XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

A Randomized Phase II Trial Comparing Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer (XParTS II)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01406249
• Other study ID #: ECRIN-GC1107-XParTS II
• Secondary ID: UMIN000006045
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 28, 2011
• Last updated: July 26, 2017
• Start date: August 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 elucidate the efficacy and safety of XP and SP for first-line treatment of Advanced Gastric Cancer.

Description:

XP and SP are either standard treatment for advanced gastric cancer. The aim of this study is to elucidate the efficacy and safety of Capecitabine/Cisplatin and S-1/Cisplatin for first-line treatment of Advanced Gastric Cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

Inclusion Criteria:

1. Histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease

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

3. No previous chemotherapy or radiotherapy. However, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy

4. ECOG Performance Status of 0 to 2

5. Life expectancy of at least 3 months after registration

6. Written informed consent

7. Age of 20 to 74 years with either gender

8. Adequate Major organ functions within 14 days before registration

Exclusion Criteria:

1. Positive HER2 status

2. Previous history of fluoropyrimidines therapy within 6 months prior to registration

3. Previous treatment with platinum agents

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

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

6. 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.

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

8. Active hepatitis

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

10. Having complication 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)

11. Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium

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

13. Active gastrointestinal bleeding

14. Body cavity fluids requiring drainage or other treatment

15. Clinical suspicion or previous history of metastasis to brain or meninges

16. Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant

17. Unwillingness to practice contraception

18. Poor oral intake

19. Psychiatric disorders which are being or may need to be treated with psychotropics

20. 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:
• SP
Drug: S-1: S-1 will be administered at 40 mg/m2 orally, twice daily (80 mg/m2 total daily dose) on Days 1 through 21 of each 35-day treatment cycle. Drug: Cisplatin: Cisplatin will be administered at 60 mg/m2 by intravenous infusion on Day 8 of each 35-day treatment cycle.
• XP
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 rate		at 24weeks from patient enrollment
Secondary	Time-to treatment failure		3year
Secondary	Response rate		3 year
Secondary	Overall survival		3 year
Secondary	Safety		3 year