Back to resultsPhase I Dose Escalation of Stereotactic Radiosurgical Boost for Locally Advanced Esophageal Cancer
Primary Purpose
Esophageal Neoplasms, Carcinoma, Squamous Cell, Adenocarcinoma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Capecitabine (Xeloda)
[18-F] Fluorodeoxyglucose (FDG)
5-Fluorouracil (5-FU)
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Neoplasms
Eligibility 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
Sites / Locations
- Stanford University School of Medicine
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Physical exam
CT scan
Upper endoscopy
Patterns of failure and the 2-year progression-free survival (PFS) rate.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00368329
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 Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
June 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms, Carcinoma, Squamous Cell, Adenocarcinoma, Esophageal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Capecitabine (Xeloda)
Other Intervention Name(s)
Xeloda
Intervention Description
PO bid daily on RT days: 500mg & 150mg tabs for dose 825mg/m2 bid AM/PM (total daily dose 1650mg/m2)
Intervention Type
Drug
Intervention Name(s)
[18-F] Fluorodeoxyglucose (FDG)
Other Intervention Name(s)
Fluorodeoxyglucose
Intervention Description
5-10 mCi IV administration
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil (5-FU)
Other Intervention Name(s)
5-Fluorouracil, Carac, Efudix, Efudex, Fluoroplex
Intervention Description
200mg/m2 continuous venous infusion
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
cis-Diammine, Paraplatin, Paraplatin-AQ
Intervention Description
AUC 2, based onCalvert formula IV infusion
Primary Outcome Measure Information:
Title
A complete assessment of all pathologic specimens (biopsy and definitive surgical) to document the histology, grade, depth of invasion, lymphovascular or perineural invasion.
Title
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.
Title
Patients' responses to therapy will be evaluated clinically after completion of their neoadjuvant chemoradiation.
Time Frame
after completion of their neoadjuvant chemoradiation
Secondary Outcome Measure Information:
Title
Physical exam
Time Frame
Once every three months for two years, then every six months for three years and then once a year.
Title
CT scan
Time Frame
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.
Title
Upper endoscopy
Time Frame
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.
Title
Patterns of failure and the 2-year progression-free survival (PFS) rate.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel T Chang
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase I Dose Escalation of Stereotactic Radiosurgical Boost for Locally Advanced Esophageal Cancer
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