Oxaliplatin-Based Chemotherapy and Chemoradiotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Carcinoma

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if a combination of the investigational drug oxaliplatin with 5-Fluorouracil (5-FU) (given at the same time as radiation therapy) is as effective as a combination of these two drugs given before and during radiation therapy in the treatment of esophageal or gastroesophageal cancers. The safety of these combinations of therapy will also be compared.

Objectives:

Primary objective:

Compare the Pathologic Complete Response rate and % of patients with <50% residual cancer in the resected surgical specimen between Arms A and B.

Secondary objectives:

1. Compare 1-year and 3-year survival rates, median survival time, R0 resection rates, safety, and local plus systemic relapse rates between Arms A and B

2. Perform exploratory correlative studies on blood, adjacent normal and cancer tissue to assess predictive markers of response and outcome.

3. Evaluate the joint effects, including possible interactive effects, of proton-versus-photon therapy and treatment arm on overall survival, R0 resection rates, safety, and local plus systemic relapse rates.

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

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Sanofi
• Treatments: Fluorouracil; Oxaliplatin

Criteria

Inclusion Criteria:

1. Local regional carcinoma of the thoracic esophagus (squamous cell or adeno) or gastroesophageal junction.

2. Patients with T1N1, and T2-3 with any N (M1a only) will be eligible.

3. Normal liver (serum glutamic-pyruvic transaminase (SGPT) < 56µL, Total Bilirubin <1.5 mg/dL), kidney (Creatinine <1.75 mg/dL), and bone marrow functions (AGN >1,500µL, platelet count >100,000/µL).

4. Performance status 0 or 1.

5. Signed informed consent by the investigator or their designee and patient.

6. Medically fit for surgery.

7. No Celiac (except for the GE junction cancers), supraclavicular, or paraaortic nodal enlargement unless biopsy negative.

8. None of the celiac nodes should be larger than 2 cm

9. Male or Female but both sexes must practice adequate contraception while on therapy

10. >/=18 years but less than 76 years

11. No known allergy to any of the study drugs.

12. No prior therapy for this cancer.

13. No significant cancer (defined as non-melanomatous skin cancers and treated cervical cancers) within the past 5 years

14. New York Heart Association (NYHA) I and II

Exclusion Criteria:

1. Patients with T1N0, T4, or M1b cancer will be excluded

2. Significant comorbid conditions (defined as uncontrolled diabetes, active angina or heart failure, uncontrolled hypertension, or active psychiatric condition that prevents consistent participation and compliance).

3. More than grade 1 neuropathy

4. Unable to comprehend the requirements of the study or comply with it.