Metastatic Malignant Neoplasm in the LungNCT02204761
Proton Beam Re-Irradiation in Thoracic Cancers
A study testing Proton Beam Radiation Therapy in people with Metastatic Malignant Neoplasm in the Lung and Recurrent Disease, run by University of Washington at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm in the Lung, Recurrent Disease, Thoracic Neoplasm
- What is being tested?
- Proton Beam Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Sep 2014to 7 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
ProCure Proton Therapy Center-Seattle
Seattle, Washington, 98133
About this study
Official title: Definitive Re-irradiation With Proton Beam Radiotherapy for Patients With Recurrent Thoracic Cancers
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the grade 3 toxicity associated with thoracic re-irradiation with proton therapy, with prospectively applied normal organ radiation dose limits.
SECONDARY OBJECTIVES:
- 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.
- Being tested
- Proton Beam Radiation Therapy
- Medical subject headings
- Recurrence, Thoracic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Beam Radiation TherapyRadiation
Undergo proton beam re-irradiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Proton beam radiation therapy Receives: Radiation: Proton Beam Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months post-treatment
Secondary outcomes (3)
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.
Measured: Up to 3 months post-treatment
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.
Measured: Up to 3 months post-treatment
Number of Participants Alive
Number of participants alive.
Measured: Up to 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study start9 Sep 2014
- Primary completion7 Sep 2017
- Study completion7 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Malignant Neoplasm in the LungStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jing Zeng, University of Washington
- Investigators
- Jing Zeng, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204761
- Sponsor's protocol ID
- 9148
- Other IDs
- NCI-2014-01468, 9148, P30CA015704
- Status last verified
- Nov 2018
- First submitted
- 28 Jul 2014
- Last updated
- 20 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definitive Re-irradiation With Proton Beam Radiotherapy for Patients With Recurrent Thoracic Cancers
- ClinicalTrials.gov ID
- NCT02204761
- Acronym / sponsor ID
- 9148
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Sep 2014 (actual)
- Primary completion
- 7 Sep 2017 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Posted 20 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the grade 3 toxicity associated with thoracic re-irradiation with proton therapy, with prospectively applied normal organ radiation dose limits.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: Proton Beam Radiation TherapyProton beam radiation therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton Beam Radiation TherapyUndergo proton beam re-irradiation therapy | Radiation | Treatment |
Primary outcome
Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment
Time frame: 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.
3 secondary outcomes
Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment
Time frame: Up to 3 months post-treatment
Number of Participants With Local Control of Cancer
Time frame: Up to 3 months post-treatment
Number of Participants Alive
Time frame: Up to 3 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Zeng principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton Beam Radiation Therapy in people with Metastatic Malignant Neoplasm in the Lung and Recurrent Disease, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment (time frame: Up to 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.