Clinical trial · Interventional
Active Surveillance in Early Lung Cancer
Pilot Study Involving Active Surveillance With CT Imaging and Liquid BiOpsies iN Stage IA Lung Cancer (ACTION-Lung)
NCT03923777CI-TRIAL-00045991ACTION-LungunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Carcinoid Tumor | Lung Neuroendocrine Tumor | ALIAS | 0.90 |
| Stage IA Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Surveillance | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 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.
- interventionNames
- Other: Active Surveillance
Primary outcomes (1)
- measure
- Primary Objective: Freedom-from radiation rate for patients on active surveillance
- timeFrame
- One year
- description
- Freedom-from radiation rate for patients on active surveillance
Secondary outcomes (1)
- measure
- Secondary Objective: umber of participants on active surveillance with increased anxiety, depression, and uncertainty
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDNo 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. PMID 30648024