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Early Prediction of Pathology Response of Chemoradiotherapy With Fluoro-L-Thymidine (FLT) Positron Emission Tomography (PET)

18 Years
Open (Enrolling)
Esophageal Cancer

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Trial Information

Early Prediction of Pathology Response of Chemoradiotherapy With Fluoro-L-Thymidine (FLT) Positron Emission Tomography (PET)

The goal of this study is to obtain preliminary data and initial estimates of the FLT
ability(FluoroLThymidine)-PET (Positron Emission Tomography) to identify pathCR (pathologic
complete response) patients who have esophageal carinoma and undergo Chemo-RT prior to
surgery. Despite improvements in surgical management, long-term survival rates in patients
with esophageal cancer have not changed dramatically. Achievement in pathCR after
pre-operative CRT (chemoradiotherapy) is associated with improved patient outcomes; however,
there is no effective method to predict pathological response before surgery. Thus, a
patient with pathCR, for whom esophagectomy may be unnecessary, still undergoes surgery and
faces the prohibitive side effects of this surgical procedure. Additionally, CRT is
associated with considerable morbidities and tool to predict and avoid ineffective therapy
are lacking. Because deregulated proliferation is one of the hallmarks of cancer and its
proliferation rate is associated with aggressive biologic behavior and response to therapy,
imaging the proliferative state of cancer cells by noninvasive functional imaging is of
great interest. Recently 18F-FLT (3'deoxy33'-18F-fluorothymidine) has been reported as a
promising PET radiopharmaceutical for imaging cancer proliferation and has been validated in
several in vitro & in vivo models. However, only a few studies addressed its role in
depicting changes in cancer proliferation and assessing response to CRT, and none of these
studies have focused on esophageal cancer. We propose to conduct a pilot study to learn the
optimal FLT PET imaging timepoint during the early course of CRT that has the highest
predictive value for pathCR in patients with esophageal cancer.

Inclusion Criteria:

Patients with histologically diagnosed adenocarcinoma or squamous cell carcinoma of the
esophagus and localregional disease (stages II and III) will be eligible for participation
in this study.

Exclusion Criteria:

Patients with abnormal liver or renal function or peripheral neuropathy, and women with
pregnancy or breastfeeding will be excluded.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Determine optimal timepoint during CRT that FLT-PET imaging can predict response

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

K.S. Clifford Chao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Food and Drug Administration

Study ID:




Start Date:

August 2009

Completion Date:

August 2014

Related Keywords:

  • Esophageal Cancer
  • Esophageal cancer
  • Chemoradiotherapy
  • Esophageal Diseases
  • Esophageal Neoplasms



Columbia University Medical Center New York, New York  10032