reach the protocol-specified threshold (p=0.96). disease-control rate (DCR) was 37.5% (95% CI, 21.1-56.3%). Median overall survival (OS) and progression-free survival (PFS) were 6.3 (95% CI, 4.4-14.2) and 2.2 (95% CI, 1.8-3.1) months, respectively. Relative dose intensity (RDI) was 97.8%. Twenty (62.5%) patients received subsequent chemotherapy.
Results date posted
| 2022 | Year | 09 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 09 | Month | 14 | Day |
Baseline Characteristics
Eligible patients included those with AGC and ECOG performance status of 0-2 who had received one or more prior chemotherapy containing fluoropyrimidine regimens.
Participant flow
Among 33 patients enrolled, 32 were treated with protocol therapy.
Adverse events
Toxicity was relatively mild with the most common grade >= 3 adverse events being neutropenia (38%), anemia (13%), fatigue (19%), anorexia (16%), and peripheral neuropathy (13%).
Outcome measures
The response rate (RR) was 3.1% [95% confidence interval (CI), 0-16.2%], which did not reach the protocol-specified threshold (p=0.96). disease-control rate (DCR) was 37.5% (95% CI, 21.1-56.3%). Median overall survival (OS) and progression-free survival (PFS) were 6.3 (95% CI, 4.4-14.2) and 2.2 (95% CI, 1.8-3.1) months, respectively. Relative dose intensity (RDI) was 97.8%. Twenty (62.5%) patients received subsequent chemotherapy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 25 | Day |
Last modified on
| 2022 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014802
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