FLT PET/CT for Staging, Target Definition and Assessment of Response to Therapy in Patients With Esophageal Cancer



Status:Active, not recruiting
Conditions:Cancer, Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2010

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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

The purpose of this pilot study is to develop a more advanced software program that will
collect, compare and analyze tumor images for evaluation. Another purpose of this study is
to learn if a new radio-tracer for tumor imaging called 3'-deoxy-3'(18) F-fluorothymidine
(FLT) can improve the evaluation of tumors during a PET/CT scan. This new type of image
tracking is meant to improve the visualization of tumor active and size.

- 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
We found this trial at
3
sites
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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