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| ID | Type | Description | Link |
|---|---|---|---|
| 96075 | Other Identifier | Stanford University Alternate IRB Number |
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low accrual
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine (Xeloda) | Drug | PO bid daily on RT days: 500mg & 150mg tabs for dose 825mg/m2 bid AM/PM (total daily dose 1650mg/m2) |
| |
| [18-F] Fluorodeoxyglucose (FDG) | Drug | 5-10 mCi IV administration |
| |
| 5-Fluorouracil (5-FU) | Drug | 200mg/m2 continuous venous infusion |
| |
| Carboplatin | Drug | AUC 2, based onCalvert formula IV infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:- Confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus by pathologist.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel T Chang | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| 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 |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D019788 | Fluorodeoxyglucose F18 |
| D005472 | Fluorouracil |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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