A phase II study of modified XP therapy as first line chemotherapy for HER2 negative patient with unresectable or recurrent gastric cancer.

A phase II study of modified XP therapy as first line chemotherapy for HER2 negative patient with unresectable or recurrent gastric cancer. - A phase II study of modified XP therapy as first line chemotherapy for HER2 negative patient with unresectable or recurrent gastric cancer.(KSCC1104)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006668

Enrollment

Registered

2011-11-04

Start date

2011-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Interventions

modified XP therapy capecitabine 2,000mg/m2/day p.o. (day1-14) CDDP 60mg/m2 i.v. (day1) to be repeated every 3 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Written informed consent 2.Appropriate for the study at the physician's assessment 3. Histologically confirmed HER2 negative unresectable or recurrent gastric cancer. 4.No prior chemotherapy for the patients with unresectable or recurrent gastric cancer 5. be able to take oral drugs 6.Aged 20<= years. 7.Life expectancy at least 3 months. 8.At least one measurable lesion based on the RECIST criterion.(within 28 days before registration) 9.ECOG performance status of 0-1. 10.Required baseline laboratory parameters (within 14 days before registration): 1 WBC more than 3000 and WBC less than 12000/mm3 2 Neu more than 1,500/ mm3 3 Plt more than 100,000/ mm3 4 Hb more than 9.0g/dl 5 T-Bil less than 1.5mg/dl 6 AST and ALT <= 100IU/l (200IU/I in case of liver metastasis) 7 Cre < 1.5mg/dl 8 CCr >= 50mL/min 9 HER2 negative

Exclusion criteria

Exclusion criteria: 1.Previously received chemotherapy including a Platinum based regimen 2. Allergy against platinum containing drugs or component of fluoropyrimidine. 3. History of severe adverse event suspected to be caused by dihydropyrimidine dehydrogenase (DPD) deficiency. 4. Relapsed within 6 months after completion of or during adjuvant chemotherapy 5. Prior chemotherapy and radiotherapy followed by primary tumor resection 6. Simultaneous or metachronous double cancers within 5 year. (Carcinoma in situ or intramucosal carcinoma curable with local therapy is excluded for active double cancer.) 7. Active infection and inflammation. 8. Positive for hepatitis B or C virus 9. Heart disease that is serious or requires hospitalization, or history of such disease within past 1 year 10. Severe complications, such as intestinal paralysis, ileus, interstitial lung disease, lung fibrosis,uncontrolled diabetes mellitus, renal failure and hepatocirrhosis. 11. Chronic diarrhea. 12. Active gastrointestinal haemorrhage 13. Body cavity fluids requiring drainage or other treatment 14. Brain or meningeal metastasis. 15. Pregnant or lactating women, and women who are capable of pregnancy or intend to get pregnant 16. No birth-control 17. Treated with antipsychotic drugs, or with mental disorder requiring medication. 18.Not appropriate for the study at the physician's assessment

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression free survival Time to treatment failure Time to failure of strategy Overall survival Safety	—

Countries

Japan

Contacts

Public ContactKSCC

Clinical Research Support Center Kyushu KSCC

kscc2@cres-kyushu.or.jp092-631-2920

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026