Phase 2
N=59
Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer
Esophagus Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00193128 ↗Enrolled (actual)
59
Serious AEs
59.3%
Results posted
May 2013
Primary outcome: Primary: Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery — 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxaliplatin (Drug); Docetaxel (Drug); Capecitabine (Drug); Radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SCRI Development Innovations, LLC
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery |
24 | — |
| SECONDARY Disease-Free Survival (DFS) |
16.3 | — |
| SECONDARY Overall Survival (OS) |
24.1 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00193128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.