IMRT Tomotherapy for Esophagus Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Esophagus Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

IMRT

Intervention Type RADIATION

Interventions

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IMRT

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No