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Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00711412
Recruitment Status : Active, not recruiting
First Posted : July 8, 2008
Last Update Posted : December 13, 2017
Information provided by (Responsible Party):
Northwestern University

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with esophageal or gastroesophageal junction cancer.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: Capecitabine - Induction Therapy Drug: Oxaliplatin - Induction Therapy Drug: Capcitabine - Combination Therapy Drug: Oxaliplatin - Combination Therapy Radiation: Radiation - Combination Therapy Phase 2

Detailed Description:



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


  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma
Study Start Date : October 2005
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Capecitabine, Oxaliplatin

Weeks 1-6:

Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8

Drug: Capecitabine - Induction Therapy
Two 21-day cycles will be given as induction. Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Drug: Oxaliplatin - Induction Therapy
Two 21-day cycles will be given as induction. Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over two hours on days 1 and 8 of each cycle.
Experimental: Capecitabine, Oxaliplatin, Radiation

Weeks 7-12:

Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday

Drug: Capcitabine - Combination Therapy
Two 21-day cycles will be given for combination therapy. Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Drug: Oxaliplatin - Combination Therapy
Two 21-day cycles will be given. Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Radiation: Radiation - Combination Therapy
1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.

Primary Outcome Measures :
  1. Pathologic complete response [ Time Frame: At time of surgery ]

Secondary Outcome Measures :
  1. Clinical response rate [ Time Frame: Following chemotherapy treatment and prior to surgery ]
  2. Recurrence rate [ Time Frame: At the time of disease recurrence or death ]
  3. Time to progression [ Time Frame: At the time of progression of disease ]
  4. Patterns of failure [ Time Frame: At time of surgery ]
  5. Toxicity profile [ Time Frame: During chemotherapy and up to 30 days post-last dose of chemotherapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • More than 4 weeks since prior participation in any investigational drug study
  • No prior pelvic or thoracic radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711412

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Principal Investigator: Mary Mulcahy, MD Robert H. Lurie Cancer Center

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00711412     History of Changes
Other Study ID Numbers: NU 05I2
STU00006779 ( Other Identifier: Northwestern University IRB )
First Posted: July 8, 2008    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Keywords provided by Northwestern University:
adenocarcinoma of the esophagus
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents