Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer
NCT ID: NCT00165490
Last Updated: 2014-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
19 participants
INTERVENTIONAL
2004-08-31
2014-11-30
Brief Summary
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Detailed Description
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* Outpatient therapy with cetuximab alone will be given intravenously on week 0.
* During week 1-8 outpatient radiation therapy will be started and continued once per day for 28 treatments or 5 1/2 weeks.
* Outpatient chemotherapy (cisplatin, irinotecan and cetuximab) is given once per week on weeks 1, 2, 4, and 5. Cetuximab alone will be given on weeks 3, 6, 7, and 8.
* A repeat CT scan and PET scan will be performed to restage the tumor on week 8. This is to confirm that the cancer has remained localized.
* Inpatient surgery is scheduled 4 to 8 weeks after completion of chemotherapy and radiation therapy.
* Cetuximab will be restarted within 4 weeks after surgery and continue weekly for 6 months.
* During chemotherapy and radiation therapy, physical exams and vital signs will be performed before each chemotherapy treatment. Routine blood tests will also be performed.
* Between chemotherapy-radiation therapy and surgery a CAT scan of chest, abdomen and pelvis along with a PET scan will be performed.
* After surgery a CAT scan of chest, abdomen and pelvis will be performed every 3 months for 2 years then every 6 months for 3 years. An EGD (upper endoscopy) with biopsy will be done every 6 months for 2 years and then yearly for 3 years. Physical exam, vital signs and routine blood tests will be done every 2 weeks for 6 months, then every 3 months for 1.5 years, and then every 6 months for 3 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Cetuximab
Given once per week on weeks 1-8 and restarted 4 weeks after surgery, once weekly for 6 months.
Cisplatin
Given once per week on weeks 1, 2, 4,and 5.
Irinotecan
Given once per week on weeks 1, 2, 4,and 5.
Radiation therapy
Once daily for 28 treatments (5 1/2 weeks)
Surgery
Surgery performed 4-8 weeks after chemoradiation therapy.
Eligibility Criteria
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Inclusion Criteria
* Negative pregnancy test
* Adenocarcinoma or squamous cell carcinoma of the esophagus, including the gastroesophageal junction, histologically confirmed, stage IIA, IIB and III.
* ECOG performance status of 0 or 1.
* Neutrophils greater or equal to 1,500/ul
* Platelets greater or equal to 100,000/ul
* Serum bilirubin less or equal to 1.5mg/ul
* Serum creatinine less or equal to 1.5mg/ul
* AST or SGOT less or equal to 2.5x upper normal limit
* Alkaline phosphatase less or equal to 5x upper normal limit
Exclusion Criteria
* Prior chemotherapy or radiation therapy
* Biopsy proven tumor invasion of the tracheobronchial tree or tracheo-esophageal fistula.
* Metastatic disease to distant organs or non-regional lymph nodes.
* Co-morbid disease that in the opinion of the investigator makes combined chemo-radiotherapy inadvisable.
* Pregnant or lactating women
* Other active malignancy
* Patients with known Gilbert's Disease or interstitial pulmonary fibrosis.
* History of seizure disorder
* Uncontrolled diarrhea
* Peripheral neuropathy (Grade 2)
* Prior cetuximab or other therapy that specifically and directly targets the EGF pathway.
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Peter C. Enzinger, MD
Overall PI
Principal Investigators
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Peter Enzinger, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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02-012
Identifier Type: -
Identifier Source: org_study_id