Active Surveillance in Early Lung Cancer (ACTION-Lung)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03923777|
Recruitment Status : Enrolling by invitation
First Posted : April 23, 2019
Last Update Posted : July 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stage IA Non-small Cell Lung Cancer Lung Carcinoid Tumor||Other: Active Surveillance||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||Pilot Study Involving Active Surveillance With CT Imaging and Liquid BiOpsies iN Stage IA Lung Cancer (ACTION-Lung)|
|Actual Study Start Date :||July 31, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||July 2022|
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.
Other: Active Surveillance
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.
- Primary Objective: Freedom-from radiation rate for patients on active surveillance [ Time Frame: One year ]Freedom-from radiation rate for patients on active surveillance
- Secondary Objective: umber of participants on active surveillance with increased anxiety, depression, and uncertainty [ Time Frame: Two years ]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.
- Correlative Science Objective [ Time Frame: Two years ]To correlate circulating tumor DNA [ctDNA], circulating tumor cells [CTCs], a cancer-associated macrophage-like cells [CAMLs] with disease aggressiveness as measured by VDT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923777
|United States, Vermont|
|University of Vermont Medical Center|
|Burlington, Vermont, United States, 05401|