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.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine

Teri A Longacre
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

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