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出境医 / 临床实验 / Active Surveillance in Early Lung Cancer (ACTION-Lung)

Active Surveillance in Early Lung Cancer (ACTION-Lung)

Study Description
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.

Study Design
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
Arms and Interventions
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.

Outcome Measures
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.


Eligibility Criteria
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.
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE April 3, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date July 16, 2020
Actual Study Start Date  ICMJE July 31, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
Primary Objective: Freedom-from radiation rate for patients on active surveillance [ Time Frame: One year ]
Freedom-from radiation rate for patients on active surveillance
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 22, 2019)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Active Surveillance in Early Lung Cancer
Official Title  ICMJE Pilot Study Involving Active Surveillance With CT Imaging and Liquid BiOpsies iN Stage IA Lung Cancer (ACTION-Lung)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Stage IA Non-small Cell Lung Cancer
  • Lung Carcinoid Tumor
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Other: Active Surveillance
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 22, 2019)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03923777
Other Study ID Numbers  ICMJE Chrms 18-0396
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christopher Anker, University of Vermont Medical Center
Study Sponsor  ICMJE University of Vermont Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Vermont Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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