Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00193128
• Date of registration: 12/09/2005
• Primary sponsor: Sarah Cannon Research Institute
• Public title: Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer
• Scientific title: A Phase I/II Trial of Preoperative Oxaliplatin, Docetaxel, and Capecitabine With Concurrent Radiation Therapy in Localized Carcinoma of the Esophagus or Gastroesophageal Junction
• Date of first enrolment: April 2004
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00193128
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: David R. Spigel, MD
• Affiliation: Sarah Cannon Research Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

- Adenocarcinoma or squamous cell carcinoma of the esophagus or G/E junction.

- Must be surgical candidates

- No previous treatment for esophageal cancer

- Must have measurable or evaluable disease

- Able to perform activities of daily living with minimal to no assistance

- Adequate bone marrow, liver and kidney function

- Provide written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

- Tumor location in the proximal esophagus

- Metastatic disease or locally advanced cancer

- Moderate to severe peripheral neuropathy

- Serious pre-existing medical illnesses

- Significant heart disease

- Treated for an invasive cancer within the previous 5 years

- Women who are pregnant or breast-feeding

- Age < 18 years

Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Esophagus Cancer

Intervention(s)

Drug: Capecitabine

Drug: Docetaxel

Drug: Oxaliplatin

Primary Outcome(s)

pathologic complete response rate [Time Frame: 18 months]

Secondary Outcome(s)

disease-free survival [Time Frame: 18 months]

Secondary ID(s)

IIT 14068

OX-03-127

SCRI GI 57

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Aventis Pharmaceuticals

Sanofi-Synthelabo