Study of 5-FU, Oxaliplatin, & Lapatinib Combined With Radiation Therapy to Treat HER2 Positive Esophagogastric Cancer
Public ClinicalTrials.gov record NCT01769508. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase II Study With Lead-in Safety Cohort of 5-Fluorouracil, Oxaliplatin and Lapatinib in Combination With Radiation Therapy as Neoadjuvant Treatment for Patients With Localized HER2 Positive Esophagogastric Adenocarcinomas
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
With improvements in response rate and survival seen for HER2 positive patients treated with HER2 blockade in the metastatic setting, the use of HER2 blockade in the neoadjuvant setting to increase antitumor effect shows promise. Patients with previously untreated localized HER2 positive esophageal, GE junction and gastric adenocarcinomas will be enrolled. Patients meeting all inclusion/exclusion criteria will receive neoadjuvant treatment with concurrent chemotherapy and radiation therapy beginning on day 1 of treatment. During the lead-in safety portion, the optimal dose of lapatinib will be determined.
Study identification
- NCT ID
- NCT01769508
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Interventions
- 5-Fluorouracil Drug
- Oxaliplatin Drug
- Lapatinib Drug
- Radiation Therapy Radiation
Drug · Radiation
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2013 (Type not available)
- Primary completion
- Feb 2014 (Actual)
- Completion
- Feb 2015 (Actual)
- Last update posted
- Jun 13, 2016
2013 – 2015
United States locations
- U.S. sites
- 9
- U.S. states
- 5
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Florida Cancer Specialists - South | Fort Myers | Florida | 33916 | — |
| Florida Hospital Cancer Institute | Orlando | Florida | 32804 | — |
| Woodlands Medical Specialists | Pensacola | Florida | 32503 | — |
| Florida Cancer Specialists-North | St. Petersburg | Florida | 33705 | — |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | — |
| Grand Rapids Oncology Program | Grand Rapids | Michigan | 49503 | — |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | — |
| Chattanooga Oncology and Hematology Associates | Chattanooga | Tennessee | 37404 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01769508, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 13, 2016 · Synced Nov 9, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01769508 live on ClinicalTrials.gov.