Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03923777
Study type Interventional
Source University of Vermont Medical Center
Contact
Status Enrolling by invitation
Phase N/A
Start date July 31, 2018
Completion date July 2022

See also
  Status Clinical Trial Phase
Recruiting NCT02288026 - Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer N/A
Withdrawn NCT02250378 - Stereotactic Radiosurgery Followed by Wedge Resection in Treating Patients With Early Stage Peripheral Non-small Cell Lung Cancer N/A
Terminated NCT01707823 - Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer Early Phase 1
Not yet recruiting NCT01595074 - Biomarkers in Predicting Treatment Response in Samples From Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy N/A
Active, not recruiting NCT03433469 - Osimertinib in Treating Participants With Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer Before Surgery Phase 2
Completed NCT01726296 - Adherence to Survivorship Care Guidelines in Health Care Providers for Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care N/A
Completed NCT01741636 - Survivorship Care Planning in Patients With Colorectal or Non-Small Cell Lung Cancer N/A
Completed NCT01457469 - Enhanced Quitline Intervention in Smoking Cessation for Patients With Non-Metastatic Lung Cancer Phase 1
Active, not recruiting NCT03066297 - Optimal Extent of Pulmonary Resection in Clinical Stage IA Non-Small Cell Lung Cancer
Completed NCT01999881 - Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients N/A
Terminated NCT00087269 - Erlotinib in Treating Patients With Stage I-IIIA Non-Small Cell Lung Cancer Undergoing Surgical Resection Phase 2
Completed NCT01840150 - Study to Evaluate NA-NOSE for Monitoring and Detecting Recurrence in Early Stage Lung Cancer N/A