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Phase I Dose Escalation of Stereotactic Radiosurgical Boost for Locally Advanced Esophageal Cancer
Trial ID: NCT00368329
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.
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
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
drug: Capecitabine (Xeloda)
drug: [18-F] Fluorodeoxyglucose (FDG)
drug: 5-Fluorouracil (5-FU)
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Laurie Ann Columbo