Active Surveillance in Early Lung Cancer

NCT03923777 | Unknown

• 1 other identifier: Chrms 18-0396
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Active Surveillance

Outcome Measures

Primary Outcomes (1)

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

  Freedom-from radiation rate for patients on active surveillance

  One year

Secondary Outcomes (1)

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

  Two years

Other Outcomes (1)

• Correlative Science Objective

  Two years

Study Arms (1)

Active Surveillance

OTHER

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.

Other: Active Surveillance

Interventions

Active Surveillance OTHER

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.

Active Surveillance

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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. \[Preferably before biopsy performed\]
• 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.

You may not qualify if:

• Prior radiation treatment of the study NSCLC.
• Prior receipt of any systemic treatment for the study NSCLC.

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• 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.

  PMID: 30648024 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncology Physician

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 23, 2019
• Study Start: July 31, 2018
• Primary Completion: December 1, 2020
• Study Completion: July 1, 2022
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

US (1)