UMIN-CTR Clinical Trial

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

HER2 negative gastric cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Median progression free survival (PFS)

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

12

Month

01

Day

URL releasing protocol

http://www.t-core.jp/

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

11

Month

30

Day

Last modified on

2020

Year

07

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008053