Clinical trial · Interventional
Phase III Randomized Trial of Adjuvant XP Chemotherapy and XP/RT for Resected Gastric Adenocarcinoma
Phase III Randomized Controlled Trial of Adjuvant Capecitabine/Cisplatin Chemotherapy and Chemoradiation Therapy for Gastric Adenocarcinoma
NCT00323830CI-TRIAL-00005750completedPhase 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 objective of the trial is to compare disease-free survival between adjuvant capecitabine/cisplatin alone vs capecitabine/cisplatin with radiotherapy (chemoradiation) in curatively resected gastric cancer patients.
Conditions
Conditions (2)
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 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine, cisplatin, Radiotherapy (+/-) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- capecitabine/cisplatin/radiotherapy
- description
- postoperative XP/RT
- interventionNames
- Drug: Capecitabine, cisplatin, Radiotherapy (+/-)
- type
- ACTIVE_COMPARATOR
- label
- capecitabine/cisplatin
- description
- postoperative XP
- interventionNames
- Drug: Capecitabine, cisplatin, Radiotherapy (+/-)
Primary outcomes (1)
- measure
- disease free survival
- timeFrame
- 3-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven gastric adenocarcinoma 2. ≥ D2 resection 3. Stage IB(T1N1,T2bN0), II, IIIA, IIIB, IV(T4,N3 포함, M1 lymph node 제외) 4. 18 ≤ age ≤ 75 5. ECOG 0-2 6. No distant metastasis 7. Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl) 8. Adequate renal functions(serum creatinine ≤ 1.5mg/dl) 9. liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value) 10. Written informed consent Exclusion Criteria: 1. Previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer 2. Active infection requiring antibiotics 3. Pregnant, lactating women 4. Psychiatric illness, epileptic disorders 5. Concurrent systemic illness not appropriate for chemotherapy 6. Resection margin (+) 7. Pathologic stage IA 8. History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma 9. M1 lymph node (+) 10. D0, D1 resection
References
Publications (1)
- DERIVEDPark SH, Sohn TS, Lee J, Lim DH, Hong ME, Kim KM, Sohn I, Jung SH, Choi MG, Lee JH, Bae JM, Kim S, Kim ST, Park JO, Park YS, Lim HY, Kang WK. Phase III Trial to Compare Adjuvant Chemotherapy With Capecitabine and Cisplatin Versus Concurrent Chemoradiotherapy in Gastric Cancer: Final Report of the Adjuvant Chemoradiotherapy in Stomach Tumors Trial, Including Survival and Subset Analyses. J Clin Oncol. 2015 Oct 1;33(28):3130-6. doi: 10.1200/JCO.2014.58.3930. Epub 2015 Jan 5. PMID 25559811