Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer

Not Recruiting

Trial ID: NCT01196390


This randomized phase III trial studies how well radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving radiation therapy and combination chemotherapy together with or without trastuzumab is more effective in treating esophageal cancer.

Official Title

A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma

Stanford Investigator(s)

Quynh-Thu Le, MD
Quynh-Thu Le, MD

Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine


Inclusion Criteria:

   - Pathologically confirmed primary adenocarcinoma of the esophagus that involves the mid
   (up to 25 cm), distal, or esophagogastric junction; the cancer may involve the stomach
   up to 5 cm

   - Endoscopy with biopsy


   - Intent to submit tissue for central HER2 testing

   - Stage T1N1-2, T2-3N0-2, according to the American Joint Committee on Cancer (AJCC) 7th
   edition staging, based on the following minimum diagnostic work-up:

      - Chest/abdominal/pelvic computed tomography (CT) or whole-body positron emission
      tomography (PET)/CT (NOTE: if CT is performed at this time point, whole-body
      PET/CT will be required prior to step 2 registration; PET/CT of skull base to
      mid-thigh is acceptable) (NOTE: if adenopathy is noted on CT or whole-body PET/CT
      scan, an endoscopic ultrasound is not required prior to STEP 2 registration as
      long as adequate tissue has been obtained for central HER2 testing)

      - Patients may have regional adenopathy including para-esophageal, gastric,
      gastrohepatic and celiac nodes; if celiac adenopathy is present, it must be =< 2

      - Patients with tumors at the level of the carina or above must undergo
      bronchoscopy to exclude fistula

   - Zubrod performance status 0-2

   - Absolute neutrophil count (ANC) >= 1,500 cells/mm^3

   - Platelets >= 100,000 cells/mm^3

   - Hemoglobin >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve
   hemoglobin [Hgb] >= 8.0 g/dL is acceptable)

   - Creatinine =< 2 times upper limit of normal

   - Bilirubin =< 1.5 times upper limit of normal

   - Aspartate aminotransferase (AST) =< 3.0 times upper limit of normal

   - For women of childbearing potential, a negative serum or urine pregnancy test

   - Patients must sign a study-specific informed consent prior to study entry


   - HER2 expressing adenocarcinoma of the esophagus centrally

   - Surgical consultation to confirm that patient will be able to undergo curative
   resection after completion of chemoradiation within 56 days prior to step 2

   - Radiation oncology consultation to confirm that disease can be encompassed in a
   radiotherapy field within 56 days prior to step 2 registration

   - Consultation with a medical oncologist within 56 days prior to step 2 registration

   - Stage T1N1-2, T2-3N0-2, according to the AJCC 7th edition staging, based upon the
   following minimum diagnostic work-up:

      - History/physical examination, with documentation of the patient's weight, within
      14 days prior to step 2 registration

      - Whole-body PET/CT scan within 56 days prior to step 2 registration (if only CT
      performed prior to step 1 registration)

      - Endoscopic ultrasound within 56 days prior to step 2 registration, unless the
      patient is found to have adenopathy per CT or whole-body PET/CT scan

      - Electrocardiogram (EKG) within 56 days prior to step 2 registration

      - Serum creatinine =< 2 x the upper limit or normal within 14 days prior to step 2

   - Zubrod performance status 0-2 within 14 days prior to step 2 registration

   - For women of childbearing potential, a negative serum pregnancy test within 14 days
   prior to step 2 registration

   - Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal by
   cardiac echocardiogram (echo) or multi gated acquisition (MUGA) scan within 56 days
   prior to step 2 registration

   - Women of childbearing potential and sexually active male participants must agree to
   practice adequate contraception while on study and for at least 60 days following the
   last dose of chemotherapy or trastuzumab

Exclusion Criteria:

   - Patients with cervical esophageal carcinoma

   - Patients with T1N0 disease, T4 disease, and proximal esophageal cancers (15-24 cm)

   - Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a
   different cancer is allowable

   - Prior radiation therapy for esophageal cancer or prior chest radiotherapy

   - Prior anthracycline or taxane

   - Evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi

   - Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free
   for a minimum of 2 years (e.g., carcinoma in situ of the breast, oral cavity, or
   cervix are permissible)

   - Medical contraindications to esophagectomy

   - Prior therapy with any agent targeting the HER2 pathway or human epidermal growth
   factor receptor 1 (HER1) (epidermal growth factor receptor [EGFR]) pathway

   - Prior therapy with trastuzumab

   - Prior allergic reaction to the study drugs involved in this protocol or to a
   monoclonal antibody

   - Previous history of congestive heart failure

   - Severe, active comorbidity, defined as follows:

      - Unstable angina in the last 6 months

      - Transmural myocardial infarction within the last 6 months

      - Acute bacterial or fungal infection requiring intravenous antibiotics at the time
      of registration

      - Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
      Control and Prevention (CDC) definition; note, however that human
      immunodeficiency virus (HIV) testing is not required for entry into this
      protocol; protocol-specific requirements may also exclude immunocompromised

   - Pregnant or nursing women or women of childbearing potential and men who are sexually
   active and not willing/able to use medically acceptable forms of contraception


radiation: radiation therapy

drug: paclitaxel

drug: carboplatin

other: Laboratory Biomarker Analysis

other: Quality-of-Life Assessment

procedure: Therapeutic Conventional Surgery

biological: Trastuzumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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