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

NCT ID: NCT01406249

Last Updated: 2017-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2017-12-31

Brief 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.

Detailed 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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S-1,Cisplatin

Group Type: ACTIVE_COMPARATOR

SP

Intervention Type: DRUG

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.

Capecitabine, Cisplatin

Group Type: EXPERIMENTAL

XP

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Epidemiological and Clinical Research Information Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Akira Tsuburaya

Role: PRINCIPAL_INVESTIGATOR

Shonan Kamakura Hospital

Locations

Epidemiological and Clinical Research Information Network

Kyoto, , Japan

Countries

Japan

References

Tsuburaya A, Morita S, Kodera Y, Kobayashi M, Shitara K, Yamaguchi K, Yoshikawa T, Yoshida K, Yoshino S, Sakamoto J. A randomized phase II trial to elucidate the efficacy of capecitabine plus cisplatin (XP) and S-1 plus cisplatin (SP) as a first-line treatment for advanced gastric cancer: XP ascertainment vs. SP randomized PII trial (XParTS II). BMC Cancer. 2012 Jul 23;12:307. doi: 10.1186/1471-2407-12-307.

Reference Type: DERIVED

PMID: 22824079 (View on PubMed)

Other Identifiers

UMIN000006045

Identifier Type: OTHER

Identifier Source: secondary_id

ECRIN-GC1107-XParTS II

Identifier Type: -

Identifier Source: org_study_id