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Active Surveillance in Early Lung Cancer (ACTION-Lung)

Primary Purpose

Stage IA Non-small Cell Lung Cancer, Lung Carcinoid Tumor

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active Surveillance

About this trial

This is an interventional treatment trial for Stage IA Non-small Cell Lung Cancer focused on measuring Active Surveillance

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Vermont Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Active Surveillance

Arm 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.

Outcomes

Primary Outcome Measures

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

Freedom-from radiation rate for patients on active surveillance

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03923777

First Posted

April 3, 2019

Last Updated

July 14, 2020

Sponsor

University of Vermont Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03923777

Brief Title

Active Surveillance in Early Lung Cancer

Acronym

ACTION-Lung

Official Title

Pilot Study Involving Active Surveillance With CT Imaging and Liquid BiOpsies iN Stage IA Lung Cancer (ACTION-Lung)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 31, 2018 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Vermont Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage IA Non-small Cell Lung Cancer, Lung Carcinoid Tumor

Keywords

Active Surveillance

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active Surveillance

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Active Surveillance

Intervention Description

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 Measure Information:

Title

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

Description

Freedom-from radiation rate for patients on active surveillance

Time Frame

One year

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Two years

Other Pre-specified Outcome Measures:

Title

Correlative Science Objective

Description

To correlate circulating tumor DNA [ctDNA], circulating tumor cells [CTCs], a cancer-associated macrophage-like cells [CAMLs] with disease aggressiveness as measured by VDT.

Time Frame

Two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

University of Vermont Medical Center

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30648024

Citation

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.

Results Reference

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