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)

Phase 2

• Conditions: HER2 negative gastric cancer

• Registration Number: JPRN-jRCTs021180013
• Lead Sponsor: Takahashi Masanobu

Brief Summary

The primary endpoint was not met. It could not be concluded that capecitabine plus cisplatin therapy was an effective regimen in patients with recurrent HER2-negative gastric cancer who had been treated with and refractory to S-1 adjuvant therapy.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-11-30
• Study Start: 2019-03-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 21

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFS; Progression-Free Survival

Secondary Outcome Measures

Name	Time	Method
OS; Overall Survival, TTF; Time to Treatment Failure, ORR; Overall Response Rate,Adverse events