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A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma


OBJECTIVES:

Primary

- Determine the pathologic complete response in patients with adenocarcinoma of the
esophagus or gastroesophageal junction treated with neoadjuvant therapy comprising
capecitabine, oxaliplatin, and radiotherapy.

Secondary

- Determine the clinical response rate in patients treated with this regimen.

- Determine the recurrence rate, time to progression, and patterns of failure in patients
treated with this regimen.

- Characterize the toxicity profile of this regimen in these patients.

OUTLINE:

- Induction therapy: Patients receive oral capecitabine twice daily on days 1-14 and
oxaliplatin IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for 2
courses in the absence of disease progression or unacceptable toxicity.

- Combination chemoradiotherapy: Patients then receive oxaliplatin IV over 2 hours once
weekly for 6 weeks. Patients also receive concurrent oral capecitabine twice daily and
undergo radiotherapy once daily 5 days a week for 5½ weeks in the absence of disease
progression or unacceptable toxicity.

- Surgery: Patients undergo surgical resection at 4-8 weeks after completion of
chemoradiotherapy.

After completion of study treatment, patients are followed every 3 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the esophagus or
gastroesophageal junction

- Stage I-IVA disease

- No distant metastatic disease (other than regional lymph nodes)

- No evidence of CNS metastases

- CNS metastases stable for > 3 months allowed

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Consuming ≥ 1,500 calories daily

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT ≤ 2.5 times ULN

- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No pre-existing neuropathy

- No prior unanticipated severe reaction to fluoropyrimidine therapy

- No known hypersensitivity to fluorouracil

- No known DPD deficiency

- No known hypersensitivity to any of the components of oxaliplatin

- No significant active infection or other severe complicated medical illness

- No clinically significant cardiac disease (e.g., congestive heart failure,
symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with
medication)

- No myocardial infarction within the past 12 months

- No history of uncontrolled seizures, CNS disorders, or psychiatric disability judged
by the investigator to be clinically significant, precluding informed consent, or
interfering with compliance of oral drug intake

- No malabsorption syndrome

- No other active malignancy within the past 3 years except cervical carcinoma in situ
or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

- More than 4 weeks since prior participation in any investigational drug study

- No prior pelvic or thoracic radiotherapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pathologic complete response

Outcome Time Frame:

At time of surgery

Safety Issue:

No

Principal Investigator

Mary Mulcahy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 05I2

NCT ID:

NCT00711412

Start Date:

October 2005

Completion Date:

February 2015

Related Keywords:

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

Name

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611