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

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
Daniel T. Chang, Stanford University
ClinicalTrials.gov Identifier:
NCT00368329
First received: August 22, 2006
Last updated: July 13, 2012
Last verified: July 2012

August 22, 2006
July 13, 2012
June 2006
March 2009   (final data collection date for primary 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. [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • Patients' responses to therapy will be evaluated clinically after completion of their neoadjuvant chemoradiation. [ Time Frame: after completion of their neoadjuvant chemoradiation ] [ Designated as safety issue: No ]
  • 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.
Complete list of historical versions of study NCT00368329 on ClinicalTrials.gov Archive Site
  • Physical exam [ Time Frame: Once every three months for two years, then every six months for three years and then once a year. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Patterns of failure and the 2-year progression-free survival (PFS) rate. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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.
  • 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.
Not Provided
Not Provided
 
Phase I Dose Escalation of Stereotactic Radiosurgical Boost for Locally Advanced Esophageal Cancer
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

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Esophageal Neoplasms
  • Carcinoma, Squamous Cell
  • Adenocarcinoma
  • Esophageal Cancer
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00368329
ESOPH0001, 96075
Yes
Daniel T. Chang, Stanford University
Stanford University
Not Provided
Principal Investigator: Daniel T Chang Stanford University
Stanford University
July 2012

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