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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Esophageal Neoplasms, Carcinoma, Squamous Cell, Adenocarcinoma, Esophageal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

A complete assessment of all pathologic specimens (biopsy and definitive surgical) to document the histology, grade, depth of invasion, lymphovascular or perineural invasion.

Outcome Time Frame:

unknown

Safety Issue:

No

Principal Investigator

Daniel T Chang

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

ESOPH0001

NCT ID:

NCT00368329

Start Date:

June 2006

Completion Date:

March 2009

Related Keywords:

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

Name

Location
Stanford University School of Medicine Stanford, California  94305-5317