Clinical Trial · NCT01243619

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

Overview

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.

Sponsor

Dana-Farber Cancer Institute

Phase

N/A

Contacts

Harvey J. Mamon, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01243619

Drug / Compound

fluorothymidine

Isotope(s):

Target(s):

cytosolic thymidine kinase 1

Ligand Class: Small Molecules

Eligibility

Inclusion

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
ECOG Performance Status 0-1
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.
Laboratory values as outlined in the protocol
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.
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.

Exclusion

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.
HIV-positive individuals on combination antiretroviral therapy are ineligible
Pregnant and breast feeding women are excluded
No poorly controlled diabetes despite attempts to improve glucose control by fasting duration and adjustment of medications
Patients with evidence of metastatic disease
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