Clinical trial · Interventional
Response Rate and Side Effects of Preoperative Chemotherapy (TOX Regimen) in Patients With Locally Advanced Operable Gastric Adenocarcinoma
Phase 2 Study of Response Rate and Side Effects of Preoperative Chemotherapy With Docetaxel, Oxaliplatin and Capcitabine (TOX) in Patients With Locally Advanced Operable Gastric Adenocarcinoma
- 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)
Early stage diagnosis of gastric cancer has ensued different approaches in its resection strategies. In order to increase the proportion of cases that undergo radical resection and reduce the recurrence rate, different pre-operative treatments are introduced. Here, the investigators investigate an active preoperative chemotherapeutic regimen to in patients with locally advanced gastric 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pathological Response
- interventionNames
- Drug: TOX
Primary outcomes (1)
- measure
- Pathologic Response rate
- timeFrame
- Participants are assessed after 4 chemotherapy courses 3 weeks apart, an expected period of 12 weeks from starting the study treatment protocol.
- description
- A single expert pathologist evaluates the pathologic outcome of the chemotherapy regimen after the completion of courses. Participants are divided into 3 groups including complete pathologic response, partial pathologic response and pathologic stable disease.
Secondary outcomes (1)
- measure
- clinical Response rate
- timeFrame
- Participants are assessed after 2 courses of Chemotherapy 3 weeks apart, an expected period of 6 weeks from starting the study treatment protocol.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Tissue diagnosis of gastric or gastroesophageaql junction Adenocarcinoma * T3, T4 any N with non metastatic condition * Age 18 - 70 years * Performance status 0,1 according to ECOG criteria * Adequate bone marrow , liver and renal function * Hemoglobin ≥ 11 g/dl * Platelets ≥ 100000 / mm3 * Absolute Neutrophil Count ≥ 1500/mm3 * Normal Bilirubin * Normal Transaminases * Normal creatinin * Absence of active co-morbid illness (uncontrolled infection, uncontrolled DM, cardiopulmonary disease) Exclusion Criteria: * Any metastatic disease, T1, T2, N0
References
Publications (0)
Data not yet available