Clinical trial · Interventional
Neoadjuvant Chemoradiotherapy vs. Chemotherapy Followed by Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer
A Randomized, Open-Label, Multicenter, Controlled Phase III Trial Comparing Neoadjuvant Chemoradiotherapy Followed by Surgery and Adjuvant Chemotherapy Versus Neoadjuvant Chemotherapy Followed by Surgery and Adjuvant 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)
Patients with histologically confirmed gastric adenocarcinoma with locally advanced gastric cancer are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy or neoadjuvant chemotherapy alone using XELOX regimen following D2 gastrectomy and adjuvant chemotherapy for 3 cycles. The primary end point is 3-year disease free survival (DFS), and secondary end point is 5-year overall survival (OS), R0 resection rate, pathological complete remission (pCR) and treatment safety.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Chemotherapy | Drug | Adjuvant Chemotherapy | ALIAS |
| Neoadjuvant Chemoradiotherapy | Radiation | — | UNRESOLVED |
| Neoadjuvant Chemotherapy | Drug | — | UNRESOLVED |
| R0 D2 Gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Chemoradiotherapy
- description
- Radiotherapy (45Gy/25f) + 3 cycles of XELOX Chemotherapy \[Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle (non-concurrent); Oxaliplatin 100 mg/m² IV on Day 1 + Capecitabine 825 mg/m² orally BID on Days 1-14 of a 21-day cycle (concurrent chemoradiotherapy) \] following with D2 Gastrectomy and 3 cycles of Adjuvant XELOX Chemotherapy
- interventionNames
- Radiation: Neoadjuvant Chemoradiotherapy
- Procedure: R0 D2 Gastrectomy
- Drug: Adjuvant Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant Chemotherapy
- description
- 3 cycles of XELOX Chemotherapy (Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle) following with D2 Gastrectomy and 3 cycles of Adjuvant XELOX Chemotherapy
- interventionNames
- Drug: Neoadjuvant Chemotherapy
- Procedure: R0 D2 Gastrectomy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed gastric cancer with clinical staging determined by endoscopic ultrasound and contrast-enhanced CT or MRI as cT3N2/N3M0, cT4aN+M0, or cT4bNanyM0. 2. Good general condition, with Eastern Cooperative Oncology Group (ECOG) performance status \<2 and no contraindications to surgery. 3. Ambulatory male or female patients aged 18 to 75 years. 4. Sufficient physical fitness and organ function to tolerate major abdominal surgery. 5. Baseline laboratory parameters meeting the following criteria: WBC \> 4.0 × 10⁹/L, ANC \> 1.5 × 10⁹/L, Hb ≥ 100 g/L, PLT ≥ 100 × 10⁹/L, total bilirubin ≤ 1.5 × upper limit of normal (ULN), AST and ALT ≤ 2.5 × ULN, and serum creatinine ≤ 1.0 × ULN. 6. No prior or concurrent diagnosis of other malignancies. 7. Willing and able to comply with study protocol requirements during the trial period. 8. Provided written informed consent prior to screening, with full awareness of the right to withdraw from the study at any time without consequence. 9. Estimated life expectancy of at least 3 months. Exclusion Criteria: 1. Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception. 2. Receipt of any antitumor therapy prior to surgery. 3. History of or concurrent malignancies other than gastric cancer. 4. Presence of psychiatric disorders, brain metastases, or leptomeningeal metastases. 5. Uncontrolled or severe comorbid conditions or active infections. 6. Decompensated dysfunction of major organs (e.g., cardiac, pulmonary, hepatic, or renal failure). 7. Concurrent participation in another clinical trial. 8. Contraindications to chemotherapy, radiotherapy, or surgery. 9. Active hepatitis B or hepatitis C virus infection. 10. Grade ≥2 peripheral neuropathy (per NCI-CTCAE). 11. Chronic intestinal diseases or short bowel syndrome. 12. Known dihydropyrimidine dehydrogenase (DPD) deficiency. 13. Known hypersensitivity to capecitabine or any of its excipients. 14. Ongoing treatment with sorivudine or related analogs. 15. Deemed unsuitable for participation in this clinical trial by the investigator.
References
Publications (0)
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