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3'-Deoxy-3'(18) F-Fluorothymidine Positron Emission Tomography/Computed Tomography (PET/CT) for Initial Staging, Radiotherapy Target Definition, and Assessment of Response to Therapy in Patients With Esophageal Cancer: A Pilot Study

18 Years
Open (Enrolling)
Esophageal Cancer

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Trial Information

3'-Deoxy-3'(18) F-Fluorothymidine Positron Emission Tomography/Computed Tomography (PET/CT) for Initial Staging, Radiotherapy Target Definition, and Assessment of Response to Therapy in Patients With Esophageal Cancer: A Pilot Study

- The following are standard medical procedures that are part of regular cancer care that
the participant would probably have done even if they did not join the study:
Chemotherapy; physical examination; pregnancy test (if applicable); diagnostic
FDG-PET/CT scan before and after treatment to evaluate disease.

- The following diagnostic procedures are being done specifically because of this study:
Three FLT-PET/CT scans before, during and after treatment and one FDG PET/CT scan
during treatment.

- Participants will be in this research study for approximately 12-14 weeks.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the esophagus or
gastroesophageal junction. Biopsy or cytology of the primary tumor, or of involved
regional lymph nodes, is acceptable.

- Tumors must be TNM stage T2-4, N0-1, M0 as determined by pretreatment endoscopic
ultrasound. T1 tumors are eligible if they are T1, N1, M0. Regional thoracic lymph
node involvement is permitted.

- Disease must be clinically limited to the esophagus or gastroesophageal junction. If
the tumor extends below the gastroesophageal junction into the proximal stomach, 50%
of the tumor must involve the distal esophagus or gastroesophageal junction.
Adenocarcinomas of the distal esophagus would therefore include tumors of the
gastroesophageal junction which involve equally both the distal esophagus and
proximal stomach, or Siewert type II. Tumor much be surgically resectable and have a
minimum length of 2cm.

- Patients must be judged by their oncologist to be a candidate for combined modality
therapy with chemotherapy consisting of oxaliplatin with protracted infusion 5-FU and
concurrent radiation.

- FDG PET/CT performed off-site must be available for review by the Overall PI in DICOM
format and has been performed within one month of study entry

- 18 years of age or older

- ECOG Performance Status 0-1

- Laboratory values as outlined in the protocol

Exclusion Criteria:

- No prior chemotherapy or radiotherapy is permitted. Patients must be at least 4
weeks since major surgery, or must have recovered from the effects of minor surgery.

- No prior malignancies (other than basal cell or squamous cell carcinoma of the skin,
in situ cervical carcinoma, or superficial transitional cell bladder carcinoma) are
permitted unless diagnosed and/or treated 3 years or longer before registration and
without evidence of recurrence.

- Patients with the following tumor characteristics are not eligible: TIS (in situ
carcinoma); tumors determined to be T1N0 following endoscopic ultrasound;
supraclavicular (for distal tumors) or celiac (for proximal tumors) lymph node
involvement, as determined by EUS, CT scan, or PET scan, unless this is proven to be
a false positive by an appropriate biopsy; cervical esophageal tumors, or gastric
cancers with minor involvement of the gastroesophageal junction or distal esophagus;
no patients with tracheoesophageal fistulas

- Patients with evidence of metastatic disease

- No poorly controlled diabetes despite attempts to improve glucose control by fasting
duration and adjustment of medications

- Pregnant and breast feeding women are excluded

- HIV-positive individuals on combination antiretroviral therapy are ineligible

Type of Study:


Study Design:

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

Outcome Measure:

Determine possibility of acquiring three sets of serial PET scans, and importing the images for analysis.

Outcome Description:

Determine the possibility of aquiring three sets of serial Positron emission tomography (PET) scans from 5 patients at designated time points and to develop a mechanism to import and analyze images from F-fluoro-3'-deoxy-3'-L-fluorothymidine (FLT)-PET, F-Fluorodeoxyglucose(FDG)-PET and Computed Tomography (CT) on a single advanced software platform with deformable image registration capability. We will report patient acceptance of and compliance with this regimen, as well as the utility of the software platform for conducting the proposed analysis.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Harvey J. Mamon, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital/Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • PET
  • CT
  • radiotherapy
  • Esophageal Diseases
  • Esophageal Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617