Stage IA Non-small Cell Lung CancerACTION-LungNCT03923777
Active Surveillance in Early Lung Cancer
A study testing Active Surveillance in people with Stage IA Non-small Cell Lung Cancer and Lung Carcinoid Tumor, run by University of Vermont Medical Center at 1 site in United States.
Trial summary
Cancer patients are often given the choice of delaying or avoiding treatment as one of their options. However, there is not much information guiding lung cancer patients and their clinicians regarding this approach. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Stage IA Non-small Cell Lung Cancer, Lung Carcinoid Tumor
- What is being tested?
- Active Surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2018to Jul 2022
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
None listed.
Who cannot join
- Prior radiation treatment of the study NSCLC.
- Prior receipt of any systemic treatment for the study NSCLC.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
Official title: Pilot Study Involving Active Surveillance With CT Imaging and Liquid BiOpsies iN Stage IA Lung Cancer (ACTION-Lung)
Cancer patients are often given the choice of delaying or avoiding treatment as one of their options. However, there is not much information guiding lung cancer patients and their clinicians regarding this approach. Active surveillance is a way of either delaying or avoiding treatment and its possible side effects through carefully watching for changes in the tumor and considering treatment if there is progression. The purpose of this research study is to evaluate active surveillance and ways to better understand if and when to treat patients with stage IA lung cancer.
Read the detailed description
The University of Vermont Medical Center is looking at determining if active surveillance is a viable option for low risk lung cancer patients. Currently, the National Cancer Care Network (NCCN) guidelines recommends considering stereotactic ablative radiotherapy (SABR) for patients not well enough for surgery, which is generally well tolerated, but it's also been shown to cause significant worsening of shortness of breath, fatigue, chest pain, and in extreme cases, death. Investigators are using this pilot study as a means to determine outcomes for patients who choose an active surveillance approach. This information could change future conversations between doctor and patient regarding treatment options, giving patients the choice to choose radiation therapy or to delay treatment by taking an active surveillance approach.
Investigators have published outcomes for 12 elderly patients with stage IA lung cancer who had chosen the active surveillance approach, reserving radiation therapy for when rapid tumor growth was determined (PMID 30648024). The clinical outcomes were similar to those expected if treatment had been provided, and at two years from the time the tumor was found almost half the patients were able to avoid getting radiation.
By deciding to participate in this study, patients are agreeing to postpone their treatment for an active surveillance approach while continuing with a computed tomography (CT) scan regimen to follow tumor growth. Once their tumor size is determined there are parameters in place to decide when patients should consider radiation. These parameters are based on speed of tumor growth over time and tumor size.
- Being tested
- Active Surveillance
- Keywords
- Active Surveillance
- 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.
Active SurveillanceOther
Agreeing to postpone treatment while continuing with a CT scan surveillance regimen to follow tumor growth. SABR should be offered if either the tumor is >3 cm in size or the VDT decreases to <400 days.
| Study group | Role | What they receive |
|---|---|---|
| Active Surveillance | Other | Active surveillance is a way of either delaying or avoiding treatment and its possible side effects through carefully watching for changes in the tumor. Patients continue on this regimen, watching for tumor growth, up to 2 years on study or until rate or extent of growth leads to a shared decision to initiate treatment, whichever comes first. Receives: Other: Active Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective: Freedom-from radiation rate for patients on active surveillance
Freedom-from radiation rate for patients on active surveillance
Measured: One year
Secondary outcomes (1)
Secondary Objective: umber of participants on active surveillance with increased anxiety, depression, and uncertainty
Number of participants on active surveillance with increased anxiety, depression, and uncertainty as assessed by the FACT-L, PROMIS-Fatigue, EQ-5D-5L, and State-Trait Anxiety Inventory questionnaires, change from baseline to end of study.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start31 Jul 2018
- Primary completionDec 2020 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IA 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
- Model description
- Investigators propose a study involving active surveillance for NSCLC where patients would have consideration of SABR if either the tumor exceeded 3 cm in size or the volume doubling time (VDT) decreased to \<400 days. Following enrollment, chest CT with contrast (with slice thickness ≤3 mm) to be performed 3 months (+/- 30 days) after the initial CT\]. Patients with VDTs \<400 days must be considered for SABR. SABR is not mandatory \[patient choice\] and active surveillance may be continued. Patients with VDTs ≥400 days continue active surveillance via serial CTs with intervals of every 3 months (+/- 30 days) up to 2 years total. Following informed consent, blood samples will be acquired following the protocol schedule based on enrollment group. Quality of life questionnaires will also be completed following the protocol schedule for the main cohort only.
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Anker, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923777
- Sponsor's protocol ID
- Chrms 18-0396
- Acronym
- ACTION-Lung
- Status last verified
- Jul 2020
- First submitted
- 3 Apr 2019
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
No HJ, Lester-Coll NH, Seward DJ, Sidiropoulos N, Gagne HM, Nelson CJ, Garrison GW, Kinsey CM, Lin SH, Anker CJ. Active Surveillance for Medically Inoperable Stage IA Lung Cancer in the Elderly. Cureus. 2018 Oct 22;10(10):e3472. doi: 10.7759/cureus.3472.
PubMed 30648024
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Involving Active Surveillance With CT Imaging and Liquid BiOpsies iN Stage IA Lung Cancer (ACTION-Lung)
- ClinicalTrials.gov ID
- NCT03923777
- Acronym / sponsor ID
- ACTION-Lung / Chrms 18-0396
- Keywords
- Active Surveillance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 23 Apr 2019 (actual)
- 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.
Cancer patients are often given the choice of delaying or avoiding treatment as one of their options. However, there is not much information guiding lung cancer patients and their clinicians regarding this approach. Active surveillance is a way of either delaying or avoiding treatment and its possible side effects through carefully watching for changes in the tumor and considering treatment if there is progression. The purpose of this research study is to evaluate active surveillance and ways to better understand if and when to treat patients with stage IA lung cancer.
Detailed description
The University of Vermont Medical Center is looking at determining if active surveillance is a viable option for low risk lung cancer patients. Currently, the National Cancer Care Network (NCCN) guidelines recommends considering stereotactic ablative radiotherapy (SABR) for patients not well enough for surgery, which is generally well tolerated, but it's also been shown to cause significant worsening of shortness of breath, fatigue, chest pain, and in extreme cases, death. Investigators are using this pilot study as a means to determine outcomes for patients who choose an active surveillance approach. This information could change future conversations between doctor and patient regarding treatment options, giving patients the choice to choose radiation therapy or to delay treatment by taking an active surveillance approach.
Investigators have published outcomes for 12 elderly patients with stage IA lung cancer who had chosen the active surveillance approach, reserving radiation therapy for when rapid tumor growth was determined (PMID 30648024). The clinical outcomes were similar to those expected if treatment had been provided, and at two years from the time the tumor was found almost half the patients were able to avoid getting radiation.
By deciding to participate in this study, patients are agreeing to postpone their treatment for an active surveillance approach while continuing with a computed tomography (CT) scan regimen to follow tumor growth. Once their tumor size is determined there are parameters in place to decide when patients should consider radiation. These parameters are based on speed of tumor growth over time and tumor size.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Investigators propose a study involving active surveillance for NSCLC where patients would have consideration of SABR if either the tumor exceeded 3 cm in size or the volume doubling time (VDT) decreased to <400 days. Following enrollment, chest CT with contrast (with slice thickness ≤3 mm) to be performed 3 months (+/- 30 days) after the initial CT]. Patients with VDTs <400 days must be considered for SABR. SABR is not mandatory [patient choice] and active surveillance may be continued. Patients with VDTs ≥400 days continue active surveillance via serial CTs with intervals of every 3 months (+/- 30 days) up to 2 years total. Following informed consent, blood samples will be acquired following the protocol schedule based on enrollment group. Quality of life questionnaires will also be completed following the protocol schedule for the main cohort only.
| Arm | Type | Receives |
|---|---|---|
| Active Surveillance | Other | Other: Active SurveillanceActive surveillance is a way of either delaying or avoiding treatment and its possible side effects through carefully watching for changes in the tumor. Patients continue on this regimen, watching for tumor growth, up to 2 years on study or until rate or extent of growth leads to a shared decision to initiate treatment, whichever comes first. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Prior radiation treatment of the study NSCLC.
- Prior receipt of any systemic treatment for the study NSCLC.
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 |
|---|---|---|
| Active SurveillanceAgreeing to postpone treatment while continuing with a CT scan surveillance regimen to follow tumor growth. SABR should be offered if either the tumor is >3 cm in size or the VDT decreases to <400 days. | Other | Active Surveillance |
Primary outcome
Primary Objective: Freedom-from radiation rate for patients on active surveillance
Time frame: One year
Freedom-from radiation rate for patients on active surveillance
1 secondary outcome
Secondary Objective: umber of participants on active surveillance with increased anxiety, depression, and uncertainty
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Background: PubMed 30648024No HJ, Lester-Coll NH, Seward DJ, Sidiropoulos N, Gagne HM, Nelson CJ, Garrison GW, Kinsey CM, Lin SH, Anker CJ. Active Surveillance for Medically Inoperable Stage IA Lung Cancer in the Elderly. Cureus. 2018 Oct 22;10(10):e3472. doi: 10.7759/cureus.3472.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Surveillance in people with Stage IA Non-small Cell Lung Cancer and Lung Carcinoid Tumor, run by University of Vermont Medical 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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Jul 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.
Are results available for this study?
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?
Primary Objective: Freedom-from radiation rate for patients on active surveillance (time frame: One year). 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 NCT03923777, 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 16 Jul 2020.