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Anti-metabolites

Positron Emission Tomography for Esophageal Cancer

Phase 2
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial uses PET scans to monitor how well chemotherapy is working in patients with esophageal cancer. If the treatment isn't effective, patients switch to a different chemotherapy regimen. The goal is to find the best treatment plan for each patient based on their response.

Eligible Conditions
  • Esophageal Cancer
  • Gastroesophageal Junction Adenocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete Pathological Response (pCR) of PET/CT Non-responders
Secondary study objectives
PET/CT Response Between Treatment Arms
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
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (carboplatin + paclitaxel + radiation)Experimental Treatment3 Interventions
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases \>= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT
Group II: Arm I (FOLFOX regimen)Experimental Treatment8 Interventions
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by \>= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
2011
Completed Phase 4
~2890
Fluorouracil
2014
Completed Phase 3
~11700
Paclitaxel
2011
Completed Phase 4
~5810
Positron Emission Tomography
2011
Completed Phase 2
~2200
Computed Tomography
2017
Completed Phase 2
~2740
Radiation Therapy
2017
Completed Phase 3
~7250
Carboplatin
2014
Completed Phase 3
~6120
Leucovorin Calcium
2011
Completed Phase 3
~12500

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,215 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,743 Total Patients Enrolled
Karyn A. Goodman, MDStudy ChairMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
35 Total Patients Enrolled
~18 spots leftby Sep 2025
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