UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022450 |
|---|---|
| Receipt number | R000025874 |
| Scientific Title | Phase II study of Capecitabine + oxaliplatin(CapeOx) for elderly patients with untreated metastatic gastric cancer <TCOG GI-1601> |
| Date of disclosure of the study information | 2016/05/25 |
| Last modified on | 2023/01/11 10:25:48 |
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Basic information
Public title
Phase II study of Capecitabine + oxaliplatin(CapeOx) for elderly patients with untreated metastatic gastric cancer
<TCOG GI-1601>
Acronym
Phase II study of Capecitabine + oxaliplatin(CapeOx) for elderly patients with untreated metastatic gastric cancer
<TCOG GI-1601>
Scientific Title
Phase II study of Capecitabine + oxaliplatin(CapeOx) for elderly patients with untreated metastatic gastric cancer
<TCOG GI-1601>
Scientific Title:Acronym
Phase II study of Capecitabine + oxaliplatin(CapeOx) for elderly patients with untreated metastatic gastric cancer
<TCOG GI-1601>
Region
| Japan |
Condition
Condition
Untreated metastatic gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of capecitabine plus oxaliplatin (CapeOX) for elderly patients with untreated metastatic gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression-free survival
Time to treatment failure
Response rate
Relative dose intensity
Incidence of adverse events
Geriatric Assessment
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
CapeOX (oxaliplatin; 100 mg/m2 [day 1], capecitabine; 1,500 mg/m2/day [day1-day15]):
The treatment will be repeated every 3 weeks, unless the disease progression, unacceptable toxicity, tumor resection, or consent withdrawal
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed gastric adenocarcinoma, signet-ring cell, mucinous, or hepatoid
2) HER2 negative or unknown
3) Metastatic
4) Adequate oral intake
5) Evaluable leision by RECIST Ver.1.1
6) Surgical history:
Interval over 4w from abdominal surgery, over 2w from palliative surgery or non-curative resection
7) No prior treatment of chemotherapy, radiation therapy, or immunotherapy:
excluding recurrence at least 6 months after completion of post-operative adjuvant chemotherapy not containing oxliplatin
8) Aged 70 years and over
9) Performance Status(ECOG) 0 or 1
10) Patients who are expected to survive more than 3 months
11) Adequate organ function:
i) Hb>= 8.0 g/dL
ii) WBC<= 12,000/mm3
iii) Neutrophil>= 1,500/mm3
iv) Platelet>= 100,000/mm3
v) Total bilirubin<= 1.5 mg/dL
vi) AST<= 100 IU/L (within less
than 5 times of UNL in patients with liver metastasis)
vii) ALT<= 100 IU/L (within less
than 5 times of UNL in patients with liver metastasis)
viii) Serum creatinine<= 1.50mg/dL
ix) Ccr>= 50 mL/min
12) Written informed consent
Key exclusion criteria
1) Blood transfusion, blood products or G-CSF within 21 days at registration
2) Peripheral sensory neuropathy: Grade 1 or greater
3) Uncontrolled hypertension or diabetes; interstitial pneumonia, pulmonary fibrosis, or severe emphysema; renal failure, hepatic failure, active gastrointestinal bleeding, stroke in 3 months
4) Abnormal electrocardiogram
5) More than moderate dose of ascites, massive pleural effusion
6) Brain metastasis
7) Extensive bone metastasis
8) Multiple primary cancers
9) HBs antigen positive, HCV or HIV antibody positive
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Kensei |
| Middle name | |
| Last name | Yamaguchi |
Organization
The Cancer Institute Hospital of JFCR
Division name
Gastroenterological Chemotherapy
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
03-3520-0111
kensei.yamaguchi@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Masuda |
Organization
The Tokyo Cooperative Oncology Group
Division name
CapeOX affairs office
Zip code
105-0013
Address
Toa BLDG.4F, 2-1-18, Hamamatsu-cho, Minato-ku, Tokyo, Japan
TEL
03-5401-5020
Homepage URL
capeox@tcog.jp
Sponsor or person
Institute
The Tokyo Cooperative Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha 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
Wakayama Medical University Certified Review Board
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture, Japan
Tel
073-441-0896
wa-rinri@wakayama-med.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 18 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 29 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 25 | Day |
Last modified on
| 2023 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025874
