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Phase I Dose Escalation of Stereotactic Radiosurgical Boost for Locally Advanced Esophageal Cancer
Not Recruiting
Trial ID: NCT00368329
Purpose
To study the safety and feasibility of stereotactic radiation dose escalation following
neoadjuvant chemotherapy with concurrent conventionally fractionated radiation, by evaluating
the acute and late toxicity of treatment.
Official Title
Phase I Study of Dose Escalation Using Image-guided Radiotherapy to Deliver a Stereotactic Radiosurgical Boost After Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Esophageal Cancer
Stanford Investigator(s)
George A. Fisher Jr.
Colleen Haas Chair in the School of Medicine
Teri A Longacre
Richard L. Kempson, MD, Professor in Surgical Pathology
Eligibility
Inclusion Criteria:- Confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of
the esophagus by pathologist.
- Endoscopic ultrasound or CT evidence of tumor penetration through the esophageal wall
or involvement of regional lymph nodes, without evidence of distant metastasis
- No prior chest radiation therapy
- No prior chemotherapy for esophageal cancer
- Age greater than 18 years
- No infections requiring antibiotic treatment
- Able to care for self
- Patients must have acceptable liver, kidney and bone marrow function.
- The effects of the chemotherapy drugs on the developing human fetus are unknown. Women
of child-bearing potential and men must agree to use adequate contraception. Exclusion
Criteria:- Patients receiving any other investigational agents
- Evidence of distant metastases
- Uncontrolled medical illness
- Any malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix.
- Pregnant and breastfeeding women are excluded.
- HIV-positive patients
Intervention(s):
drug: Capecitabine (Xeloda)
drug: [18-F] Fluorodeoxyglucose (FDG)
drug: 5-Fluorouracil (5-FU)
drug: Carboplatin
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Laurie Ann Columbo
6507360792