PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy
RATIONALE: PET scans done during chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment.
PURPOSE: This randomized phase II trial is studying PET scan imaging in assessing response in patients with esophageal cancer receiving combination chemotherapy.
Adenocarcinoma of the Gastroesophageal Junction
Drug: FOLFOX regimen
Drug: leucovorin calcium
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer|
- pCR rate of PET/CT non-responders within each induction treatment group [ Designated as safety issue: No ]
- PET/CT response between treatment arms [ Designated as safety issue: No ]
- pCR rate among induction treatment PET/CT scan responders [ Designated as safety issue: No ]
- PFS and OS at 8 months [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Experimental: Arm I
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 radiotherapy (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.
Drug: FOLFOX regimen
Given IVDrug: fluorouracil
Given IVDrug: leucovorin calcium
Given IVDrug: oxaliplatin
Experimental: Arm II
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.
Given IVDrug: paclitaxel
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01333033
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|Principal Investigator:||Karyn A. Goodman, MD||Memorial Sloan-Kettering Cancer Center|