IMRT Tomotherapy for Esophagus Cancer

The Washington University

Status and phase: Completed; Phase 1

Conditions: Esophagus Cancer

Treatments: Radiation: IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT00593723

06-1070 / 201105499

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

IMRT + Concurrent chemotherapy

Experimental group

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.

Treatment:

Radiation: IMRT