UnknownNot applicableNCT03923777
Official study title

Active Surveillance in Early Lung Cancer

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedActive Surveillance

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 16, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Unknown

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Vermont Medical Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
University of Vermont Medical Center
Interventions being studied
Other: Active Surveillance
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Main Cohort
  • 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 \[Not required pre-enrollment, and frequency as deemed appropriate by managing oncologist\].
Reasons someone may not be able to joinExclusion criteria
  • (both cohorts):
  • Prior radiation treatment of the study NSCLC.
  • Prior receipt of any systemic treatment for the study NSCLC.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Vermont Medical CenterBurlington, Vermont

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 16, 2020. Always confirm current availability with the study team.

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