Phase I Dose Escalation of Stereotactic Radiosurgical Boost for Locally Advanced Esophageal Cancer

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Capecitabine; Carboplatin; Deoxyglucose; Fluorodeoxyglucose F18; Fluorouracil

Criteria

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