FDG-PET-CT and Biomarkers in Esophageal Cancer

Completed · Not applicable

Conditions studied: Gastrointestinal Disease, Esophageal Cancer

In brief

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 (chemoradiation) can predict how a patient with cancer of the esophagus will respond to chemoradiation. Researchers also want to learn if biomarkers (substances in the body associated with cancer) found in tumor tissue can predict response to chemoradiation.

Key facts

Study ID

NCT00833625

Run by

M.D. Anderson Cancer Center

People needed

31

Starts

2009-02-01

Expected to finish

2015-12-01

Last updated by the study team

2016-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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