Active Surveillance in Early Lung Cancer

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Brief Title

Active Surveillance in Early Lung Cancer

Official Title

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

Interventional


Primary Outcome

Primary Objective: Freedom-from radiation rate for patients on active surveillance

Secondary Outcome

 Secondary Objective: umber of participants on active surveillance with increased anxiety, depression, and uncertainty

Condition

Stage IA Non-small Cell Lung Cancer

Intervention

Active Surveillance

Study Arms / Comparison Groups

 Active Surveillance
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

26

Start Date

July 31, 2018

Completion Date

July 2022

Primary Completion Date

December 2020

Eligibility 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.
      

Gender

All

Ages

65 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03923777

Organization ID

Chrms 18-0396


Responsible Party

Principal Investigator

Study Sponsor

University of Vermont Medical Center


Study Sponsor

, , 


Verification Date

July 2020