Back to resultsIMRT Tomotherapy for Esophagus Cancer (IMRT)
Primary Purpose
Esophagus Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IMRT
Sponsored by
About this trial
This is an interventional treatment trial for Esophagus Cancer focused on measuring IMRT
Eligibility 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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMRT + Concurrent chemotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in patients with unresectable esophagus cancer.
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
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
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
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
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
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.
Full Information
NCT ID
NCT00593723
First Posted
January 2, 2008
Last Updated
April 3, 2016
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00593723
Brief Title
IMRT Tomotherapy for Esophagus Cancer
Acronym
IMRT
Official Title
IMRT Tomotherapy for Esophagus Cancer: A Phase I Feasibility Study in Non-Operative Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer
Keywords
IMRT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMRT + Concurrent chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
IMRT
Primary Outcome Measure Information:
Title
The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in patients with unresectable esophagus cancer.
Description
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
Time Frame
One year after protocol registration
Secondary Outcome Measure Information:
Title
Evaluate local recurrence rates
Description
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.
Time Frame
Until patient progressive disease or death
Title
Evaluate disease-free survival rates
Description
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.
Time Frame
Until patient progressive disease or death
Title
Evaluate regional recurrence rates
Description
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.
Time Frame
Until patient progressive disease or death
Title
Evaluate distant recurrence rates
Description
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.
Time Frame
Until patient progressive disease or death
Title
Evaluate overall survival rates
Description
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.
Time Frame
Until patient progressive disease or death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Bradley, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
IMRT Tomotherapy for Esophagus Cancer
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