Overview

This trial is active, not recruiting.

Condition esophagus cancer
Treatment imrt
Phase phase 1
Sponsor Washington University School of Medicine
Start date December 2006
End date January 2014
Trial size 26 participants
Trial identifier NCT00593723, 06-1070 / 201105499

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
imrt

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Evaluate local recurrence rates
time frame: Until patient progressive disease or death
Evaluate disease-free survival rates
time frame: Until patient progressive disease or death
Evaluate regional recurrence rates
time frame: Until patient progressive disease or death
Evaluate distant recurrence rates
time frame: Until patient progressive disease or death
Evaluate overall survival rates
time frame: Until patient progressive disease or death

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title IMRT Tomotherapy for Esophagus Cancer: A Phase I Feasibility Study in Non-Operative Patients
Principal investigator Jeffrey Bradley, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.