NCT00368329

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Neoplasms
• Carcinoma, Squamous Cell
• Adenocarcinoma
• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine (Xeloda)	PO bid daily on RT days: 500mg \& 150mg tabs for dose 825mg/m2 bid AM/PM (total daily dose 1650mg/m2)
DRUG	[18-F] Fluorodeoxyglucose (FDG)	5-10 mCi IV administration
DRUG	5-Fluorouracil (5-FU)	200mg/m2 continuous venous infusion
DRUG	Carboplatin	AUC 2, based onCalvert formula IV infusion

Timeline

• Start date: 2006-06-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2006-08-24
• Last updated: 2012-07-16

Locations

1 site across 1 country: United States