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FDG-PET-CT and Biomarkers to Assess Pathologic Response in Surgical Specimens of Patients With Localized Esophageal Cancer After Chemoradiation

18 Years
Open (Enrolling)
Gastrointestinal Disease, Esophageal Cancer

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Trial Information

FDG-PET-CT and Biomarkers to Assess Pathologic Response in Surgical Specimens of Patients With Localized Esophageal Cancer After Chemoradiation

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 tumor.

How well cancer of the esophagus responds to chemoradiation varies from person to person.
Currently, doctors cannot tell before surgery in which patients the chemoradiation will kill
all of the cancer, some of the cancer, or not much of the cancer. Studying patients' PET/CT
scans and tumor tissue for biomarkers may help researchers predict how an individual patient
will respond to chemoradiation. This could spare future patients from having unnecessary
surgery or chemoradiation treatment that is not effective.

PET and CT scans are both standard imaging tests that doctors use to find cancer in the
body. The PET scan detects the signal of actively growing cancer cells in the body and the
CT scan shows the location, size, and shape of the cancer. Combining these scans provides
more complete information on cancer location, growth, and changes in the cancer over time.

Currently, routine testing for esophageal cancer at MD Anderson includes a PET/CT scan at
the time of diagnosis and 5 or 6 weeks after chemoradiation is completed. Researchers hope
that analyzing changes seen in an "early" PET/CT scan (performed between 10-14 days after
starting chemoradiation) compared to the PET/CT scan taken at the time of diagnosis may
predict how well the chemoradiation will work against the patient's cancer.

PET/CT Scan:

If you are found to be eligible to take part in this study, 10-14 days after you start your
chemoradiation treatment you will have a PET/CT scan performed.

You will need to fast (not have anything to eat or drink except water) for 4-6 hours before
the PET/CT scan. Blood (about 1 teaspoon) will be drawn to check your blood sugar level.

You will receive a small amount of fluorodeoxyglucose (FDG) solution by vein. Cancer cells
use sugar at a higher rate than normal cells do. FDG is a radioactive form of glucose
(sugar) commonly used during a PET scan. The FDG helps show areas in the body where there
is cancer cell growth. After receiving the FDG solution, you will rest in a quiet, darkened
room for 45-60 minutes before the PET/CT scan. The entire procedure should take about 3

This PET/CT scan will be compared to your routine PET/CT scan. Your doctor will tell you of
the results of this PET/CT scan. However, the results will not change the planned treatment
you receive, unless the scan shows that the disease has gotten worse.

Biomarkers Testing:

Researchers will collected samples of tumor tissue previously collected at MD Anderson. This
tissue will be used for biomarker testing.

Length of Study:

You will be off active study once you complete the PET/CT scan.

Medical Record Information Collection and Long-Term Follow-Up:

The study staff will collect information from your medical record on tests, evaluations, and
treatments you receive as part of your routine care. The study staff will continue to
collect this information from your medical record as long as you are a patient at MD

If you stop coming to MD Anderson, you will be called by the study staff every 3 months
after surgery for the first year and then every 6 months after that. During this call, you
will be asked about your health status. The call should take about 5 minutes.

This is an investigational study. PET/CT scans are routine tests for patients with cancer
of the esophagus. The early PET/CT scan for the purpose of this study is investigational.

Up to 95 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patient must have histologic documentation of adenocarcinoma or squamous carcinoma of
the esophagus at M. D. Anderson Cancer Center (MDACC).

2. 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.

3. Patient must have undergone a baseline esophagealgastroduodenoscopy (EGD) with biopsy
and endoscopic ultrasonography at MDACC, with tissue available for biomarker

4. Patient must have undergone a baseline FDG-PET/CT at MDACC or an outside institution.

5. Patient must be willing to undergo a research "early" FDG-PET/CT (12 +/- 2 days from
the start of chemoradiation).

6. Patient must provide written informed consent.

7. Patient must be >/= 18 years of age.

Exclusion Criteria:

1. Patient is unable or unwilling to comply with the requirements of the protocol.

2. Patient had baseline FDG-PET/CT scan maximum SUV of < 4.0.

3. Patient is not a candidate for chemoradiation followed by surgery.

4. Patients who received induction chemotherapy prior to chemoradiation therapy are

5. Patients with T1N0 or T4anyN are excluded.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Pathologic Response

Outcome Description:

From baseline PET-CT to "early" PET-CT [12 + 2 days after the start of chemoradiation]

Outcome Time Frame:

PET-CT at 12 + 2 days after the start of chemoradiation

Safety Issue:


Principal Investigator

Jaffer Ajani

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2009

Completion Date:

Related Keywords:

  • Gastrointestinal Disease
  • Esophageal Cancer
  • Gastrointestinal
  • Esophagus
  • Cancer of the esophagus
  • Biopsy
  • EGD
  • Esophagogastroduodenoscopy
  • PET/CT
  • Positive Emission Tomography/Computerized Tomography
  • Esophageal Cancer
  • Chemoradiation
  • Chemotherapy
  • Radiation Therapy
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Gastrointestinal Diseases
  • Digestive System Diseases



UT MD Anderson Cancer Center Houston, Texas  77030