FDG-PET-CT and Biomarkers in Esophageal Cancer

October 26, 2016 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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 hours.

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 collect 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 Anderson.

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 analysis.
  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 excluded.
  5. Patients with T1N0 or T4anyN are excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET/CT Scan + Biomarkers Testing

PET/CT scan with fluorodeoxyglucose (FDG) solution by vein, scan done 10-14 days after beginning chemotherapy and radiation (chemoradiation).

Tissue obtained at MDACC during previous biopsy and at time of post chemoradiation surgery will be used for biomarker analysis.
Procedure: PET/CT (FDG PET/CT)
PET/CT scan with fluorodeoxyglucose (FDG) solution by vein, scan done 10-14 days after beginning chemotherapy and radiation (chemoradiation).
Other Names:
  • Positron emission tomography/computed tomography
Other: Biomarker Testings
Tissue obtained at MDACC during previous biopsy and at time of post chemoradiation surgery will be used for biomarker analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic Response
Time Frame: PET-CT at 12 + 2 days after the start of chemoradiation
From baseline PET-CT to "early" PET-CT [12 + 2 days after the start of chemoradiation] Frequency and percentage of pathologic complete response (pathCR) and extreme chemoradiation resistance (exCRTR) patients tabulated. Exploratory graphics, such as box plots, used to illustrate distribution of PET/CT maximum SUV by pathCR (or exCRTR) status. A logistic regression model fit for pathCR (and separately, for exCRTR), with baseline and the change of maximum SUV between baseline and early chemoradiation included as covariates.
PET-CT at 12 + 2 days after the start of chemoradiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jaffer Ajani, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

February 2, 2009

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0752
  • PAR-08-147
  • NCI-2012-01614 (Registry Identifier: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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