Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ)

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Sanofi-Synthelabo
• Treatments: Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

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.