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

Sponsor

Stanford University (Other)

Overall Status

Terminated

CT.gov ID

NCT00368329

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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 toxicity of treatment.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Neoplasms Carcinoma, Squamous Cell Adenocarcinoma Esophageal Cancer	Drug: Capecitabine (Xeloda) Drug: [18-F] Fluorodeoxyglucose (FDG) Drug: 5-Fluorouracil (5-FU) Drug: Carboplatin	Phase 1

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 delivered using an image-guided radiosurgical boost to the tumor volume, following a neoadjuvant regimen consisting of oxaliplatin, capecitabine, and conventionally fractionated radiotherapy. In addition, we will evaluate the utility of PET-FDG before and after neoadjuvant chemoradiation in predicting the pathologic response to pre-operative treatment. We will study the effect of this regimen on pathologic complete response rates and complete resection rates at surgery among patients with locally advanced esophageal cancer and determine patterns of failure and rates of progression-free survival. Finally, we plan to characterize in an exploratory manner the correlation between molecular markers and pathologic findings following pre-operative chemoradiation.

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Outcome Measures

Primary Outcome Measures

A complete assessment of all pathologic specimens (biopsy and definitive surgical) to document the histology, grade, depth of invasion, lymphovascular or perineural invasion. []
The inked margins on the definitive surgical specimen will be inked and margin status, size of the tumor, evidence of residual tumor will be recorded. []
Patients' responses to therapy will be evaluated clinically after completion of their neoadjuvant chemoradiation. [after completion of their neoadjuvant chemoradiation]

Secondary Outcome Measures

Physical exam [Once every three months for two years, then every six months for three years and then once a year.]
CT scan [Three months after completion of therapy, then every six months for three years then once a year for until 5 years from completion of therapy.]
Upper endoscopy [Three months after completion of therapy, then every six months for three years then once a year for until 5 years from completion of therapy.]
Patterns of failure and the 2-year progression-free survival (PFS) rate. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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