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

Trial ID or NCT#

NCT00368329

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus by pathologist.
    1. * 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:
  1. - 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
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Investigator(s)

Edward Graves
Jeffrey Norton, MD
Lei Xing
George A. Fisher Jr.
George A. Fisher Jr.
Medical oncologist, Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine
Teri A Longacre
Teri A Longacre
Pathologist, Surgical pathologist, Immunodiagnosis pathologist
Richard L. Kempson, MD, Professor in Surgical Pathology

Contact us to find out if this trial is right for you.

Contact

Laurie Ann Columbo
6507360792

View on ClinicalTrials.gov