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Type(s) of Cancer
Esophageal,Gastrointestinal
Study Phase
Phase 3
Study Completion Date
December 2019
NCT01196390Uploaded 05-02-2023
Access via NCI by Request
PDS UID: nci-data-520
A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma
Provider Information
Provider Data DescriptionThis dataset, NCT01196390-D1, contains the baseline, treatment, survival, and toxicity data presented in the RTOG-1010 primary publication (PMID: 35038433). NCT01196390-D2 contains treatment-related adverse event data. NCT01196390-D3 contains treatment-related serious adverse event data.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsEsophageal 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
Intervention TypeDrug: Carboplatin
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Procedure: Therapeutic Conventional Surgery
Biological: Trastuzumab
Drug(s)Drug: Carboplatin
Drug: Paclitaxel
Total Enrolled203
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (radiotherapy, chemotherapy, trastuzumab) - Experimental
Arm II (radiotherapy and chemotherapy) - Experimental
Secondary IDNCI-2011-02601
PubMed (PMID)35038433
Collaborator(s)NRG Oncology
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Files: NCT01196390-D1
Data DictionaryNCT01196390-D1-Data-Dictionary_1.pdf
DATANCT01196390-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01196390-D2
Data DictionaryNCT01196390-D2-Data-Dictionary_1.pdf
DATANCT01196390-D2-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01196390-D3
Data DictionaryNCT01196390-D3-Data-Dictionary_1.pdf
DATANCT01196390-D3-Dataset_1.csv
OTHERREADME.pdf
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