Active Surveillance in Early Lung Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 65 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03923777
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Vermont Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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.

Arms & Interventions

Arms

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Vermont Medical Center, Burlington, Vermont

Status

Address

University of Vermont Medical Center

Burlington, Vermont, 05401

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