N/A
Completed N=6
Proton Beam Re-Irradiation in Thoracic Cancers
Metastatic Malignant Neoplasm in the Lung · Recurrent Disease · Thoracic Neoplasm
Source: ClinicalTrials.gov NCT02204761 ↗
Enrolled (actual)
6
Serious AEs
33.3%
Results posted
Nov 2018
Primary outcomePrimary: Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment — 2 Participants
Summary
This pilot clinical trial studies proton beam radiation therapy in treating patients with thoracic cancer that has come back and have received prior radiation therapy. Proton beam radiation therapy uses high energy protons to kill tumor cells and may cause less damage to normal tissue.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment |
2 | — |
| SECONDARY Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment |
2 | — |
| SECONDARY Number of Participants With Local Control of Cancer |
6 | — |
| SECONDARY Number of Participants Alive |
6 | — |
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
Data sourced from ClinicalTrials.gov (NCT02204761). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.