Clinical trial · Interventional
S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer
Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer
- 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)
RATIONALE: Drugs used in chemotherapy, such as S-1 and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may shrink the tumor so that it can be completely removed. PURPOSE: This phase II trial is studying how well giving S-1 together with irinotecan works in treating patients who are undergoing surgery for locally advanced stomach cancer.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| tegafur-gimeracil-oteracil potassium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Tumor shrinkage
- measure
- Historical tumor shrinkage
- measure
- Overall survival
- measure
- Progression-free survival
- measure
- Median survival
- measure
- Safety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed gastric adenocarcinoma
* Locally advanced disease
* Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)
* Planning to undergo curative surgery after neoadjuvant chemotherapy
PATIENT CHARACTERISTICS:
Age
* 20 to 75
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC 4,000-12,000/mm\^3
* Granulocyte count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
Hepatic
* AST and ALT ≤ 100 U/L
* Bilirubin ≤ 1.5 mg/dL
Renal
* Creatinine normal OR
* Creatinine clearance ≥ 50 mL/min
Pulmonary
* PaO\_2 \> 60 mm Hg on room air
Other
* Able to swallow oral medication
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior biologic therapy for gastric cancer
Chemotherapy
* No prior chemotherapy for gastric cancer
Endocrine therapy
* No prior endocrine therapy for gastric cancer
Radiotherapy
* No prior radiotherapy for gastric cancer
Surgery
* No prior surgery for gastric cancer
Other
* No other prior therapy for gastric cancerReferences
Publications (0)
Data not yet available