Clinical trial · Interventional
Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer
A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding
NCT01525771CI-TRIAL-00018397XPIDcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A maximum of 8 cycles of chemotherapy will be administered. Depending on patients' tolerability, 8 cycles of chemotherapy will be given to the patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Gastric Cancer With Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- No intervention
- description
- Single-center, open-label, prospective, single-arm, phase I-II study
- interventionNames
- Other: Docetaxel
Primary outcomes (1)
- measure
- Maximum tolerated dose
- timeFrame
- 1 year
- description
- Phase I Study \- Maximum tolerated dose of Intraperitoneal Docetaxel Phase II Study * Progression-free survival rate at 6 months * response rate, time to progression, overall survival
Secondary outcomes (4)
- measure
- Safety profile
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Unresectable or metastatic advanced gastric adenocarcinoma confirmed by histology 2. Peritoneal seeding proven by histology or cytology 3. Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy (But, patients who received docetaxel or cisplatin as adjuvant chemotherapy should be excluded) 4. Age 18 to 70 years old 5. Eastern Cooperative Oncology Group performance status \<\_ 2 6. Estimated life expectancy of more than 3 months 7. Adequate bone marrow function (WBCs\>3,000/µL and absolute neutrophil count (ANC) \>1,500/µL and platelets\>100,000/µL), 8. Adequate renal function: creatinine \< 1 x upper normal limit (UNL) or creatinine clearance \_\> 60ml/min 9. Adequate hepatic function: bilirubin \< 1.5 x UNL, AST/ALT levels \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL (except in case of bone metastasis without any liver disease) 10. Written informed consent Exclusion Criteria: 1. Contraindication to any drug contained in the chemotherapy regimen 2. Other tumor type than adenocarcinoma 3. Presence or history of CNS metastasis 4. Gastric outlet or bowel obstruction 5. Evidence of serious gastrointestinal bleeding 6. Peripheral neuropathy \> grade 2 7. History of significant neurologic or psychiatric disorders 8. History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix 9. Pregnant or lactating women, women of childbearing potential not employing adequate contraception 10. Other serious illness or medical conditions
References
Publications (0)
Data not yet available
No reference posted for this study.