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
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

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. [ 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4
Study Start Date: June 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368329

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Daniel T Chang Stanford University
  More Information

No publications provided

Responsible Party: Daniel T. Chang, PI, Stanford University
ClinicalTrials.gov Identifier: NCT00368329     History of Changes
Other Study ID Numbers: ESOPH0001, 96075
Study First Received: August 22, 2006
Last Updated: July 13, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Esophageal Neoplasms
Adenocarcinoma
Carcinoma, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Capecitabine
Carboplatin
Fluorouracil
Deoxyglucose
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 16, 2014