Status:

TERMINATED

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

Lead Sponsor:

Stanford University

Conditions:

Esophageal Neoplasms

Carcinoma, Squamous Cell

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief 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...

Detailed Description

This study will evaluate the safety and feasibility of delivering radiation dose escalation using hypofractionated radiosurgery in locally advanced esophageal cancer. The dose escalation will be deliv...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

4 Patients enrolled

Trial Details

Trial ID

NCT00368329

Start Date

June 1 2006

End Date

March 1 2009

Last Update

July 16 2012

Active Locations (1)

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1

Stanford University School of Medicine

Stanford, California, United States, 94305