Clinical trial · Interventional
Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ)
A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach and Gastroesophageal Junction
NCT00525785CI-TRIAL-00043285completedPhase 2Results postedClinicalTrials.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 goal of this clinical research study is to learn if a combination of 5-FU, Folinic Acid and Oxaliplatin, given with radiation therapy, is effective in the treatment of gastric or gastroesophageal cancers that will be removed by surgery if possible. The safety of this combination therapy will also be studied.
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 |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Folinic Acid | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5-Fluorouracil + Folinic Acid + Oxaliplatin
- description
- PreOp Chemotherapy: 2 cycles (each cycle consisting of 4 weeks or 2 treatments) of chemotherapy with oxaliplatin, folinic acid and infusional 5-FU (FOLFOX-48). Oxaliplatin 100 mg/m\^2 over 2 hours on day 1, folinic acid intravenous (IV) at 200 mg/m\^2 over 30 minutes on day 1, and 5-FU 2,200 mg/m\^2 over 48 hours as continuous infusion by outpatient pump starting on day 1. This therapy, FOLFOX-48 repeated every 2 weeks x 4 (8 weeks of induction chemotherapy). PreOp Chemoradiotherapy begins 12 days after last dose of PreOp Chemo 5FU plus oxaliplatin; A total of 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m\^2/d Monday through Friday) \& weekly oxaliplatin 45 mg/m\^2 over 2 hours for 5 weeks (oxaliplatin administered on the first day of radiation week). Surgical resection 4-6 weeks after completion of chemoradiotherapy
- interventionNames
- Drug: 5-Fluorouracil
- Drug: Folinic Acid
- Drug: Oxaliplatin
- Radiation: Radiotherapy
- Procedure: Surgery
Primary outcomes (1)
- measure
- Complete Pathologic Response Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with potentially resectable adenocarcinoma of the stomach with histologic proof of adenocarcinoma, clinically staged T2-3, any N, M0 or T1N1M0 Gastric carcinoma may involve the gastroesophageal junction, however, the bulk of the tumor must be in the stomach (defined by radiographs, endoscopy, or endoscopic ultrasonography). 2. No prior major surgery of the stomach or radiation therapy to the stomach or immunotherapy or chemotherapy. 3. Patients must have a performance status of \< 2 Zubrod scale. 4. Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of \>1,500/µL, and platelet count of \> 100,000/µL), adequate liver function (bilirubin \<= 1.5 mg/dl), and adequate renal function (creatinine \<= 1.5 mg/dl). 5. Pretreatment evaluations must be done per the guidelines in Section 8.0. 6. A feeding jejunostomy must be inserted in all patients. 7. Patient must sign an informed consent prior to study entry. 8. Patient must be chronologic \<= 75. Exclusion Criteria: 1. Patients with T1N0 MO or T4 carcinoma documented by endoscopic ultrasonography. 2. Positive cytology of pleural, or pericardial effusion or patients with any peritoneal disease diagnosed by laparoscopy. 3. Biopsy proof of lymph node metastases outside the study field such as supraclavicular, mediastinal, or para-aortic nodes. 4. Evidence of metastatic disease to distant organs (biopsy is suggested for questionable findings). 5. Patients with cardiac disease graded as New York Heart Association Class III or IV, severe uncontrolled diabetes, hypertension, cerebrovascular disease, or infection. 6. Patients with diabetic neuropathy. 7. Abnormalities of mental status such that either the patient cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements. 8. Presence of concurrent or previous malignancies in the past 5 years (except for resected squamous or basal cell carcinoma of the skin). 9. Pregnant women are excluded from study entry due to the potential teratogenic effects of the study treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.