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

NCT ID: NCT01412294

Last Updated: 2017-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2017-12-31

Brief 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.

Detailed 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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Capecitabine, Cisplatin

Group Type: EXPERIMENTAL

Capecitabine, Cisplatin

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

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Weeks
• 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

Nishikawa K, Tsuburaya A, Yoshikawa T, Takahashi M, Tanabe K, Yamaguchi K, Yoshino S, Namikawa T, Aoyama T, Rino Y, Kawada J, Tsuji A, Taira K, Kimura Y, Kodera Y, Hirashima Y, Yabusaki H, Hirabayashi N, Fujitani K, Miyashita Y, Morita S, Sakamoto J. A phase II trial of capecitabine plus cisplatin (XP) for patients with advanced gastric cancer with early relapse after S-1 adjuvant therapy: XParTS-I trial. Gastric Cancer. 2018 Sep;21(5):811-818. doi: 10.1007/s10120-018-0815-0. Epub 2018 Feb 27.

Reference Type: DERIVED

PMID: 29488122 (View on PubMed)

Other Identifiers

UMIN000005857

Identifier Type: OTHER

Identifier Source: secondary_id

ECRIN-GC1106-XParTS

Identifier Type: -

Identifier Source: org_study_id