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

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00368329
• Other study ID #: ESOPH0001
• Secondary ID: 96075
• Status: Terminated
• Phase: Phase 1
• First received: August 22, 2006
• Last updated: July 13, 2012
• Start date: June 2006
• Est. completion date: March 2009

Study information

• Verified date: July 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Capecitabine (Xeloda)
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)
5-10 mCi IV administration
• 5-Fluorouracil (5-FU)
200mg/m2 continuous venous infusion
• Carboplatin
AUC 2, based onCalvert formula IV infusion

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A complete assessment of all pathologic specimens (biopsy and definitive surgical) to document the histology, grade, depth of invasion, lymphovascular or perineural invasion.		unknown	No
Primary	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.		unknown	No
Primary	Patients' responses to therapy will be evaluated clinically after completion of their neoadjuvant chemoradiation.		after completion of their neoadjuvant chemoradiation	No
Secondary	Physical exam		Once every three months for two years, then every six months for three years and then once a year.	No
Secondary	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.	No
Secondary	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.	No
Secondary	Patterns of failure and the 2-year progression-free survival (PFS) rate.		2 years	No