Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer
A Phase I/II Trial of Preoperative Oxaliplatin, Docetaxel, and Capecitabine With Concurrent Radiation Therapy in Localized Carcinoma of the Esophagus or Gastroesophageal Junction
1 other identifier
interventional
59
1 country
7
Brief Summary
In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the 3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the 3-drug combination is considered too toxic, the phase II study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2004
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
May 13, 2013
CompletedNovember 24, 2021
October 1, 2021
3.8 years
September 12, 2005
March 26, 2013
October 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery
The absence of any residual tumor cells in a histologic evaluation of a tumor specimen following surgery is defined as a complete pathologic response
18 months
Secondary Outcomes (2)
Disease-Free Survival (DFS)
18 months
Overall Survival (OS)
36 months
Study Arms (2)
Cohort 1
EXPERIMENTALOxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions). Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved.
Cohort 2
EXPERIMENTALOxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions). Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved.
Interventions
40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts
20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts
In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35.
In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Sanofi-Synthelabocollaborator
- Aventis Pharmaceuticalscollaborator
Study Sites (7)
Tower Oncology
Beverly Hills, California, 90211, United States
Integrated Community Oncology Network
Jacksonville, Florida, 32256, United States
Atlanta Cancer Care
Atlanta, Georgia, 30342, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Wellstar Cancer Research
Marietta, Georgia, 30060, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
Related Publications (1)
Spigel DR, Greco FA, Meluch AA, Lane CM, Farley C, Gray JR, Clark BL, Burris HA 3rd, Hainsworth JD. Phase I/II trial of preoperative oxaliplatin, docetaxel, and capecitabine with concurrent radiation therapy in localized carcinoma of the esophagus or gastroesophageal junction. J Clin Oncol. 2010 May 1;28(13):2213-9. doi: 10.1200/JCO.2009.24.8773. Epub 2010 Mar 29.
PMID: 20351330RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
David R. Spigel, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
April 1, 2004
Primary Completion
February 1, 2008
Study Completion
January 1, 2009
Last Updated
November 24, 2021
Results First Posted
May 13, 2013
Record last verified: 2021-10