PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy
Condition: Adenocarcinoma of the Gastroesophageal Junction; Esophageal Cancer
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Intervention: Oxaliplatin; Leucovorin Calcium; Fluorouracil; Carboplatin; Paclitaxel; Positron Emission Tomography; Computed Tomography; Radiation Therapy
Intervention description: Given IV; Given IV; Given IV; Given IV; Given IV; Undergo PET/CT scan; Undergo PET/CT scan; Undergo RT
Intervention MeSH terms: Leucovorin; Paclitaxel; Carboplatin; Fluorouracil; Oxaliplatin; Calcium; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 257.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the gastroesophageal junction; adenocarcinoma of the esophagus; stage IB esophageal cancer; stage IIA esophageal cancer; stage IIB esophageal cancer; stage IIIA esophageal cancer; stage IIIB esophageal cancer; stage IIIC esophageal cancer

Summary:

      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.
    

Eligibility criteria:

        -  Surgically resectable, histologically confirmed esophageal adenocarcinoma, including
             Siewert gastroesophageal (GE) junction adenocarcinomas types 1 and 2

          -  T1N1-3M0 or T2-4NanyM0 as determined by endoscopic ultrasound (EUS) and PET/CT
             (histologic confirmation of lymph involvement is not required); all disease (tumor and
             nodes) must be both surgically resectable and capable of containment in a radiotherapy
             field; no T4 tumor with clear evidence of invasion of the vertebral column, heart,
             great vessels, or tracheobronchial tree

          -  All patients must have locoregional staging determined by endoscopic ultrasound (EUS)
             if technically feasible; endoscopy reports or subsequent gastrointestinal (GI) clinic
             note should clearly state both the T and N stage

          -  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

          -  Patient must have pre-resection tissue available for central pathology review, in case
             that the patient has a pCR at the time of surgical resection to confirm diagnosis

          -  Patients must have an fludeoxyglucose F 18 (FDG)-avid tumor with a maximum standard
             uptake value (SUVmax) of >= 5.0 on baseline PET/CT scan of primary tumor; baseline
             PET/CT scan should be performed; if it is necessary to repeat baseline PET/CT scan,
             reimbursement information is available

          -  No prior malignancy within 5 years of registration, with the exception of basal or
             squamous cell skin cancers, or in situ bladder or cervical cancer; patients with prior
             malignancy treated with surgery only and disease free for more than 5 years are
             eligible; however, no prior thoracic radiation therapy (RT) or abdominal RT or
             chemotherapy allowed

          -  No known contraindication to the use of fluorouracil, taxanes, or platinum compounds

          -  No history of severe hypersensitivity reaction to Cremophor EL

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Patient must be non-pregnant and non-nursing; women of child bearing potential must
             have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or
             equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to
             randomization; women of child-bearing potential include any female who has experienced
             menarche and who has not undergone surgical sterilization (hysterectomy, bilateral
             tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as
             amenorrhea >= 12 consecutive months; or women on hormone replacement therapy [HRT]
             with documented serum follicle stimulating hormone [FSH] level > 35mIU/mL); even women
             who are using oral, implanted or injectable contraceptive hormones or mechanical
             products such as an intrauterine device or barrier methods (diaphragm, condoms,
             spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile
             (e.g., vasectomy), should be considered to be of child bearing potential

          -  Absolute neutrophil count (ANC) >= 1,500/μL

          -  Platelet count >= 100,000/μL

          -  Bilirubin =< 1.5 times upper limit of normal (ULN)

          -  Calculated creatinine clearance >= 60 mL/min

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 times ULN