FDG-PET-CT and Biomarkers in Esophageal Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00833625
First received: January 29, 2009
Last updated: December 12, 2012
Last verified: December 2012
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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:
MedlinePlus related topics:
CT Scans
Cancer
Digestive Diseases
Esophageal Cancer
Esophagus Disorders
Nuclear Scans
U.S. FDA Resources
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 2014 (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:
- 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 Criteria:
- 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.
Contacts and Locations
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 12, 2012 |
| 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 Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013