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Phase II Study of Preoperative Chemotherapy and Postoperative Chemo-Radiation for Newly Diagnosed, Potentially Resectable Gastric Cancer

Phase 2
18 Years
75 Years
Open (Enrolling)
Stomach Neoplasms

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Trial Information

Phase II Study of Preoperative Chemotherapy and Postoperative Chemo-Radiation for Newly Diagnosed, Potentially Resectable Gastric Cancer

Inclusion Criteria:

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.

Exclusion Criteria:

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of the study regimen.

Principal Investigator

Margarita Tokar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Soroka University Medical Center and Ben-Gurion University of the Negev


Israel: Ministry of Health

Study ID:




Start Date:

April 2007

Completion Date:

Related Keywords:

  • Stomach Neoplasms
  • Neoadjuvant chemotherapy
  • Adjuvant chemoradiotherapy
  • Adenocarcinoma of stomach and gastroesophageal junction
  • Neoplasms
  • Stomach Neoplasms