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

Stanford University

Status and phase

Terminated

Phase 1

Conditions

Carcinoma, Squamous Cell

Esophageal Cancer

Adenocarcinoma

Esophageal Neoplasms

Treatments

Drug: Capecitabine (Xeloda)

Drug: 5-Fluorouracil (5-FU)

Drug: [18-F] Fluorodeoxyglucose (FDG)

Drug: Carboplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00368329

ESOPH0001

96075 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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