XParTS: Capecitabine/Cisplatin(XP) for Recurrent Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Phase II Study to Evaluate Efficacy and Safety of Capecitabine/Cisplatin Combination Therapy in Gastric Cancer Patients Who Relapsed After S-1 Adjuvant Chemotherapy (XParTS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01412294
• Other study ID #: ECRIN-GC1106-XParTS
• Secondary ID: UMIN000005857
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 30, 2011
• Last updated: July 26, 2017
• Start date: July 2011
• Est. completion date: December 2017

Study information

• Verified date: July 2017
• Source: Epidemiological and Clinical Research Information Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate efficacy and safety of Capecitabine/Cisplatin for gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.

Description:

S-1/Cisplatin (SP) is one of the standard treatments of advanced gastric cancer. However, evidence of SP on gastric cancer recurrence after adjuvant therapy by the same drug (S-1) is not established. The aim of this study is to evaluate the efficacy and safety of Capecitabine/Cisplatin (XP) for gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Weeks to 74 Years

Eligibility

Inclusion Criteria:

1. Recurrent gastric cancer histologically confirmed as being adenocarcinoma

2. Age of 20 to 74 years with either gender

3. ECOG Performance Status of 0 to 2

4. Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1)

5. Post-gastrectomy adjuvant chemotherapy including S-1 for at least 12 weeks including interruption period

6. Less than 6 months treatment-free interval from completion of adjuvant therapy

7. In case with receiving neoadjuvant chemotherapy, the total dose of CDDP does not exceed 120mg/m2

8. Treatment-naïve recurrent gastric cancer

9. Life expectancy of at least 3 months after registration

10. Written informed consent

11. Adequate major organ functions within 14 days before registration

Exclusion Criteria:

12. Positive HER2 status

13. Previous treatment with platinum agents after curative surgery

14. Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents

15. Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency

16. More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment.

17. Obvious infection or inflammation (pyrexia = 38.0°C)

18. Active hepatitis

19. Heart disease that is serious or requires hospitalization, or history of such disease within past year

9) Concurrent illness that is serious or requires hospitalization (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver disorders, or hepatic cirrhosis)

10) Being treated or in need of treatment with phenytoin or warfarin potassium

11) Chronic diarrhea (watery stool or = 4 times/day)

12) Active gastrointestinal hemorrhage

13) Body cavity fluids requiring drainage or other treatment

14) Clinical suspicion or previous history of metastases to brain or meninges

15) Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant 16) Unwillingness to practice contraception

17) Poor oral intake

18) Psychiatric disorders which are being or may need to be treated with psychotropics

19) Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Capecitabine, Cisplatin
Drug: Capecitabine Capecitabine will be administered at 1,000 mg/m2 orally, twice daily (2,000 mg/m2 total daily dose) on Days 1 through 14 of each 21-day treatment cycle. Drug: Cisplatin Cisplatin will be administered at 80 mg/m2 by intravenous infusion on Day 1 of each 21-day treatment cycle.

Locations

Country	Name	City	State
Japan	Epidemiological and Clinical Research Information Network	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Epidemiological and Clinical Research Information Network

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		2 year
Secondary	Overall survival		2 year
Secondary	Response rate		2 year
Secondary	Time to treatment failure		2 year
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		2 year