Clinical trial NCT01412294: XParTS: Capecitabine/Cisplatin(XP) for Recurrent Gastric Cancer
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: gastric cancer
recurrent gastric cancer
adenocarcinoma of the stomach
capecitabine
xp
Lead sponsor: Epidemiological and Clinical Research Information Network
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 year
Secondary outcomes:
measure: Overall survival
timeFrame: 2 year
measure: Response rate
timeFrame: 2 year
measure: Time to treatment failure
timeFrame: 2 year
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 2 year
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Epidemiological and Clinical Research Information Network
Study officials:
affiliation: Shonan Kamakura Hospital
name: Akira Tsuburaya
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.