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Proton Beam Radiation Therapy in Treating Patients With Recurrent Thoracic Cancer Who Have Received Prior Radiation Therapy

Published: September 24, 2014

 

Primary Outcome Measure:

  • Grade 3 or greater toxicity attributable to radiation treatment [ Time Frame: Up to 3 months post-treatment ] [ Designated as safety issue: Yes ]
    Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0.

Secondary Outcome Measures:

  • Local control [ Time Frame: Up to 3 months post-treatment ] [ Designated as safety issue: No ]
    Failure: tumor progression per Response Evaluation Criteria In Solid Tumors criteria – at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions inside the full dose radiation field.
  • Overall survival [ Time Frame: Up to 3 months post-treatment ] [ Designated as safety issue: No ]
    Failure: death due to any cause.
  • Grade 2 toxicity attributable to radiation treatment [ Time Frame: Up to 3 months post-treatment ] [ Designated as safety issue: Yes ]
    Toxicity will be graded based on CTCAE 4.0.

Eligibility Criteria

Inclusion Criteria:
  • Women of child-bearing age must have a negative pregnancy test
  • Patients must have received prior radiation treatment to the chest; records of prior radiation treatment must be available
  • Patients must have received prior chest radiation at least 3 months prior to enrollment in this trial; radiation treatment to other body sites not overlapping with current radiation fields are allowed within the 3 months period (example, brain radiation is allowed)
  • Patients must have a prior diagnosis of cancer inside the thoracic cavity; both primary thoracic malignancies (such as lung cancer) as well as metastatic lesions (such as metastatic breast cancer or colorectal cancer to the lungs) are allowed; patient must have pathologic confirmation of the recurrent thoracic tumor, or have an enlarging thoracic mass (as seen on two computed tomography [CT] scans at least 6 weeks apart, with either a > 25% or > 5 mm increase in longest dimension)
  • Patients must have a life expectancy of > 6 months
  • Patients must have measurable disease to be treated with proton radiation (minimum tumor dimension at least 10 mm on CT imaging)
  • Patients should have either non-metastatic cancer of the thorax, or metastatic cancer to the thorax and candidate for definitive radiation dose to the thoracic tumor (not palliative intent), tumor radiation dose to at least BED2Gy 60 Gy
  • Patients must be able to receive proton radiation treatment
  • All stages of cancer are eligible
  • There are no limits on prior therapy; patients are allowed to have prior chemotherapy and surgery; patients are allowed to have concurrent chemotherapy with radiation treatment; patients are allowed to have chemotherapy or surgery after radiation treatment
  • Patients are allowed to be on another study concurrent with this protocol
  • Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
  • Patients who have never received radiation to the chest
  • Patients who received radiation to the chest within the past 3 months (in a region that overlaps with current radiation fields)
  • Patients with life expectancy < 6 months
  • Pregnant women
  • Patients unable to provide informed consent
  • Prisoners
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