Clinical trial · Interventional
A Randomized Phase III Study of Adjuvant Chemotherapy With or Without Chemo-radiotherapy in Patients With Local Advanced Gastric Cancer After D2 Resection.
NCT02648841CI-TRIAL-00020455unknownPhase 3ClinicalTrials.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)
The purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients with local 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant chemotherapy for active comparator group | Drug | — | UNRESOLVED |
| Adjuvant chemotherapy for experimental group | Drug | — | UNRESOLVED |
| Adjuvant Concurrent Chemo-radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Adjuvant Chemotherapy
- description
- The interventions of adjuvant chemotherapy group is 8 cycles of SOX(S-1+Oxaliplatin) chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
- interventionNames
- Drug: Adjuvant chemotherapy for active comparator group
- type
- EXPERIMENTAL
- label
- Adjuvant Chemo-radiotherapy
- description
- The interventions of adjuvant chemo-radiotherapy group is concurrent chemo-radiotherapy to be give after 4-6 cycles of chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral. Six cycles of SOX chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
- interventionNames
- Radiation: Adjuvant Concurrent Chemo-radiotherapy
- Drug: Adjuvant chemotherapy for experimental group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Gastric cancer; * D2 and R0 resection; * Pathologically confirmed stage anyT, N+, M0 (AJCC Cancer Staging); * Karnofsky performance score (KPS) \>= 70 or Eastern Cooperative Oncology Group(ECOG) score 0-1; * Adequate blood counts: White blood cell count ≥3.5 x 109/L Haemoglobin levels ≥100g/L Platelet count ≥100 x 109/L Creatinine levels ≤1.0× upper normal limit(UNL) Urea nitrogen levels ≤1.0× upper normal limit(UNL) Alanine aminotransferase(ALT) ≤1.5× upper normal limit(UNL) Aspartate aminotransferase(AST) ≤1.5× upper normal limit(UNL) Alkaline phosphatase(ALP) ≤1.5× upper normal limit(UNL) Total bilirubin(TBIL) ≤1.5× upper normal limit(UNL) * No allergic history of 5-Fu or Platinum drugs; * No history of chemotherapy or other anti-cancer therapy; * Informed consent should be signed. Exclusion Criteria: * GEJ adenocarcinoma * Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma) * Allergic to Fluorouracil or Platinum drugs; * Concurrent uncontrolled medical condition; * Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract; * Severe postoperative complications such as anastomotic leakage, etc.; * Symptoms or history of peripheral neuropathy.
References
Publications (0)
Data not yet available
No reference posted for this study.