Metastatic Malignant Neoplasm in the Lung, Recurrent Disease, Thoracic Neoplasm
Conditions
Brief 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.
Detailed description
PRIMARY OBJECTIVES: I. To assess the grade 3 toxicity associated with thoracic re-irradiation with proton therapy, with prospectively applied normal organ radiation dose limits. SECONDARY OBJECTIVES: I. To assess the efficacy of thoracic re-irradiation with proton therapy. OUTLINE: Patients undergo proton beam radiation therapy per standard of care. After completion of study treatment, patients are followed up at 3 months.
Interventions
RADIATIONProton Beam Radiation Therapy
Undergo proton beam re-irradiation therapy
Sponsors
National Cancer Institute (NCI)
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment | Up to 3 months post-treatment | Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 generally means hospitalization required for management of side effects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment | Up to 3 months post-treatment | Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Grade 2 generally means medical therapy required to intervene due to toxicity. |
| Number of Participants With Local Control of Cancer | Up to 3 months post-treatment | Number of participants who did not have local failure as defined by: 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. |
| Number of Participants Alive | Up to 3 months post-treatment | Number of participants alive. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Proton Beam Radiation Therapy) Patients undergo proton beam radiation therapy per standard of care.
Proton Beam Radiation Therapy: Undergo proton beam radiation therapy | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Treatment (Proton Beam Radiation Therapy) |
|---|---|
| Age, Continuous | 71.7 years STANDARD_DEVIATION 8.8 |
| Number of participants with Grade 3+ toxicity from radiation | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 2 / 6 |
Outcome results
Primary
Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment
Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 generally means hospitalization required for management of side effects.
Time frame: Up to 3 months post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Proton Beam Radiation Therapy) | Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment | 2 Participants |
Secondary
Number of Participants Alive
Number of participants alive.
Time frame: Up to 3 months post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Proton Beam Radiation Therapy) | Number of Participants Alive | 6 Participants |
Secondary
Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment
Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Grade 2 generally means medical therapy required to intervene due to toxicity.
Time frame: Up to 3 months post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Proton Beam Radiation Therapy) | Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment | 2 Participants |
Secondary
Number of Participants With Local Control of Cancer
Number of participants who did not have local failure as defined by: 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.
Time frame: Up to 3 months post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Proton Beam Radiation Therapy) | Number of Participants With Local Control of Cancer | 6 Participants |