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

NCT ID: NCT00368329

Last Updated: 2012-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Esophageal Neoplasms Carcinoma, Squamous Cell Adenocarcinoma Esophageal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Capecitabine (Xeloda)

PO bid daily on RT days: 500mg \& 150mg tabs for dose 825mg/m2 bid AM/PM (total daily dose 1650mg/m2)

Intervention Type DRUG

[18-F] Fluorodeoxyglucose (FDG)

5-10 mCi IV administration

Intervention Type DRUG

5-Fluorouracil (5-FU)

200mg/m2 continuous venous infusion

Intervention Type DRUG

Carboplatin

AUC 2, based onCalvert formula IV infusion

Intervention Type DRUG

Other Intervention Names

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Xeloda Fluorodeoxyglucose 5-Fluorouracil Carac Efudix Efudex Fluoroplex cis-Diammine Paraplatin Paraplatin-AQ

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Daniel T. Chang

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel T Chang

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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96075

Identifier Type: OTHER

Identifier Source: secondary_id

ESOPH0001

Identifier Type: -

Identifier Source: org_study_id