Clinical trial · Observational
Observational Study of Perioperative Chemotherapy in Gastric Cancer
Prospective Observational Study of Patients With Locally Advanced Gastric Cancer Treated With Perioperative Chemotherapy and Surgery
NCT01633203CI-TRIAL-00044822PRECISOcompletedClinicalTrials.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)
This study will assess the efficacy and toxicity of perioperative chemotherapy with Epirubicin + Cisplatin + Capecitabine (ECX) in routine clinical practice in a network of public hospitals in Santiago, Chile.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epirubicin + cisplatin + capecitabine polychemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- locally advanced gastric cancer
- description
- Patients with resectable, locally advanced cT3-4 and/or N+ gastric carcinoma treated with 3 perioperative epirubicin cisplatin capecitabine polychemotherapy
- interventionNames
- Drug: epirubicin + cisplatin + capecitabine polychemotherapy
Primary outcomes (1)
- measure
- Rate of downstaging
- timeFrame
- through study completion, an average of 3 months
- description
- To determine the rate of downstaging of locally advanced cT3-4 and/or N+ gastric carcinomas after 3 cycles of preoperative chemotherapy with ECX
Secondary outcomes (10)
- measure
- Rate of adverse events
- timeFrame
- through study completion, an average of 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven invasive carcinoma * Age \> 18 years. * ECOG performance status 0 or 1. * Hemoglobin \> 9 g/dL * Absolute neutrophil count \> 1.5 x 109/L * Platelet count \> 100 x 109/L * Creatinine \< 1.5 ULN * Creatinine clearance \> 60 mL/min * Serum bilirubin \< 1.5 x ULN * AST \< 2.5 x ULN * Women of child bearing potential: must agree to use an effective contraceptive method. * Signed informed consent. Exclusion Criteria: * ECOG \> 2. * Pre-existing diarrhea uncontrolled with supportive care. * Inability to swallow Xeloda tablets. * History of mild-to-moderate renal insufficiency (creatinine clearance \< 45 mL/min). * Signs or symptoms of clinically significant hepatic dysfunction (bilirubin \> 1.5 ULN, FA \> 2.5 ULN, albumin \< 2,5 g/dL). * Significant cardiac dysfunction (LVEF \< LLN) * Presence of distant metastasis, including clinical signs of peritoneal carcinomatosis * Symptomatic gastric retention or severe dysphagia with a caloric intake of \< 1500 kcal/day * Histology of lymphoma, GIST or neuroendocrine tumor * Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use an effective method of contraception. * Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include congestive heart failure of Class III or IV of the NYHA classification, infection requiring parental or oral treatment, any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent.
References
Publications (3)
- BACKGROUNDCunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531. PMID 16822992
- BACKGROUNDOkines AFC, Norman AR, McCloud P, Kang YK, Cunningham D. Meta-analysis of the REAL-2 and ML17032 trials: evaluating capecitabine-based combination chemotherapy and infused 5-fluorouracil-based combination chemotherapy for the treatment of advanced oesophago-gastric cancer. Ann Oncol. 2009 Sep;20(9):1529-1534. doi: 10.1093/annonc/mdp047. Epub 2009 May 27. PMID 19474114
- BACKGROUNDGarcia CC, Benavides CC, Apablaza SP, Rubilar PO, Covacevich SR, Penaloza PM, Guerra JC, Horwitz BZ, Domancic PH, Bustamante R M, Romero S C. [Surgical treatment of gastric cancer: results in 423 cases]. Rev Med Chil. 2007 Jun;135(6):687-95. Epub 2007 Aug 22. Spanish. PMID 17728893