Active Surveillance in Early Lung Cancer (ACTION-Lung)

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.

Study Overview

• Status: Unknown
• Conditions: Lung Carcinoid Tumor; Stage IA Non-small Cell Lung Cancer
• Intervention / Treatment: Other: Active Surveillance

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
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective: Freedom-from radiation rate for patients on active surveillance	Freedom-from radiation rate for patients on active surveillance	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Two years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlative Science Objective	To correlate circulating tumor DNA [ctDNA], circulating tumor cells [CTCs], a cancer-associated macrophage-like cells [CAMLs] with disease aggressiveness as measured by VDT.	Two years

Collaborators and Investigators

• Sponsor: University of Vermont Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (Actual): April 23, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Active Surveillance
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Lung Neoplasms; Carcinoid Tumor
• Other Study ID Numbers: Chrms 18-0396

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No