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COMPLETED

NCT01196390

PHASE3

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

203

Start Date

2011-02-14

Completion Date

2023-08-15

Last Updated

2026-06-02

Healthy Volunteers

Conditions

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

Interventions

DRUG

Carboplatin

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Paclitaxel

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

RADIATION

Radiation Therapy

Undergo radiation therapy

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

BIOLOGICAL

Trastuzumab

Given IV

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 * 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) * 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 registration * 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 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

Locations (634)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

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

Fresno Cancer Center

Fresno, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

Marin General Hospital

Greenbrae, California, United States

Los Angeles County-USC Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Memorial Medical Center

Modesto, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

El Camino Hospital

Mountain View, California, United States

Sutter Cancer Research Consortium

Novato, California, United States

Highland General Hospital

Oakland, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Hematology and Oncology Associates-Oakland

Oakland, California, United States

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Valley Medical Oncology Consultants

Pleasanton, California, United States

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Kaiser Permanente-Redwood City

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Rohnert Park Cancer Center

Rohnert Park, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

South Sacramento Cancer Center

Sacramento, California, United States

Kaiser Permanente - Sacramento

Sacramento, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Doctors Medical Center- JC Robinson Regional Cancer Center

San Pablo, California, United States

Kaiser Permanente-San Rafael

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Saint Helena Hospital

St. Helena, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Vacaville, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Porter Adventist Hospital