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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006804
Receipt No. R000008053
Scientific Title PhaseII trial of capecitabine plus cisplatin in patients with recurrent HER-2 negative gastric cancer during or after the adjuvant chemotherapy using S-1 (T-CORE1102)
Date of disclosure of the study information 2011/12/01
Last modified on 2020/07/07

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Basic information
Public title PhaseII trial of capecitabine plus cisplatin in patients with recurrent HER-2 negative gastric cancer during or after the adjuvant chemotherapy using S-1 (T-CORE1102)
Acronym PhaseII trial of capecitabine plus cisplatin for recurrence of HER2 negative cancer patients after S-1 adjuvant chemotherapy (T-CORE1102)
Scientific Title PhaseII trial of capecitabine plus cisplatin in patients with recurrent HER-2 negative gastric cancer during or after the adjuvant chemotherapy using S-1 (T-CORE1102)
Scientific Title:Acronym PhaseII trial of capecitabine plus cisplatin for recurrence of HER2 negative cancer patients after S-1 adjuvant chemotherapy (T-CORE1102)
Region
Japan

Condition
Condition HER2 negative gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Primary endpoint is to evaluate median progression free survival (PFS) of capecitabine plus cisplatin in patients with recurrent HER-2 negative gastric cancer during or after the adjuvant chemotherapy using S-1 . Secondary endpoint is to estimate overall survival (OS), time to treatment failure (TTF), overall response rate (ORR), and frequency of adverse effects. PFS, OS, TTF, ORR and frequency of adverse events before or after a certain period from the end of adjuvant chemotherapy to the recurrence (six months more or less) are also confirmed.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Median progression free survival (PFS)
Key secondary outcomes

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 Cisplatin 80 mg/m2 is given as 2 hours intravenous infusion on day1 with the adequate hydration. Capecitabine is administrated orally twice daily. The dosage of capecitabine is as follows: body surface area (BSA) < 1.36 m2, 2,400 mg/day; 1.36 m2 <= BSA < 1.66 m2, 3,000 mg/day; 1.66 m2 <= BSA< 1.96 m2, 3,600 mg/day; 1.96 m2 <= BSA, 4,200mg from day 1 to day 14. The treatment was continued every 3 weeks until the discontinuation criteria were met.
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) Patient has pathologically comformed gastric adenocarcinoma.
2) HER2 negative (HER2 positive is defined as HER2 (3+) by IHC or HER2 (2+) and FISH positive. HER2 negative is defined as excluding HER2 positive)
3) Recurrence is confirmed by CT or MRI before registration within 28 days.
4) No prior chemothrapy or radiotherapy for recurrent gastric cancer.
5) No neoadjuvant treatment (chemotherapy and or radiotherapy).
6) An Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1
7) R0 resection was carried out and S-1 was administrated asadjuvant chemotherapy.
8) Recurrence is confirmed after or during S-1 treatment for more than 6 months.
9) Oral intakes are possible.
10) Life expectancy of at least 3 monts.
11) Provision of written imformed concent in accordance with govement and institutional guidelines.
12) Age 20 or older.
13) Patient judged eligible for this protocol by the attending physician. .
14) Adequate organ function defined by the following data within 14 days before registration:
1.WBC: 3,000/mm3 or more
2.Neutrophiles: 1,500/mm3 or more
3.Platelets: 100,000/mm3 or more
4.Hb: 8.0 g/dl or more
5.AST(GOT) and ALT(GPT): 100 IU/L or less (in case with metastatic liver tumor, 200 IU/L or less)
6.total bilirubin: less than 2.0 mg/dl
7.creatinine clearance: more than 60ml/minby the actual measurement or the calculation of Cockcroft-Gault
Key exclusion criteria Exclusion criteria were as follows:
1) Cy1.
2) Patients who have been treated with platinum preaviously.
3) A history of drug sensitivity to fluoropyrimidine or platinum
4) Active double cancer within 5 years (except carcinoma in situ and skin cancer which were cured)
5) Active infection or inflammation (fever with 38.0 degree or higher)
6) Active hepatitis
7) Severe heart disease or that history within 1 year.
8) Patient with serious complications such as gastrointestinal paralysis, ileus, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetis mellitis, renal failure, liver damage, and liver cirrhosis.
9) Patient who needs treatments of phenytoin or warfarin.
10) Chronic diarrhea (diarrhea of more than 4 times daily, or watery diarrhea)
11) Active GI tract bleeding.
12) Patient who need drainage of peritoneal, pleural or pericardial effusion.
13) Clinically suspicious of brain metastasis, or that history.
14) Pregnancy, possible pregnancy or lactation.
15) Men who wish their partner to become pregnant
16) Treatment or that previous history of psychiatric diseases.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Chikashi
Middle name
Last name Ishioka
Organization Institute of Development, Aging and Cancer, Tohoku University
Division name Department of Clinical Oncology
Zip code 980-8575
Address 4-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-8543
Email chikashi@tohoku.ac.jp

Public contact
Name of contact person
1st name Masanobu
Middle name
Last name Takahashi
Organization Tohoku Clinical Oncology Research and Education Society (T-CORE)
Division name Administration Office
Zip code 980-8575
Address 4-1 Seiryo-machi, Aoba-ku, Sendai,9808575, Japan
TEL 022-717-8599
Homepage URL http://www.t-core.jp/
Email tcore-admin@umin.ac.jp

Sponsor
Institute Tohoku Clinical Oncoogy, Research and Education Society(T-CORE)
Institute
Department

Funding Source
Organization Tohoku Clinical Oncoogy, Research and Education Society(T-CORE)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization MHLW Certified Clinical Research Review Board, Tohoku University
Address 2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan
Tel 022-718-0461
Email office@nrs.hosp.tohoku.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
2011 Year 12 Month 01 Day

Related information
URL releasing protocol http://www.t-core.jp/
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 21
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
2011 Year 12 Month 01 Day
Date of IRB
2011 Year 12 Month 16 Day
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 30 Day
Last modified on
2020 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008053

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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