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

Completed · Phase 2

Conditions studied: Esophageal Cancer, Gastroesophageal Cancer

In brief

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.

Key facts

Study ID: NCT00525915
Run by: M.D. Anderson Cancer Center
People needed: 126
Starts: 2005-04-01
Expected to finish: 2013-03-01
Last updated by the study team: 2015-02-09

Who can join

Age: 18 and older, up to 76. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Local regional carcinoma of the thoracic esophagus (squamous cell or adeno) or gastroesophageal junction.
Patients with T1N1, and T2-3 with any N (M1a only) will be eligible.
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).
Performance status 0 or 1.
Signed informed consent by the investigator or their designee and patient.
Medically fit for surgery.
No Celiac (except for the GE junction cancers), supraclavicular, or paraaortic nodal enlargement unless biopsy negative.
None of the celiac nodes should be larger than 2 cm
Male or Female but both sexes must practice adequate contraception while on therapy
>/=18 years but less than 76 years
No known allergy to any of the study drugs.
No prior therapy for this cancer.
No significant cancer (defined as non-melanomatous skin cancers and treated cervical cancers) within the past 5 years
New York Heart Association (NYHA) I and II

You may not qualify if…

Patients with T1N0, T4, or M1b cancer will be excluded
Significant comorbid conditions (defined as uncontrolled diabetes, active angina or heart failure, uncontrolled hypertension, or active psychiatric condition that prevents consistent participation and compliance).
More than grade 1 neuropathy
Unable to comprehend the requirements of the study or comply with it.

Where it is running

UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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