Positron Emission Tomography in Determining Stage of Esophageal Cancer

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00004867

Collaborator

National Cancer Institute (NCI) (NIH)

235

Enrollment

Locations

Arm

110

Duration (Months)

6.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to determine the stage of esophageal cancer.

PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 positron emission tomography determines tumor stage in patients with esophageal cancer.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Procedure: conventional surgery Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: fludeoxyglucose F 18 Drug: chemotherapy Radiation: Radiotherapy	N/A

Detailed Description

OBJECTIVES:

Primary Objective:

To evaluate whether FDG-PET imaging can detect lesions that would preclude surgery (esophagectomy) in patients found to be surgical candidates by standard imaging procedures.

Secondary Objective:

To use the collected data to generate hypotheses to be used in future studies, such as which types of previously undetected lesions FDG-PET imaging is best able to identify.

Study Design

Study Type:

Interventional

Actual Enrollment :

235 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Carcinoma of the Thoracic Esophagus

Study Start Date :

Nov 1, 1999

Actual Primary Completion Date :

Jul 1, 2005

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FDG-PET scan +/- neoadjuvant chemotherapy + surgery Patients receive fludeoxyglucose F 18 (FDG) IV followed 45-60 minutes later by positron emission tomography (PET) imaging. Confirmatory studies, such as biopsy or other imaging studies, are then conducted to confirm the FDG PET imaging results. Patients with no metastases identified by FDG PET imaging may undergo esophagectomy with or without neoadjuvant chemoradiotherapy within 1 month of evaluation. Patients are followed within 6 months after surgery.	Procedure: conventional surgery Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: fludeoxyglucose F 18 Drug: chemotherapy Radiation: Radiotherapy

Arm

Intervention/Treatment

Experimental: FDG-PET scan +/- neoadjuvant chemotherapy + surgery

Patients receive fludeoxyglucose F 18 (FDG) IV followed 45-60 minutes later by positron emission tomography (PET) imaging. Confirmatory studies, such as biopsy or other imaging studies, are then conducted to confirm the FDG PET imaging results. Patients with no metastases identified by FDG PET imaging may undergo esophagectomy with or without neoadjuvant chemoradiotherapy within 1 month of evaluation. Patients are followed within 6 months after surgery.

Procedure: conventional surgery

Procedure: positron emission tomography

Procedure: radionuclide imaging

Radiation: fludeoxyglucose F 18

Drug: chemotherapy

Radiation: Radiotherapy

Outcome Measures

Primary Outcome Measures

Proportion of these patients with FDG-PET findings that contraindicate surgery [Up to 1 month post-FDG-PET scan]

Secondary Outcome Measures

The proportion of false positive lesions found by FDG-PET. [Up to 6 months post-surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient must be ≥ 18 years of age.
Patient must have histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (greater than or equal to 20 cm from incisors) or gastroesophageal junction. (Pathology report must be submitted).
Patient must be deemed medically fit for surgical staging procedures and esophagectomy following the thoracic surgeon's evaluation of general medical fitness.
Patient's clinical staging data (clinical examination, laboratory tests, and standard radiological staging assessments) must be obtained within 60 days prior to registration and must suggest that the tumor is potentially resectable, including tumors staged T1-3, N0-1, M0.
Patient must be able to tolerate FDG-PET scan (e.g., not claustrophobic and able to lie supine for 1.5 hrs).
Female patient of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to FDG-PET.

NOTE: Pregnancy test is required to avoid unnecessary fetal radiation exposure and because the use of furosemide is contraindicated in pregnancy.

Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study related procedures.
Patient must provide written authorization to allow the use and disclosure of their protected health information.

NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study pre-registration.

A cancer survivor is eligible provided that ALL of the following criteria are met and documented:

the patient has undergone potentially curative therapy for all prior malignancies and
there has been no evidence of any prior malignancies for at least five years (except for completely resected cervical or non-melanoma skin cancer) and
the patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Exclusion Criteria:

Patient has proximal esophageal cancer (less than 20 cm from incisors) potentially requiring pharyngolaryngoesophagectomy.
Patient has unresectable lesions (stage M1b, with biopsy confirmation of distant metastatic disease; or those with unresectable locoregional invasion, T4 Nx Mx).
Patient has evidence of metastatic disease.

NOTE: Obvious metastasis that is based on clinical evaluation includes any or all of the following: positive cytology of pleura, pericardium, or peritoneum; metastasis to brain, bone, lung, liver, or adrenals; positive biopsy or cytology of metastasis to supraclavicular lymph nodes; and involvement of the tracheobronchial tree (positive bronchoscopic biopsy or overt esophago-respiratory fistula).

Patient has had a prior FDG-PET scan for evaluation of their esophageal cancer.
Patient has uncontrolled diabetes mellitus, as evidenced by a fasting blood glucose value >200 mg/dL, within 12 hours of FDG-PET scan.
Patient has received neoadjuvant chemotherapy and/or radiotherapy PRIOR to FDG-PET scan being performed.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Cancer Center at University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-3300
2	Mobile Infirmary Medical Center	Mobile	Alabama	United States	36640-0460
3	University of South Alabama Cancer Research Institute	Mobile	Alabama	United States	36688
4	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California	United States	90095-1781
5	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California	United States	92868
6	UCSF Comprehensive Cancer Center	San Francisco	California	United States	94115
7	Stanford Cancer Center at Stanford University Medical Center	Stanford	California	United States	94305-5407
8	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Aurora	Colorado	United States	80010
9	Morton Plant Hospital	Clearwater	Florida	United States	33756
10	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202
11	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland	United States	21201
12	Cancer Center at Greater Baltimore Medical Center	Baltimore	Maryland	United States	21204
13	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
14	William Beaumont Hospital - Royal Oak	Royal Oak	Michigan	United States	48073
15	Siteman Cancer Center at Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
16	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
17	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
18	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
19	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio	United States	44302
20	Bethesda North Hospital	Cincinnati	Ohio	United States	45242
21	Tri-Health Good Samaritan Hospital	Cincinnati	Ohio	United States	90027
22	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio	United States	43210-1240
23	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon	United States	97213-2967
24	Westmoreland Regional Hospital	Greensburg	Pennsylvania	United States	15601-2282
25	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212-4772
26	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital	Pittsburgh	Pennsylvania	United States	15224
27	St. Clair Memorial Hospital	Pittsburgh	Pennsylvania	United States	15243-1899
28	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
29	University of Tennessee, Memphis	Memphis	Tennessee	United States	38163
30	Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus	Nashville	Tennessee	United States	37212
31	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee	United States	37232-6838
32	Baylor University Medical Center	Dallas	Texas	United States	75246
33	LDS Hospital	Salt Lake City	Utah	United States	84143
34	Massey Cancer Center at Virginia Commonwealth University	Richmond	Virginia	United States	23298-0037
35	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98104