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

Completed · Phase 3

Conditions studied: Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Stage IB Esophageal Cancer AJCC v7, Stage IIA Esophageal Cancer AJCC v7, Stage IIB Esophageal Cancer AJCC v7, Stage IIIA Esophageal Cancer AJCC v7, Stage IIIB Esophageal Cancer AJCC v7

In brief

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.

Key facts

Study ID

NCT01196390

Run by

National Cancer Institute (NCI)

People needed

203

Starts

2011-02-14

Expected to finish

2023-08-15

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• PRIOR TO STEP 1 REGISTRATION BUT WITHIN 56 DAYS PRIOR TO STEP 2 REGISTRATION
• 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 cm
• 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
• CONDITIONS FOR PATIENT ELIGIBILITY PRIOR TO STEP 2 REGISTRATION (HER2-POSITIVE PATIENTS ONLY)
• 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 registration
• 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)

You may not qualify if…

• 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 patients
• 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

Where it is running

• The Kirklin Clinic at Acton Road — Birmingham, Alabama, United States
• Providence Hospital — Mobile, Alabama, United States
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States
• Alaska Women's Cancer Care — Anchorage, Alaska, United States
• Anchorage Oncology Centre — Anchorage, Alaska, United States
• Katmai Oncology Group — Anchorage, Alaska, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States
• Mercy San Juan Medical Center — Carmichael, California, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Enloe Medical Center — Chico, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Epic Care-Dublin — Dublin, California, United States
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Epic Care Partners in Cancer Care — Emeryville, California, United States
• Kaiser Permanente-Fremont — Fremont, California, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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