Non-small Cell Lung CancerPhase 1NCT01165658
Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies
A Phase 1 study testing Proton Therapy in people with Non-small Cell Lung Cancer and Small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to study the safety of giving larger daily doses of proton radiation therapy than the standard dose levels given to treat lung cancer. Researchers want to find the highest daily dose of proton radiation that can be given without having to stop therapy due to side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Small Cell Lung Cancer, Carcinoid
- What is being tested?
- Proton Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2010to 19 Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented NSCLC, SCLC, thymic tumors, or carcinoid tumors
- Patients not receiving concurrent chemotherapy
- Patients that are eligible for concurrent treatment with biologic agents (epidermal growth factor receptor [EGFR] or vascular endothelial growth factor [VEGF] inhibitors) will be eligible for the study.
Who cannot join
- Prior radiotherapy to the chest
- Life expectancy <6 months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies
The goal of this clinical research study is to study the safety of giving larger daily doses of proton radiation therapy than the standard dose levels given to treat lung cancer. Researchers want to find the highest daily dose of proton radiation that can be given without having to stop therapy due to side effects.
Read the detailed description
Proton Therapy:
Proton therapy is a type of radiation that is designed to lower the amount of radiation given to the healthy tissue around the tumor by using a more focused beam of radiation.
Radiation Dose Levels:
If you are found to be eligible to take part in this study, you will be assigned to receive 1 of 3 doses of radiation therapy, based on when you joined the study. The first group of at least 3 participants will receive the lowest total radiation dose. If the first dose is tolerated well by the first group of participants in this study, then the next group of participants will receive the second, higher dose of radiation. If this dose is tolerated, then a third group will be treated at the highest dose.
Practice Visit:
You will have a "practice" radiation visit to plan how the radiation will be given, about 1 week before therapy. This practice visit should take about 1-2 hours. At this visit, you will have a CT scan of the chest that will be used by the study staff to plan your proton therapy. A mold (made of the type of material used for casts) will also be made around your body that will be used to help you remain still during radiation therapy. Marks will be made on your skin to help position your body correctly for the radiation therapy. These marks may be permanent or temporary. If temporary marks are washed off, they will be replaced.
Proton Therapy Visits:
About 1 week after the practice radiation visit, you will begin receiving radiation therapy. At each visit, you will lie down in the mold of your body that was made at the practice visit, and you will be lined up for radiation therapy using the marks made on your skin at the practice visit.
You will receive radiation therapy every weekday (Monday-Friday) for about 3 weeks. Each radiation session should last about 45-60 minutes.
Study Tests:
Each week while you are receiving radiation therapy, you will be asked about any side effects you may be having. Your medical history will be recorded, and you will have a physical exam. If your doctor thinks it is needed, blood (about 2 tablespoons each time) will be drawn for routine tests, and/or you may have CT scans to check the status of the tumor.
Length of Therapy:
You will receive proton radiation therapy for about 3 weeks. The radiation therapy will be stopped early if the disease gets worse or intolerable side effects occur.
Follow-up Visits:
About 6 weeks after your last dose of proton radiation, you will have a CT scan of the chest (with a contrast agent, if possible) and a physical exam.
About 3 months after the first follow-up visit you will have a physical exam, lung function tests, and either a PET/CT scan or CT scan of the chest to check the status of the disease.
Long-term Follow-up:
Every 3 months for the first 2 years after you finish proton therapy, every 6 months for the next 3 years, and 1 time every year after that, you will be asked to return to the clinic for follow-up tests. These tests may include lung function tests, imaging scans (such as a CT or PET/CT scan), and/or an ECG. This will be up to your doctor.
This is an investigational study. At this time, it is considered investigational to give proton radiation therapy at the dose schedule used in this study. This schedule is being used for research purposes only.
Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Being tested
- Proton Therapy
- Keywords
- non-small cell lung cancer, NSCLC, small cell lung cancer, SCLC, carcinoid, thymic cancer, lung cancer, radiation therapy, radiotherapy, proton therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Carcinoid Tumor, Thymus Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton TherapyRadiation
Also called Radiation, XRT, Radiotherapy
The regimen of 45 Gy in 15 fractions will be delivered as a baseline, and then the fraction size will be escalated in two different intervals of 0.5 Gy each, with the ultimate dose being 60 Gy in 4 Gy fractions.
| Study group | Role | What they receive |
|---|---|---|
| Proton Therapy | Experimental | The radiation prescription dose ranges from 45 Gy in 3 Gy fractions to 60 Gy in 4 Gy fractions. Patients will be assigned to receive 1 of 3 doses of radiation therapy, based on when they joined the study. The first group of at least 3 participants will receive the lowest total radiation dose. If the first dose is tolerated well by the first group of participants in this study, then the next group of participants will receive the second, higher dose of radiation. If this dose is tolerated, then a third group will be treated at the highest dose. Receives: Radiation: Proton Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Hypofractionated Proton Therapy
Dose-limiting toxicity (DLT) defined as any CTCAE v4.0 grade 4 complication of esophagus or skin, or any grade 3 or higher complications of other organ systems (i.e. lung, liver, kidney, or GI tract), unless these complications are deemed to be related to those of esophagus. DLT assessed within 1 month of completion of radiation therapy. MTD defined as highest dose for which probability of toxicity is closest to 25%.
Measured: 1 month after completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study start16 Jul 2010
- Primary completion19 Jul 2016
- Study completion19 Jul 2016
Why it stopped: Requested by PI during yearly Continuing Review
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Gomez, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165658
- Sponsor's protocol ID
- 2010-0164
- Other IDs
- NCI-2012-01780
- Status last verified
- Dec 2019
- First submitted
- 16 Jul 2010
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies
- ClinicalTrials.gov ID
- NCT01165658
- Acronym / sponsor ID
- 2010-0164
- Keywords
- non-small cell lung cancer, NSCLC, small cell lung cancer, SCLC, carcinoid, thymic cancer, lung cancer, radiation therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Requested by PI during yearly Continuing Review
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 16 Jul 2010 (actual)
- Primary completion
- 19 Jul 2016 (actual)
- Study completion
- 19 Jul 2016 (actual)
- First posted
- 20 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to study the safety of giving larger daily doses of proton radiation therapy than the standard dose levels given to treat lung cancer. Researchers want to find the highest daily dose of proton radiation that can be given without having to stop therapy due to side effects.
Detailed description
Proton Therapy:
Proton therapy is a type of radiation that is designed to lower the amount of radiation given to the healthy tissue around the tumor by using a more focused beam of radiation.
Radiation Dose Levels:
If you are found to be eligible to take part in this study, you will be assigned to receive 1 of 3 doses of radiation therapy, based on when you joined the study. The first group of at least 3 participants will receive the lowest total radiation dose. If the first dose is tolerated well by the first group of participants in this study, then the next group of participants will receive the second, higher dose of radiation. If this dose is tolerated, then a third group will be treated at the highest dose.
Practice Visit:
You will have a "practice" radiation visit to plan how the radiation will be given, about 1 week before therapy. This practice visit should take about 1-2 hours. At this visit, you will have a CT scan of the chest that will be used by the study staff to plan your proton therapy. A mold (made of the type of material used for casts) will also be made around your body that will be used to help you remain still during radiation therapy. Marks will be made on your skin to help position your body correctly for the radiation therapy. These marks may be permanent or temporary. If temporary marks are washed off, they will be replaced.
Proton Therapy Visits:
About 1 week after the practice radiation visit, you will begin receiving radiation therapy. At each visit, you will lie down in the mold of your body that was made at the practice visit, and you will be lined up for radiation therapy using the marks made on your skin at the practice visit.
You will receive radiation therapy every weekday (Monday-Friday) for about 3 weeks. Each radiation session should last about 45-60 minutes.
Study Tests:
Each week while you are receiving radiation therapy, you will be asked about any side effects you may be having. Your medical history will be recorded, and you will have a physical exam. If your doctor thinks it is needed, blood (about 2 tablespoons each time) will be drawn for routine tests, and/or you may have CT scans to check the status of the tumor.
Length of Therapy:
You will receive proton radiation therapy for about 3 weeks. The radiation therapy will be stopped early if the disease gets worse or intolerable side effects occur.
Follow-up Visits:
About 6 weeks after your last dose of proton radiation, you will have a CT scan of the chest (with a contrast agent, if possible) and a physical exam.
About 3 months after the first follow-up visit you will have a physical exam, lung function tests, and either a PET/CT scan or CT scan of the chest to check the status of the disease.
Long-term Follow-up:
Every 3 months for the first 2 years after you finish proton therapy, every 6 months for the next 3 years, and 1 time every year after that, you will be asked to return to the clinic for follow-up tests. These tests may include lung function tests, imaging scans (such as a CT or PET/CT scan), and/or an ECG. This will be up to your doctor.
This is an investigational study. At this time, it is considered investigational to give proton radiation therapy at the dose schedule used in this study. This schedule is being used for research purposes only.
Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Therapy | Experimental | Radiation: Proton TherapyThe radiation prescription dose ranges from 45 Gy in 3 Gy fractions to 60 Gy in 4 Gy fractions. Patients will be assigned to receive 1 of 3 doses of radiation therapy, based on when they joined the study. The first group of at least 3 participants will receive the lowest total radiation dose. If the first dose is tolerated well by the first group of participants in this study, then the next group of participants will receive the second, higher dose of radiation. If this dose is tolerated, then a third group will be treated at the highest dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically documented NSCLC, SCLC, thymic tumors, or carcinoid tumors
- Patients not receiving concurrent chemotherapy
- Patients that are eligible for concurrent treatment with biologic agents (epidermal growth factor receptor [EGFR] or vascular endothelial growth factor [VEGF] inhibitors) will be eligible for the study.
Key exclusion criteria (3 listed)
- Prior radiotherapy to the chest
- Life expectancy <6 months
- Pregnancy
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 TherapyAlso: Radiation, XRT, RadiotherapyThe regimen of 45 Gy in 15 fractions will be delivered as a baseline, and then the fraction size will be escalated in two different intervals of 0.5 Gy each, with the ultimate dose being 60 Gy in 4 Gy fractions. | Radiation | Proton Therapy |
Primary outcome
Maximum Tolerated Dose (MTD) of Hypofractionated Proton Therapy
Time frame: 1 month after completion of radiation therapy
Dose-limiting toxicity (DLT) defined as any CTCAE v4.0 grade 4 complication of esophagus or skin, or any grade 3 or higher complications of other organ systems (i.e. lung, liver, kidney, or GI tract), unless these complications are deemed to be related to those of esophagus. DLT assessed within 1 month of completion of radiation therapy. MTD defined as highest dose for which probability of toxicity is closest to 25%.
Results and safety
The study was stopped early (reason given: Requested by PI during yearly Continuing Review). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Daniel Gomez, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Proton Therapy in people with Non-small Cell Lung Cancer and Small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 1 site 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Requested by PI during yearly Continuing Review). Results are not available in the source record.
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?
Maximum Tolerated Dose (MTD) of Hypofractionated Proton Therapy (time frame: 1 month after completion of radiation therapy). 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 2 Jan 2020.