Clinical trial NCT02204761: Proton Beam Re-Irradiation in Thoracic Cancers
Official title: Definitive Re-irradiation With Proton Beam Radiotherapy for Patients With Recurrent Thoracic Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Malignant Neoplasm in the Lung
Recurrent Disease
Thoracic Neoplasm
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-07-30
Enrollment: 6
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment
timeFrame: Up to 3 months post-treatment
Secondary outcomes:
measure: Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment
timeFrame: Up to 3 months post-treatment
measure: Number of Participants With Local Control of Cancer
timeFrame: Up to 3 months post-treatment
measure: Number of Participants Alive
timeFrame: Up to 3 months post-treatment
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
state: Washington
city: Seattle
country: United States
facility: ProCure Proton Therapy Center-Seattle
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
name: Jing Zeng
role: PRINCIPAL_INVESTIGATOR
References: