Phase II Study of Preoperative Chemotherapy and Postoperative Chemo-Radiation for Newly Diagnosed, Potentially Resectable Gastric Cancer
1. Histologically confirmed primary adenocarcinoma, poorly differentiated carcinoma, or
carcinoma not otherwise specified, of stomach or gastro-esophageal junction.
2. T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3
3. Disease must be clinically limited to the stomach or GEJ.
4. Pre-treatment Port-a-Cath insertion obligatory
5. No prior chemotherapy.
6. No prior radiotherapy.
7. Patients must be surgical candidates as determined by the treating surgeon.
8. Adequate organ function defined as:
9. Patients must have an ECOG Performance Status < 1.
10. Patients must be able to sign the informed consent document.
1. Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy,
endoscopic ultrasound and CT scanning.
2. Patients with primary carcinomas of the esophagus.
3. Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the
past 5 years, or prior esophageal or gastric surgery.
4. Patients with evidence of metastatic disease are not eligible.
5. New York Heart Association Class III or IV heart disease.
6. Severe co-morbid conditions or nonmalignant illness whose control may be jeopardized
by complications of the study treatment.
7. Pregnant or lactating women or men unable or unwilling to practice contraception are
8. Any history of prior malignancy (other than non-melanoma skin cancer, in-situ
cervical cancer, or superficial transitional cell bladder cancer).
9. Clinically significant hearing loss.
10. Patients with a history of seizure disorder who are receiving phenytoin,
phenobarbital, or other antiepileptic medication.
11. Patients who cannot fully comprehend the therapeutic implications of the protocol or
comply with its requirements.
12. Patients with any medical or psychiatric condition or disease which, in the
investigator’s judgment, would make the patient inappropriate for entry into this