Spots Global Cancer Trial Database for Phase I Dose Escalation of Stereotactic Radiosurgical Boost for Locally Advanced Esophageal Cancer

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Trial Identification

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

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 ID: NCT00368329

Conditions

Esophageal Neoplasms

Carcinoma, Squamous Cell

Adenocarcinoma

Esophageal Cancer

Interventions

Capecitabine (Xeloda)

[18-F] Fluorodeoxyglucose (FDG)

5-Fluorouracil (5-FU)

Carboplatin

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.

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.