Trial record 1 of 1 for:    NCT00593723
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IMRT Tomotherapy for Esophagus Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00593723
First received: January 2, 2008
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

Concurrent chemotherapy and radiation therapy are the standard of care for inoperable patients with esophagus cancer. Unfortunately, the 5-year survival of 20% for this population is quite low. Methods to intensify radiation therapy delivery without increasing local toxicities are needed. Intensity modulated radiation therapy (IMRT) is an advanced method of delivering external beam radiation that may minimize the volume of normal tissue irradiated to high dose and thus decrease the risk of normal tissue toxicity. The proposed study will prospectively test whether IMRT is tolerable for delivering IMRT doses of 60 Gy for patients with esophagus cancer.


Condition Intervention Phase
Esophagus Cancer
Radiation: IMRT
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IMRT Tomotherapy for Esophagus Cancer: A Phase I Feasibility Study in Non-Operative Patients

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in patients with unresectable esophagus cancer. [ Time Frame: One year after protocol registration ] [ Designated as safety issue: Yes ]

    The study will be deemed infeasible if one or more of the following results occur:

    • 15% of patients experience any grade 4 acute toxicity judged to be related to his/her external radiation treatment

      • within 1 year of protocol registration, >15% of patients develop any grade 4 late toxicity judged to be related to his/her external radiation treatment
      • within 1 year of protocol registration, any patient dies from causes judged to be related to his/her external beam radiation treatment


Secondary Outcome Measures:
  • Evaluate local recurrence rates [ Time Frame: Until patient progressive disease or death ] [ Designated as safety issue: No ]
    6 weeks after therapy, every 3 months for first two years post therapy, every 6 months for years 3, 4, and 5 post therapy, and then annually.

  • Evaluate disease-free survival rates [ Time Frame: Until patient progressive disease or death ] [ Designated as safety issue: No ]
    6 weeks after therapy, every 3 months for first two years post therapy, every 6 months for years 3, 4, and 5 post therapy, and then annually.

  • Evaluate regional recurrence rates [ Time Frame: Until patient progressive disease or death ] [ Designated as safety issue: No ]
    6 weeks after therapy, every 3 months for first two years post therapy, every 6 months for years 3, 4, and 5 post therapy, and then annually.

  • Evaluate distant recurrence rates [ Time Frame: Until patient progressive disease or death ] [ Designated as safety issue: No ]
    6 weeks after therapy, every 3 months for first two years post therapy, every 6 months for years 3, 4, and 5 post therapy, and then annually.

  • Evaluate overall survival rates [ Time Frame: Until patient progressive disease or death ] [ Designated as safety issue: No ]
    6 weeks after therapy, every 3 months for first two years post therapy, every 6 months for years 3, 4, and 5 post therapy, and then annually.


Enrollment: 26
Study Start Date: December 2006
Estimated Study Completion Date: November 2016
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMRT + Concurrent chemotherapy

180 cGy daily fractions to a total dose of 5400 cGy to PTV1 and 200 cGy daily fractions to a total dose of 6000 cGy to PTV2. Once a day, five days a week, for approximately 6 weeks.

Planned chemotherapy: cisplatin (75 mg/m2) day 1 and 5-FU (1000 mg/m2) days 1-4 on weeks 1, 5, 10, and 14 of therapy. Please note that drug regimens and doses may vary and will be at the discretion of the medical oncologist.

Radiation: IMRT

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18
  • Karnofsky Performance Status of >= 60
  • TNM Stages T1-4, N0-3, M0
  • Pathologic confirmation of esophagus cancer
  • Evaluation by medical oncologist determines that the patient is medically fit for concurrent chemotherapy
  • Evaluation by surgeon determines that patient is unresectable

Exclusion Criteria:

  • Age < 18
  • Karnofsky Performance Status < 60
  • Radiographic or pathologic evidence of distant metastatic disease (classified as M1b in AJCC staging manual)
  • Prior radiation therapy to the thorax or upper abdomen, preventing definitive radiation therapy.
  • Pregnant or lactating, if female.
  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: NCT00593723

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jeffrey Bradley, MD Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00593723     History of Changes
Other Study ID Numbers: 06-1070 / 201105499
Study First Received: January 2, 2008
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
IMRT

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2014