Clinical trial · Interventional
Adjuvant Chemoradiation Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma
A Pilot Study of Adjuvant Chemoradiation After Resection of Gastric Or Gastroesophageal Junction Adenocarcinoma
NCT00215514CI-TRIAL-00015238completedEarly Phase 1ClinicalTrials.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 main purpose of this trial is to determine how well patients with gastric or gastroesophageal junction adenocarcinoma respond to chemotherapy with epirubicin, cisplatin and 5-fluorouracil followed by continuous infusion 5-fluorouracil chemotherapy given along with radiation therapy.
Conditions
Conditions (3)
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 |
| Gastro-esophageal Junction Cancer | Gastric Neoplasm | PROBABILISTIC | 0.70 |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil (5-FU) | Drug | Fluorouracil | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Radiation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ECF followed by 5-FU/RT followed by ECF
- interventionNames
- Drug: Epirubicin
- Drug: Cisplatin
- Drug: 5-Fluorouracil (5-FU)
- Procedure: Radiation
Primary outcomes (1)
- measure
- To assess patient tolerance and toxicity of postoperative adjuvant regimen using epirubicin, cisplatin, and infusional 5-FU before and after a course of radiotherapy among patients with curatively resected gastric or gastroesophageal adenocarcinoma.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinomas of the esophagus that are not involving the gastroesophageal junction are not eligible. * Patients must have had en bloc resection of all known tumor and be at high risk for later failure. The surgical resection must have been done with a curative intent. The stomach, lver, peritoneum, omentum and regional lymph nodes must be evaluated and all identified tumor be resected. * The surgical specimen, and the pathologic analysis thereof, must be adequate for TNM staging. * Treatment must begin between day 20 and day 56 after the gastrectomy. * ECOG performance status of 0,1 or 2 * ANC \> 1,500/ul and platelet count \>100,000/ul * Serum creatinine \< 1.5mg/dl * Total bilirubin \< 2.0 mg/dl and AST \< 3 x ULN * Estimated caloric intake of 1500K calories per day or greater Exclusion Criteria: * Known unresected cancer, microscopic evidence of tumor at the line of resection, noncontiguous resection of tumor, or M1 disease * Ascites, peritoneal seeding, liver metastasis or extra-abdominal metastasis * Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, non-invasive carcinoma in situ which has been fully resected, or other cancer for which the patient has been disease free for five years * Previous chemotherapy or radiotherapy * Active infectious process * Pregnant or lactating women * Myocardial infarction in the past 6 months or prior history of congestive heart failure or significant valvular heart disease * Uncontrolled serious medical or psychiatric condition * Grade 2 or greater peripheral neuropathy at baseline
References
Publications (0)
Data not yet available
No reference posted for this study.