Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

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

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: 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

Relevance to patient case: not relevant