Clinical trial · Interventional
Perioperative Chemotherapy in Gastric Cancer
Treatment Discontinuation Associated With Perioperative Toxicity of FLOT Versus XELOX Chemotherapy in Patient With Resectable Gastric Cancer; Phase 2
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): High rate of disease progression in XELOX arm
Summary
Brief summary (as posted)
Patients with resectable adenocarcinoma of stomach or esophagogastric junction without previous therapy will be treated with one of two chemotherapy regimens perioperatively. One group of the patients will receive 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the second group will receive Oxaliplatin and Capecitabin (XELOX). Primary endpoint of the study is the proportion of patients who complete all allocated treatment.
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 |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Perioperative XELOX chemotherapy
- description
- Oxaliplatin 130 mg/m2, d1 Capecitabine 1000 mg/m² two times per day (BID), d1-14, every 3 weeks (q3w) 4 cycles (12 weeks) pre-OP and 3 cycles (12 weeks) post-OP
- interventionNames
- Drug: Capecitabine
- Drug: Oxaliplatin
- type
- EXPERIMENTAL
- label
- Perioperative FLOT chemotherapy
- description
- Docetaxel 50mg/m2, d1 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (8 weeks) pre-OP and 4 cycles (8 weeks) post-OP
- interventionNames
- Drug: Docetaxel
- Drug: Oxaliplatin
- Drug: Leucovorin
- Drug: Fluorouracil
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * cT1b-T4b (cT4b - invasion in diaphragm, parenchyma of liver, spleen, pancreas, abdominal wall, small bowel, colon, distal part of splenic artery) * cN0-3 * M0 * Age: 18 - 80 * ECOG: 0 - 1 * Histological type: adenocarcinoma * Differentiation grade: G0 - G4 * No previous surgery * No previous chemotherapy * No concomitant severe comorbidity * Written informed consent Exclusion Criteria: * cT1a, cT4b (invasion in truncus, hepatic artery, proximal part of splenic artery) * Presense of distant metastases * ECOG: 2 - 5 * Age: \<18 and \>80 * Severe concomitant comorbidity
References
Publications (1)
- DERIVEDDobrzhanskyi O, Kopetskyi V, Ross EA, Chernoff J, Shudrak Y, Kolesnyk A, Pepenin M, Horodetskyi A, Melnitchouk N, Kondratskyi Y. Treatment discontinuation associated with perioperative toxicity of FLOT versus XELOX chemotherapy in patients with resectable gastric cancer: prospective randomized trial (PECORINO). J Gastrointest Oncol. 2025 Jun 30;16(3):909-921. doi: 10.21037/jgo-2024-921. Epub 2025 Jun 24. PMID 40672074