Phase 2 N=126 Randomized Treatment

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

Esophageal Cancer · Gastroesophageal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00525915 ↗

Enrolled (actual)

126

Serious AEs

13.5%

Results posted

Feb 2015

Primary outcome: Primary: Pathologic Complete Response Rate — 13; 26 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 5-Fluorouracil (Drug); Oxaliplatin (Drug); Radiation Therapy (Radiation); Surgery (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Pathologic Complete Response Rate	13; 26	—

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.

Eligibility Criteria

Inclusion Criteria

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) 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

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00525915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.