FDG-PET-CT and Biomarkers in Esophageal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00833625
First received: January 29, 2009
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Gastrointestinal Disease
Esophageal Cancer
Procedure: PET/CT (FDG PET/CT)
Other: Biomarker Testings

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: FDG-PET-CT and Biomarkers to Assess Pathologic Response in Surgical Specimens of Patients With Localized Esophageal Cancer After Chemoradiation

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Pathologic Response [ Time Frame: PET-CT at 12 + 2 days after the start of chemoradiation ] [ Designated as safety issue: Yes ]
    From baseline PET-CT to "early" PET-CT [12 + 2 days after the start of chemoradiation]


Estimated Enrollment: 95
Study Start Date: February 2009
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833625

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jaffer Ajani UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00833625     History of Changes
Other Study ID Numbers: 2008-0752, PAR-08-147
Study First Received: January 29, 2009
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Gastrointestinal
Esophagus
Cancer of the esophagus
Biopsy
EGD
Esophagogastroduodenoscopy
PET/CT
Positive Emission Tomography/Computerized Tomography
Esophageal Cancer
Chemoradiation
Chemotherapy
Radiation Therapy

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on September 30, 2014