Non-Small Cell Lung CancerNCT01808677
Registry Study of Thoracic Reirradiation for Non-Small Cell Lung Cancer (NSCLC) Utilizing Proton Beam Therapy or Intensity Modulated Radiation Therapy
An observational study of Non-Small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn more about the safety of treating NSCLC with reirradiation using standard methods and to look for ways to lessen side effects and improve therapy. Reirradiation is when radiation is given to an area of the body that has previously received a full dose of radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Thoracic Reirradiation Registry
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Aug 2016
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: Patients being treated with thoracic reirradiation with PBT or IMRT for NSCLC, with or without chemotherapy at UT MD Anderson Cancer Center in Houston, Texas.
Who may be able to join
- History of previous histologically or cytologically documented NSCLC, stage I-IV.
- Prior course of radiation therapy or concurrent chemoradiation at least 1 month prior to the current course of radiation therapy.
- Patients eligible to receive a second course of radiation therapy to the thorax, at the discretion of the treating physician.
- Patients receiving concurrent chemotherapy or targeted agents will be eligible for this protocol.
- 3.2 Exclusion Criteria:
- Life expectancy<3 months
- Pregnancy.
Who cannot join
None listed.
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
The goal of this research study is to learn more about the safety of treating NSCLC with reirradiation using standard methods and to look for ways to lessen side effects and improve therapy. Reirradiation is when radiation is given to an area of the body that has previously received a full dose of radiation.
Read the detailed description
If you agree to take part in this study, data will be recorded during your therapy. The data to be recorded will include your medical history, the disease, treatments you have received and how you have responded to any treatments, as well as any side effects you may have had.
The data will be stored on a password-protected computer at MD Anderson for use in future research related to cancer.
Your data will be given a code number. No identifying information will be directly linked to your data. Only the researcher in charge of this study will have access to the code numbers and be able to link the data to you. This is to allow medical information related to your data to be updated as needed. Other researchers using your data will not be able to link this data to you.
Length of Study:
After you sign this consent form, your active participation on this study will be over.
This is an investigational study.
Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Thoracic Reirradiation Registry
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Thoracic reirradiation, Proton beam therapy, PBT, Intensity modulated radiation therapy, IMRT, Registry, Data
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Reirradiation RegistryOther
Data collected in the registry includes patient characteristics/demographics, disease characteristics, treatment details (radiation, chemotherapy, surgery, etc.), toxicity rates, and survival outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Reirradiation Registry | Data collection on patients being treated with thoracic reirradiation with PBT or IMRT for NSCLC, with or without chemotherapy. Receives: Other: Thoracic Reirradiation Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of High-Grade Toxicity
Primary objective to assess the prevalence of high-grade toxicity in patients being treated with thoracic reirradiation with proton beam therapy (PBT) or intensity modulated radiation therapy (IMRT) for non-small cell lung cancer (NSCLC), with or without chemotherapy. High-grade toxicity defined as CTCAE v4.0 Grade 3 or higher toxicity, or CTCAE v4.0 grade 4 or higher toxicity of the esophagus. Data collected from 1/2/2012 to 1/31/2017. High-grade toxicity rate and its corresponding 95% confidence interval provided at end of study. Logistic regression model used to assess the association between prognostic factors such as total dose to normal tissue structures, time since initial course of RT, failure in same lobe of the lung, failure in nodal regions, and central vs. peripheral location and high-grade toxicity.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startJun 2012
- Primary completionAug 2016
- Study completionAug 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
- Target duration
- 5 Years
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
- NCT01808677
- Sponsor's protocol ID
- PA11-1193
- Status last verified
- Aug 2016
- First submitted
- 7 Mar 2013
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study of Thoracic Reirradiation for Non-Small Cell Lung Cancer (NSCLC) Utilizing Proton Beam Therapy or Intensity Modulated Radiation Therapy
- ClinicalTrials.gov ID
- NCT01808677
- Acronym / sponsor ID
- PA11-1193
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Thoracic reirradiation, Proton beam therapy, PBT, Intensity modulated radiation therapy, IMRT, Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Mar 2013 (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 research study is to learn more about the safety of treating NSCLC with reirradiation using standard methods and to look for ways to lessen side effects and improve therapy. Reirradiation is when radiation is given to an area of the body that has previously received a full dose of radiation.
Detailed description
If you agree to take part in this study, data will be recorded during your therapy. The data to be recorded will include your medical history, the disease, treatments you have received and how you have responded to any treatments, as well as any side effects you may have had.
The data will be stored on a password-protected computer at MD Anderson for use in future research related to cancer.
Your data will be given a code number. No identifying information will be directly linked to your data. Only the researcher in charge of this study will have access to the code numbers and be able to link the data to you. This is to allow medical information related to your data to be updated as needed. Other researchers using your data will not be able to link this data to you.
Length of Study:
After you sign this consent form, your active participation on this study will be over.
This is an investigational study.
Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic Reirradiation Registry | – | Other: Thoracic Reirradiation RegistryData collection on patients being treated with thoracic reirradiation with PBT or IMRT for NSCLC, with or without chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being treated with thoracic reirradiation with PBT or IMRT for NSCLC, with or without chemotherapy at UT MD Anderson Cancer Center in Houston, Texas.
Key inclusion criteria (7 listed)
- History of previous histologically or cytologically documented NSCLC, stage I-IV.
- Prior course of radiation therapy or concurrent chemoradiation at least 1 month prior to the current course of radiation therapy.
- Patients eligible to receive a second course of radiation therapy to the thorax, at the discretion of the treating physician.
- Patients receiving concurrent chemotherapy or targeted agents will be eligible for this protocol.
- Life expectancy<3 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Thoracic Reirradiation RegistryData collected in the registry includes patient characteristics/demographics, disease characteristics, treatment details (radiation, chemotherapy, surgery, etc.), toxicity rates, and survival outcomes. | Other | Thoracic Reirradiation Registry |
Primary outcome
Prevalence of High-Grade Toxicity
Time frame: 5 years
Primary objective to assess the prevalence of high-grade toxicity in patients being treated with thoracic reirradiation with proton beam therapy (PBT) or intensity modulated radiation therapy (IMRT) for non-small cell lung cancer (NSCLC), with or without chemotherapy. High-grade toxicity defined as CTCAE v4.0 Grade 3 or higher toxicity, or CTCAE v4.0 grade 4 or higher toxicity of the esophagus. Data collected from 1/2/2012 to 1/31/2017. High-grade toxicity rate and its corresponding 95% confidence interval provided at end of study. Logistic regression model used to assess the association between prognostic factors such as total dose to normal tissue structures, time since initial course of RT, failure in same lobe of the lung, failure in nodal regions, and central vs. peripheral location and high-grade toxicity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- 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?
An observational study of Non-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 7 inclusion and 0 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 24 Aug 2016. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of High-Grade Toxicity (time frame: 5 years). 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 24 Aug 2016.