At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- ✓Localized cancer potentially curable by surgery: T2N1-2M0 or T3-4 any N M0
- ✓No metastatic disease including ovarian metastases
- ✓Age 18 and over
- ✕Prior chemotherapy
- ✕Prior radiation therapy, except for skin cancer
- ✕Clinically significant auditory impairment
- ✕Significant heart disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Neoadjuvant Paclitaxel - Cisplatin Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer
In Brief
A Phase 2 clinical trial evaluating cisplatin, fluorouracil, and 4 other interventions for Gastric Cancer. Completed, enrolled 39 participants across 30 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells. E7296 was conducted to study neoadjuvant chemotherapy and postoperative chemoradiation therapy in patients diagnosed with high-risk gastric cancer using a new neoadjuvant regimen: paclitaxel plus cisplatin. It was hypothesized that this new neoadjuvant chemotherapy followed by surgery and chemoradiation therapy would be well tolerated and would have a high curative resection rate.
Study Details
Timeline
Interventions
Cisplatin was administered as part of the neoadjuvant regimen. It was given at a dose of 75 mg/m² via IV over approximately one hour, on day 1 of each cycle. Three cycles were given.
Postoperative regimen 5-FU, along with Leucovorin, was given by IV bolus, with 5-FU given immediately after the Leucovorin
Both 5-FU and Leucovorin will be given via IV bolus, with Leucovorin given immediately before 5-FU.
Paclitaxel was administered as part of the neoadjuvant regimen. It was given at a dose of 175 mg/m² as a 3 hour continuous intravenous infusion on day 1. Three cycles were given.
The surgical procedure performed involved a radical subtotal or total gastrectomy. A complete surgical resection was required
Concomitant chemotherapy and radiation therapy course: 5-FU 400 mg/m²/day + Leucovorin 20 mg/m²/day on days 1-4 of week one and days 1-3 of week 5 of XRT. Combined chemotherapy and radiation therapy were to begin 4 weeks after day 1 of the initial course of chemotherapy