Clinical trial · Interventional
Trial of Adjuvant Chemotherapy for High Risk Gastric Cancer Patients
A Phase II Randomized Controlled Trial of Adjuvant Chemotherapy for High Risk Gastric Cancer Patients (IIIb-IIIc)
NCT01618474CI-TRIAL-00020273unknownPhase 2ClinicalTrials.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 trial is going to evaluate the efficacy and safety of two regimens of DX (docetaxel plus capecitabine)and XELOX (oxaliplatin plus capecitabine)as adjuvant chemotherapy for stage IIIb-IIIc gastric cancer patients after curative D2/D2+ operation, and to investigate the optimal adjuvant regimen for such extremely high risk patients.
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 |
|---|---|---|---|
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DX | Drug | — | UNRESOLVED |
| XELOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DX
- description
- DX: Docetaxel 60mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day1-14; 3 weeks a cycle for 8 consecutive cycles.
- interventionNames
- Drug: DX
- type
- ACTIVE_COMPARATOR
- label
- XELOX
- description
- XELOX: oxaliplatin 130mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day 1-14, 3 weeks a cycle for 8 consecutive cycles
- interventionNames
- Drug: XELOX
Primary outcomes (1)
- measure
- disease free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * a post operation histologically confirmed gastric or esophagogastric junction adenocarcinoma; * curative D2 or D2+ operation had been performed, and the pathological stage post operation was verified as IIIb or IIIc; * no adjuvant chemotherapy before or after operation; * Karnofsky performance status scale ≥ 70; * prior adjuvant chemotherapy that did not include taxanes and S-1; * white blood count ≥ 3,500/mm3, absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin count ≥ 90 g/dL, serum bilirubin level \< 1.5 of the upper limit of normal (ULN) for the institution, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase ≤ 2.5 ULN, serum albumin ≥ 30g/L, serum creatinine ≤ 1.5 ULN; and * normal cardiac function with no severe heart disease. Exclusion Criteria: Major exclusion criteria were as follows: * pregnancy or breast feeding; * past history of allergy to taxanes, platinum and 5-fluorouracil or their analogues; * radiotherapy for all measurable target lesions; * obstructive bowel disease; * past history of other cancers except for cured non-melanoma skin cancer or cervical cancer; and * concomitant treatment with other anticancer drugs.
References
Publications (0)
Data not yet available
No reference posted for this study.