Status:
COMPLETED
FDG-PET-CT and Biomarkers in Esophageal Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Gastrointestinal Disease
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical research study is to learn if the results of a positron emission tomography/computed tomography (PET/CT) scan done 10-14 days after beginning chemotherapy and radiation (chem...
Detailed Description
You have cancer of the esophagus and you and your doctor have agreed that you will have treatment with chemoradiation to try to shrink the cancer. You will then have surgery to remove any remaining tu...
Eligibility Criteria
Inclusion
- Patient must have histologic documentation of adenocarcinoma or squamous carcinoma of the esophagus at M. D. Anderson Cancer Center (MDACC).
- Patients with localized carcinoma of the esophagus who have undergone standard testing and been evaluated by the multidisciplinary team at MDACC and are considered appropriate candidates for and are willing to undergo chemoradiation therapy followed by surgery at MDACC. Radiation may be delivered as proton or photon. These patients have clinical stage II or III cancers and they are considered medically fit to undergo surgery.
- Patient must have undergone a baseline esophagealgastroduodenoscopy (EGD) with biopsy and endoscopic ultrasonography at MDACC, with tissue available for biomarker analysis.
- Patient must have undergone a baseline FDG-PET/CT at MDACC or an outside institution.
- Patient must be willing to undergo a research "early" FDG-PET/CT (12 +/- 2 days from the start of chemoradiation).
- Patient must provide written informed consent.
- Patient must be \>/= 18 years of age.
Exclusion
- Patient is unable or unwilling to comply with the requirements of the protocol.
- Patient had baseline FDG-PET/CT scan maximum SUV of \< 4.0.
- Patient is not a candidate for chemoradiation followed by surgery.
- Patients who received induction chemotherapy prior to chemoradiation therapy are excluded.
- Patients with T1N0 or T4anyN are excluded.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00833625
Start Date
February 1 2009
End Date
December 1 2015
Last Update
October 28 2016
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030