Non-Small Cell Lung CancerHUM15709NCT01190527
Using FDG-PET During Radiation Therapy in Non-Small Cell Lung Cancer
A study testing FDG-PET in people with Non-Small Cell Lung Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
Successful treatment of non-small cell lung cancer with radiation therapy requires that the physicians determine exactly where the tumor is in your body, and protect your normal tissue. 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?
- FDG-PET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to 6 Jan 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have FDG-avid and pathologically proven non-small cell lung cancer. If pathology not definitive, the patient needs to have a clinically diagnosed non-small cell lung cancer, which is also FDG-avid.
- Patients must be 18 years of age or older.
- Patients must have Karnofsky performance score > 60.
- Patients must have clinical AJCC (American Joint Committee on Cancer) Stage I-IIIB, with unresectable or inoperable disease.
- Patients must have no evidence of a malignant pleural or pericardial effusion
- Patients must have hemoglobin > 10 gm/dl. Transfusions or medications may be used to achieve this criterion.
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- Patients must have reasonable organ and marrow functions as defined below if chemotherapy is considered:
- WBC (White Blood Cell) > 3,000/mm3.
- absolute neutrophil count ≥ 1,500/mm3.
- platelets > 100,000/mm3
- total bilirubin ≤ 3.0 mg/dl.
- AST ( Aspartate Aminotransferase or SGOT) and ALT (Alanine Transaminase or SGPT) < 4 X institutional upper limit of normal.
- creatinine ≤ 2.0 mg/dl.
- Patients must not have serious intercurrent diseases per the judgment of the treating physician.
- Patient must be willing to use effective contraception if female with reproductive capability.
- Patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
Who cannot join
- Patients with any component of small cell lung carcinoma are excluded from this study.
- Prior radiotherapy to the thorax such that composite radiation would significantly overdose critical structures, either per estimation of the treating radiation oncologist or defined by failure to meet normal tissue tolerance constraints.
- Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects.
- Prisoners are excluded for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Using FDG-PET Acquired During the Course of Radiation Therapy to Individualize Adaptive Radiation Dose Escalation in Patients With Non-Small Cell Lung Cancer
Successful treatment of non-small cell lung cancer with radiation therapy requires that the physicians determine exactly where the tumor is in your body, and protect your normal tissue. This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) before treatment, and then again during treatment to see if the procedure helps predict how well the treatment works for your cancer and how well your lung functions during treatment. FDG-PET is a modern technology that uses small amounts of a radioactive glucose (FDG) to make images of your whole body and areas of active cancer. A Computerized Tomography (CT) will also be performed along with both of these procedures to help the researchers see clearly where your cancer or your healthy lung is located. The study will help the investigator determine whether an adaptive plan that is applied based on repeat PET-CT imaging during the course of radiation therapy (during RT), can show if there is an improvement in treatment outcome compared to those treated with standard radiation therapy. This adaptive plan may allow your doctor to escalate the dose per treatment and the total dose of your treatment based on the risk of damage to your healthy lung tissue. While increasing the radiation dose, but limiting the toxicity to normal lung tissue, the researchers hope to improve your tumor control.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- FDG-PET
- 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.
FDG-PETRadiation
This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) before treatment and again during treatment to see if it helps predict how well the treatment works for the cancer. The standard of care for patients with stage III unresectable NSCLC is combined chemoradiotherapy. This study will seek to determine 2 year local-regional progression free survival in patients with non-small cell lung cancer (NSCLC) when an adaptive plan is applied based on repeat PET-CT imaging during the course of radiation therapy (during RT), and investigate if there is an improvement compared to those treated with conventional radiation therapy without field and/or dose modification. The investigators hypothesize that during-RT, PET-CT-based adaptive therapy will allow them to dose escalate in the majority of patients and meet the dose limits of normal structures, thus improving local tumor control without increasing toxicity.
| Study group | Role | What they receive |
|---|---|---|
| FDG-PET | Other | All subjects will have the same course of treatment, the study treatment. Receives: Radiation: FDG-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT)
Use FGD-PET-CT based adaptive radiation to deliver a higher total dose to the active tumor to determine if it will improve the local-regional tumor control and progression-free survival in patients, without increasing the normal tissue complication probability (NTCP) of the lung.
Measured: 2 years
Secondary outcomes (3)
Number of Patients That Were Able to Receive Dose Escalation
The number of patients for which dose escalation was possible will be reported.
Measured: 2 Years
Percentage of Patients Alive at 2 Years
Overall survival of all patients will be estimated
Measured: 2 years
The Number of Participants That Experience Lung Toxicity and Esophagitis
The number of participants that experience RT (radiation therapy) induced lung toxicity, and grade 2 or greater (symptomatic) esophagitis, will be recorded.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startAug 2008
- Primary completionJul 2014
- Study completion6 Jan 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shruti Jolly, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190527
- Sponsor's protocol ID
- UMCC 2007.123
- Acronym
- HUM15709
- Status last verified
- May 2017
- First submitted
- 1 Apr 2010
- Last updated
- 2 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kong FM, Ten Haken RK, Schipper M, Frey KA, Hayman J, Gross M, Ramnath N, Hassan KA, Matuszak M, Ritter T, Bi N, Wang W, Orringer M, Cease KB, Lawrence TS, Kalemkerian GP. Effect of Midtreatment PET/CT-Adapted Radiation Therapy With Concurrent Chemotherapy in Patients With Locally Advanced Non-Small-Cell Lung Cancer: A Phase 2 Clinical Trial. JAMA Oncol. 2017 Oct 1;3(10):1358-1365. doi: 10.1001/jamaoncol.2017.0982.
PubMed 28570742
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using FDG-PET Acquired During the Course of Radiation Therapy to Individualize Adaptive Radiation Dose Escalation in Patients With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01190527
- Acronym / sponsor ID
- HUM15709 / UMCC 2007.123
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- 6 Jan 2015 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Posted 14 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Successful treatment of non-small cell lung cancer with radiation therapy requires that the physicians determine exactly where the tumor is in your body, and protect your normal tissue. This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) before treatment, and then again during treatment to see if the procedure helps predict how well the treatment works for your cancer and how well your lung functions during treatment. FDG-PET is a modern technology that uses small amounts of a radioactive glucose (FDG) to make images of your whole body and areas of active cancer. A Computerized Tomography (CT) will also be performed along with both of these procedures to help the researchers see clearly where your cancer or your healthy lung is located. The study will help the investigator determine whether an adaptive plan that is applied based on repeat PET-CT imaging during the course of radiation therapy (during RT), can show if there is an improvement in treatment outcome compared to those treated with standard radiation therapy. This adaptive plan may allow your doctor to escalate the dose per treatment and the total dose of your treatment based on the risk of damage to your healthy lung tissue. While increasing the radiation dose, but limiting the toxicity to normal lung tissue, the researchers hope to improve your tumor control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDG-PET | Other | Radiation: FDG-PETAll subjects will have the same course of treatment, the study treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have FDG-avid and pathologically proven non-small cell lung cancer. If pathology not definitive, the patient needs to have a clinically diagnosed non-small cell lung cancer, which is also FDG-avid.
- Patients must be 18 years of age or older.
- Patients must have Karnofsky performance score > 60.
- Patients must have clinical AJCC (American Joint Committee on Cancer) Stage I-IIIB, with unresectable or inoperable disease.
- Patients must have no evidence of a malignant pleural or pericardial effusion
Key exclusion criteria (4 listed)
- Patients with any component of small cell lung carcinoma are excluded from this study.
- Prior radiotherapy to the thorax such that composite radiation would significantly overdose critical structures, either per estimation of the treating radiation oncologist or defined by failure to meet normal tissue tolerance constraints.
- Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects.
- Prisoners are excluded for this study.
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 |
|---|---|---|
| FDG-PETThis study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) before treatment and again during treatment to see if it helps predict how well the treatment works for the cancer. The standard of care for patients with stage III unresectable NSCLC is combined chemoradiotherapy. This study will seek to determine 2 year local-regional progression free survival in patients with non-small cell lung cancer (NSCLC) when an adaptive plan is applied based on repeat PET-CT imaging during the course of radiation therapy (during RT), and investigate if there is an improvement compared to those treated with conventional radiation therapy without field and/or dose modification. The investigators hypothesize that during-RT, PET-CT-based adaptive therapy will allow them to dose escalate in the majority of patients and meet the dose limits of normal structures, thus improving local tumor control without increasing toxicity. | Radiation | FDG-PET |
Primary outcome
2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT)
Time frame: 2 years
Use FGD-PET-CT based adaptive radiation to deliver a higher total dose to the active tumor to determine if it will improve the local-regional tumor control and progression-free survival in patients, without increasing the normal tissue complication probability (NTCP) of the lung.
3 secondary outcomes
Number of Patients That Were Able to Receive Dose Escalation
Time frame: 2 Years
Percentage of Patients Alive at 2 Years
Time frame: 2 years
The Number of Participants That Experience Lung Toxicity and Esophagitis
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28570742Kong FM, Ten Haken RK, Schipper M, Frey KA, Hayman J, Gross M, Ramnath N, Hassan KA, Matuszak M, Ritter T, Bi N, Wang W, Orringer M, Cease KB, Lawrence TS, Kalemkerian GP. Effect of Midtreatment PET/CT-Adapted Radiation Therapy With Concurrent Chemotherapy in Patients With Locally Advanced Non-Small-Cell Lung Cancer: A Phase 2 Clinical Trial. JAMA Oncol. 2017 Oct 1;3(10):1358-1365. doi: 10.1001/jamaoncol.2017.0982.
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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.
Shruti Jolly, M.D. principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG-PET in people with Non-Small Cell Lung Cancer, run by University of Michigan Rogel 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 16 inclusion and 4 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 2 Jun 2017. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2015). 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?
2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01190527, which also lists 1 linked publication.
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 Jun 2017.