Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Christopher Anker, University of Vermont Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Stage IA Non-small Cell Lung Cancer Lung Carcinoid Tumor Other: Active Surveillance Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Active Surveillance
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 Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Cohort Inclusion Criteria:

  • Patient at UVMCC.
  • Has pathologically proven recent diagnosis (≤180 days) of solitary or multifocal Stage T1a/b/c, N0, M0 [AJCC Staging, 8th Ed.] non-small cell lung cancer [NSCLC] or carcinoid tumors.
  • History & physical ≤90 days prior to enrollment.
  • Tumors may have a solid component of any magnitude ≤3 cm.
  • Age ≥65 years old.
  • Charlson Comorbidity Index [CCI] ≥6 within 90 days prior to enrollment.
  • Zubrod performance status of 0-3 within 90 days prior to enrollment.
  • Deemed unresectable or "medically inoperable" due to medical co-morbidities. Otherwise operable patients who decline surgery are considered inoperable.
  • Eligible to receive treatment via SABR at the discretion of the treating oncologist.
  • CT scan of the chest (contrast preferred) ≤90 days of enrollment with slice thickness ≤3 mm.
  • Whole body PET scan ≤90 days prior to enrollment. [Preferably before biopsy performed]

Correlative Science Only Cohort Inclusion Criteria:

  • Patient at UVMCC.
  • Patients who have been followed via active surveillance > 180 days already may enroll in the correlative science only cohort for the purpose of blood draws only, regardless of reason active surveillance was chosen.
  • Pathologically proven diagnosis (>180 days prior to enrollment) of solitary or multifocal Stage T1a/b/c, N0, M0 [AJCC Staging, 8th Ed.] non-small cell lung cancer [NSCLC] or carcinoid tumors.
  • History & physical ≤90 days prior to enrollment.
  • Any age.
  • Any Charlson Comorbidity Index [CCI].
  • Zubrod performance status of 0-3 within 90 days prior to enrollment.
  • Can be medically operable or inoperable with any medical co-morbidities.
  • CT scan of the chest (contrast preferred) ≤90 days around (before or after) enrollment with slice thickness ≤3 mm. [Frequency as deemed appropriate by managing oncologist].
  • Whole body PET/CT scan [Not required pre-enrollment, and frequency as deemed appropriate by managing oncologist].

Exclusion Criteria (both cohorts):

  • Prior radiation treatment of the study NSCLC.
  • Prior receipt of any systemic treatment for the study NSCLC.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Vermont
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont Medical Center
Publications:
Layout table for additonal information
Responsible Party: Christopher Anker, Radiation Oncology Physician, University of Vermont Medical Center
ClinicalTrials.gov Identifier: NCT03923777    
Other Study ID Numbers: Chrms 18-0396
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher Anker, University of Vermont Medical Center:
Active Surveillance
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoid Tumor
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue