Gastric Cancer
Conditions
Keywords
gastric cancer, recurrent gastric cancer, adenocarcinoma of the stomach, capecitabine, xp
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.
Interventions
DRUGCapecitabine, 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.
Sponsors
Epidemiological and Clinical Research Information Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Weeks to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | 2 year |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 2 year |
| Response rate | 2 year |
| Time to treatment failure | 2 year |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 2 year |
Countries
Japan
Outcome results
None listed