Clinical trial · Interventional
A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
NCT00123318CI-TRIAL-00010759completedPhase 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 determine the side-effects and effectiveness of a new type of chemoradiotherapy treatment for patients who have had surgery for stomach cancer. The treatment uses epirubicin, cisplatin, and 5-fluorouracil (ECF) chemotherapy together with radiotherapy.
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 |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| epirubicin | Drug | Epirubicin | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)
- interventionNames
- Drug: epirubicin
- Drug: cisplatin
- Drug: 5-fluorouracil
- Radiation: Radiotherapy
Primary outcomes (3)
- measure
- The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity
- timeFrame
- Final analysis will be at 3 years.
- measure
- The percentage of patients who complete the planned chemoradiation protocol
- timeFrame
- Final analysis will be at 3 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: All of the following must apply: * Histologically proven adenocarcinoma of the stomach or gastro-oesophageal junction that is: 1. completely resected with negative margins 2. Stage T3,4 and/or N1,2 patients who have undergone a D2 nodal dissection can be entered on the study at the discretion of the treating clinician. * Age greater than or equal to 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2 * Adequate organ function defined as follows: * Bone marrow: Haemoglobin greater than or equal to 90 g/L; Neutrophil count greater than or equal to 1.5 x 10\^9 /L; Platelet count greater than or equal to 100 x 10\^9 /L * Hepatic: Serum bilirubin less than or equal to 1.5 x ULN; AST and/or ALT less than or equal to 3.0 x ULN; * Renal: Serum creatinine less than or equal to 0.150 mmol/L, and calculated creatinine clearance greater than or equal to 50mL/min. * Adequate oral nutrition (intake greater than or equal to 1500 calories/day). This is to be assessed by a dietician prior to commencing treatment. * Disease which can be radically treated to 45 Gy with standard fractionation. * Patient able to be treated with infusional 5-fluorouracil (5-FU) and ECF chemotherapy. * Written informed consent Exclusion Criteria: None of the following must apply: * Evidence of metastatic disease. * Prior chemotherapy or radiotherapy * Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled. * Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures. * Cardiac failure (relevant to the use of epirubicin): * Patients with myocardial infarction within the last 6 months; * Patients with New York Heart Association class III/IV congestive heart failure
References
Publications (0)
Data not yet available
No reference posted for this study.