UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000008053