IMRT Tomotherapy for Esophagus Cancer

Esophagus Cancer Clinical Trial

— IMRT  

Official title:

IMRT Tomotherapy for Esophagus Cancer: A Phase I Feasibility Study in Non-Operative Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593723
• Other study ID #: 06-1070 / 201105499
• Status: Completed
• Phase: Phase 1
• First received: January 2, 2008
• Last updated: April 3, 2016
• Start date: December 2006
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Radiation:
• IMRT

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One year after protocol registration	Yes
Secondary	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.	Until patient progressive disease or death	No
Secondary	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.	Until patient progressive disease or death	No
Secondary	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.	Until patient progressive disease or death	No
Secondary	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.	Until patient progressive disease or death	No
Secondary	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.	Until patient progressive disease or death	No

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine