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

NCT ID: NCT01243619

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-03-31

Brief Summary

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.

Detailed Description

• 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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FLT PET

This is a single arm trial, in which all patients receive three FDG-PET scans and three FLT-PET scans, before, during and after pre-operative chemoradiation for esophageal cancer.

Group Type: EXPERIMENTAL

3'-deoxy-3'-(18) F-fluorothymidine

Intervention Type: DRUG

Radio-tracer for tumor imaging

Interventions

3'-deoxy-3'-(18) F-fluorothymidine

Radio-tracer for tumor imaging

Intervention Type: DRUG

Other Intervention Names

FLT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Harvey Mamon, MD, PhD

Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harvey J. Mamon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber/Brigham and Women's Cancer Center

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

10-169

Identifier Type: -

Identifier Source: org_study_id