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Oxaliplatin (NSC-266046) Plus Protracted Infusion 5-Fluorouracil And Radiation For Potentially Curable Esophageal Cancer: A Phase II Trial With Molecular Correlates

Phase 2
18 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

Oxaliplatin (NSC-266046) Plus Protracted Infusion 5-Fluorouracil And Radiation For Potentially Curable Esophageal Cancer: A Phase II Trial With Molecular Correlates



- Determine the pathologic complete response probability in patients with stage II or III
adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant
oxaliplatin, fluorouracil, and radiotherapy followed by definitive surgical resection.


- Determine the frequency and severity of toxic effects associated with this neoadjuvant
regimen in these patients.

- Determine the overall survival and progression-free survival of patients treated with
this regimen.

Exploratory Analyses (subject to funding availability)

- Correlate, preliminarily, initial messenger ribonucleic acid (mRNA) levels of the genes
for thymidylate synthase (TS), γ-glutamyl transpeptidase (γGT), γ-glutamyl cysteine
(γ-GCS), DNA excision repair cross-complementing (ERCC-1), and xeroderma pigmentosum
(XPA) with response and survival of patients treated with this regimen.

- Correlate, preliminarily, the mRNA levels of TS, γGT, γ-GCS, ERCC-1, and XPA before and
after treatment with this regimen with survival of these patients.

- Correlate, preliminarily, specific genetic polymorphisms of TS and ERCC-1 with tumor
response and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

- Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin IV over 2 hours on days 1,
15, and 29 and fluorouracil (5-FU) IV continuously on days 8-43. Beginning on day 8,
patients also undergo radiotherapy once daily, 5 days a week, for 5 weeks.

- Surgery: Patients with stable disease or better undergo surgical resection 4-10 weeks
after completion of chemoradiotherapy.

- Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive
chemotherapy comprising oxaliplatin IV over 2 hours on days 1, 15, and 29 and 5-FU IV
continuously on days 1-36.

Treatment continues in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 45-85 patients will be accrued for this study within 17-21

Inclusion Criteria


- Histologically confirmed primary adenocarcinoma of the thoracic esophagus or
gastroesophageal junction

- No recurrent disease

- Primary esophageal tumor at least 20 cm below the incisors (if < 26 cm below the
incisors, a bronchoscopy must be performed and cytology must be negative)

- Esophageal disease confined to esophagus and peri-esophageal soft tissue

- Gastroesophageal junction disease extending ≤ 2 cm into the gastric cardia

- Clinical stage II or III disease by CT scan or MRI

- If no esophageal mass is detected by these methods, esophageal endoscopic
ultrasound is required to determine stage

- Positron-emission tomography scan is required to confirm stage

- Measurable or non-measurable disease by x-ray, scanning, or physical examination

- No celiac axis nodes ≥ 1.5 cm

- Measurable regional lymph nodes ≥ 1.5 cm at stations 2-10=N1 OR subdiaphragmatic
lymph nodes at stations 15-19 ≤ 1.5 cm by CT scan or MRI allowed

- Palpable supraclavicular lymph nodes must be free of metastatic esophageal
cancer by biopsy



- Over 18

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- White blood cell (WBC) count ≥ 3,000/mm^3

- Hemoglobin ≥ 10.0 g/dL (transfusion allowed)


- Albumin ≥ 3 g/dL

- Bilirubin normal


- Creatinine ≤ 1.5 times upper limit of normal


- No myocardial infarction or cerebrovascular event within the past 6 months


- No active pneumonia or inflammatory lung infiltrate


- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- No peripheral neuropathy ≥ grade 2

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy

- Not specified


- No prior chemotherapy for esophageal cancer

Endocrine therapy

- Not specified


- No prior radiotherapy for esophageal cancer

- No concurrent intensity-modulated radiotherapy


- No prior surgical resection or attempted surgical resection of esophageal cancer

Type of Study:


Study Design:

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

Outcome Measure:

Pathological Complete Response

Outcome Description:

Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.

Outcome Time Frame:

10-16 weeks after beginning study treatment

Safety Issue:


Principal Investigator

Lawrence P. Leichman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Desert Regional Medical Center Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 2004

Completion Date:

August 2011

Related Keywords:

  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • stage II esophageal cancer
  • stage III esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



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