Clinical trial · Interventional
Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
A Phase II Trial of Neoadjuvant Paclitaxel - Cisplatin Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer
- 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)
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.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
- interventionNames
- Drug: cisplatin
- Drug: fluorouracil
- Drug: leucovorin calcium
- Drug: paclitaxel
- Procedure: surgery
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Grade 3 or Higher Toxicity Incidence on Step 1
- timeFrame
- assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction * Localized cancer that is potentially curable by surgery (T2, N1-2, M0 or T3-4, any N, M0) * No metastatic cancer to the ovaries * Age: 18 and over * Easter Cooperative Oncology Group (ECOG) performance status 0-2 * White blood cell (WBC) count at least 4,000 cells/mm3 * Platelet count at least 150,000/mm3 * Bilirubin less than 2 mg/dL * Creatinine no greater than 1.5 mg/dL * Creatinine clearance greater than 50 mL/min * Caloric intake must be at least 1500 kcal/day * No prior history of cancer within the past 5 years except for basal cell carcinoma of the skin or in situ carcinoma of the cervix * No prior radiation therapy, except for skin cancer * Fertile patients must use adequate contraception * Met criteria for re-registration after surgery * T1N1-2M0, T2N1-2M0 or T3-4NanyM0 at time of initial re-registration. * No evidence of metastatic disease from postoperative pathologic staging. * ECOG performance status of 0, 1, or 2 at re-registration * Curative resection performed * Re-registered 4 - 6 weeks from the date of surgery * WBC ≥ 4000 cells/mm³, platelets ≥ 150,000/mm³, creatinine ≤ 1.5 mg/dl or creatinine clearance of \> 50 ml/min (measured or calculated) and total serum bilirubin \< 2 mg/dl, all within four weeks prior to re-registration Exclusion Criteria: * Prior chemotherapy * Clinically significant auditory impairment * Significant heart disease * Pregnant or lactating
References
Publications (1)
- RESULTChakravarthy AB, Catalano PJ, Mondschein JK, Rosenthal DI, Haller DG, Whittington R, Spitz FR, Wagner H, Sigurdson ER, Tschetter LK, Bayer GK, Mulcahy MF, Benson AB. Phase II Trial of Paclitaxel/Cisplatin Followed by Surgery and Adjuvant Radiation Therapy and 5-Fluorouracil/Leucovorin for Gastric Cancer (ECOG E7296). Gastrointest Cancer Res. 2012 Nov;5(6):191-7. PMID 23293700