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Completed

NCT Number: NCT00593723

IMRT Tomotherapy for Esophagus Cancer

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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Key information

Conditions

Esophagus Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMRT

Radiation

Primary outcomes

  1. 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

    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 outcomes

  1. Evaluate local recurrence rates

    Time frame: Until patient progressive disease or death

    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.

  2. Evaluate disease-free survival rates

    Time frame: Until patient progressive disease or death

    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.

  3. Evaluate regional recurrence rates

    Time frame: Until patient progressive disease or death

    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.

  4. Evaluate distant recurrence rates

    Time frame: Until patient progressive disease or death

    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.

  5. Evaluate overall survival rates

    Time frame: Until patient progressive disease or death

    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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: IMRT

Important dates

Study start
2006
Primary completion
2014
Study completion
2015
First posted
Jan 15, 2008
Registry last updated
Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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