Positron Emission Tomography for Cancer of Esophagus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cancer of Esophagus+3 More
Positron Emission Tomography - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying PET scans to see if they help assess response in patients with esophageal cancer receiving chemotherapy.

Eligible Conditions
  • Cancer of Esophagus
  • Esophageal Neoplasms Malignant
  • Adenocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Up to 5 years

8 months
PFS among PET/CT non-responders within each induction treatment group
Up to 5 years
Complete Pathological Response (pCR) of PET/CT Non-responders
PET/CT Response Between Treatment Arms
Upper arm
Progression Free Survival (PFS) Among PET/CT Non-responders Within Each Induction Treatment Group
pCR Compared Among Non-responders Between Induction Treatment Arms if Treatment Regimens Are Found to be Efficacious
pCR Compared Between Induction Treatment Arms Among PET/CT Responders
pCR compared among non-responders between induction treatment arms if treatment regimens are found to be efficacious
pCR compared between induction treatment arms among PET/CT responders
Inverse PCR

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm I (FOLFOX regimen)
1 of 2
Arm II (carboplatin + paclitaxel + radiation)
1 of 2

Experimental Treatment

257 Total Participants · 2 Treatment Groups

Primary Treatment: Positron Emission Tomography · No Placebo Group · Phase 2

Arm I (FOLFOX regimen)Experimental Group · 8 Interventions: Oxaliplatin, Fluorouracil, Paclitaxel, Positron Emission Tomography, Computed Tomography, Radiation Therapy, Carboplatin, Leucovorin Calcium · Intervention Types: Drug, Drug, Drug, Procedure, Procedure, Radiation, Drug, Drug
Arm II (carboplatin + paclitaxel + radiation)Experimental Group · 3 Interventions: Paclitaxel, Radiation Therapy, Carboplatin · Intervention Types: Drug, Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
FDA approved
Fluorouracil
FDA approved
Paclitaxel
FDA approved
Positron Emission Tomography
2008
Completed Phase 2
~2820
Computed Tomography
2017
Completed Phase 2
~3410
Radiation Therapy
2005
Completed Phase 3
~7080
Carboplatin
FDA approved
Leucovorin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
498 Previous Clinical Trials
214,489 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,005 Previous Clinical Trials
41,301,670 Total Patients Enrolled
1 Trials studying Cancer of Esophagus
500 Patients Enrolled for Cancer of Esophagus
Karyn A. Goodman, MDStudy ChairMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
35 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a tumor that is surgically resectable and can be contained in a radiotherapy field
You have no evidence of distant metastases (as determined by EUS or PET/CT).
Patients with cervical, supraclavicular, or other nodal disease that is either not included in the radiation field or is not able to be resected at the time of esophagectomy are not eligible.
You have tissue available for central pathology review.
Patients must have an FDG-avid primary tumor with a maximum SUVmax of ≥ 5.
You have no known contraindication to the use of fluorouracil, taxanes, or platinum compounds.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: November 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.