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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00368329
Recruitment Status : Terminated (low accrual)
First Posted : August 24, 2006
Last Update Posted : July 16, 2012
Information provided by (Responsible Party):
Daniel T. Chang, Stanford University

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.

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Carcinoma, Squamous Cell Adenocarcinoma Esophageal Cancer Drug: Capecitabine (Xeloda) Drug: [18-F] Fluorodeoxyglucose (FDG) Drug: 5-Fluorouracil (5-FU) Drug: Carboplatin Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Capecitabine (Xeloda)
    PO bid daily on RT days: 500mg & 150mg tabs for dose 825mg/m2 bid AM/PM (total daily dose 1650mg/m2)
    Other Name: Xeloda
  • Drug: [18-F] Fluorodeoxyglucose (FDG)
    5-10 mCi IV administration
    Other Name: Fluorodeoxyglucose
  • Drug: 5-Fluorouracil (5-FU)
    200mg/m2 continuous venous infusion
    Other Names:
    • 5-Fluorouracil
    • Carac
    • Efudix
    • Efudex
    • Fluoroplex
  • Drug: Carboplatin
    AUC 2, based onCalvert formula IV infusion
    Other Names:
    • cis-Diammine
    • Paraplatin
    • Paraplatin-AQ

Primary Outcome Measures :
  1. A complete assessment of all pathologic specimens (biopsy and definitive surgical) to document the histology, grade, depth of invasion, lymphovascular or perineural invasion.
  2. 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.
  3. Patients' responses to therapy will be evaluated clinically after completion of their neoadjuvant chemoradiation. [ Time Frame: after completion of their neoadjuvant chemoradiation ]

Secondary Outcome Measures :
  1. Physical exam [ Time Frame: Once every three months for two years, then every six months for three years and then once a year. ]
  2. 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. ]
  3. 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. ]
  4. Patterns of failure and the 2-year progression-free survival (PFS) rate. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00368329

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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Principal Investigator: Daniel T Chang Stanford University
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Responsible Party: Daniel T. Chang, PI, Stanford University Identifier: NCT00368329    
Other Study ID Numbers: ESOPH0001
96075 ( Other Identifier: Stanford University Alternate IRB Number )
First Posted: August 24, 2006    Key Record Dates
Last Update Posted: July 16, 2012
Last Verified: July 2012
Additional relevant MeSH terms:
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Esophageal Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Neoplasms, Squamous Cell
Fluorodeoxyglucose F18
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs