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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.
 
ClinicalTrials.gov Identifier: NCT00368329
Recruitment Status : Terminated (low accrual)
First Posted : August 24, 2006
Last Update Posted : July 16, 2012
Sponsor:
Information provided by (Responsible Party):
Daniel T. Chang, Stanford University

Tracking Information
First Submitted Date  ICMJE August 22, 2006
First Posted Date  ICMJE August 24, 2006
Last Update Posted Date July 16, 2012
Study Start Date  ICMJE June 2006
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
  • 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. [ Time Frame: after completion of their neoadjuvant chemoradiation ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2006)
  • Patients' responses to therapy will be evaluated clinically after completion of their neoadjuvant chemoradiation.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
  • Physical exam [ Time Frame: Once every three months for two years, then every six months for three years and then once a year. ]
  • 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. ]
  • 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. ]
  • Patterns of failure and the 2-year progression-free survival (PFS) rate. [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2006)
  • Patterns of failure and the 2-year progression-free survival (PFS) rate.
  • Physical exam: Once every three months for two years, then every six months for three years and then once a year.
  • CT scans: 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Dose Escalation of Stereotactic Radiosurgical Boost for Locally Advanced Esophageal Cancer
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Esophageal Neoplasms
  • Carcinoma, Squamous Cell
  • Adenocarcinoma
  • Esophageal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 13, 2012)
4
Original Enrollment  ICMJE
 (submitted: August 23, 2006)
35
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00368329
Other Study ID Numbers  ICMJE ESOPH0001
96075 ( Other Identifier: Stanford University Alternate IRB Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel T. Chang, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel T Chang Stanford University
PRS Account Stanford University
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP