Does Intense Regimented Surveillance Improve the Rates of Therapeutic Re-Intervention After Lung Cancer Surgery

NCT02149576 | Completed Phase 2 DMC

• 1 other identifier: SJHH_IntenseCT_Pilot
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 1

Brief Summary

After curative lung cancer surgery, there is a risk of recurrence of the primary cancer, or development of a new cancer. Historically, patients who have undergone curative lung cancer surgery have been monitored with chest radiographs (CXR). Unfortunately, 70% of such patients still die of lung cancer. As a result, there has been interest in other methods of surveillance in order to detect recurring or new cancers earlier and have more success in treating them. One such technique is Low Dose Computed Tomography (LDCT), which is currently the standard of care and surveillance at this institution. This pilot study aims to determine whether regimented, intensive, short interval LDCT surveillance leads to higher rates of detection and treatment of recurring lung cancers. The study group will be followed up according to a regimented surveillance program using LDCT. The study group will be compared to a group of historical controls whose follow up after surgery was not standardized, but rather left up to the discretion of the individual surgeon. If the results of this study show improvements in detection and treatment of recurrent cancers, it will allow for a larger trial to study the effects of the LDCT surveillance program on lung cancer survival. The study question aims to determine whether for survivors after curative surgery for Stage I and Stage II lung cancer, a structured Surveillance Program with Low Dose CT can increase the rate of detection and treatment of recurring or new cancers when compared to historical non-structured surveillance with CXR. This study will also determine if it is warranted to pursue a larger scale randomized controlled trial to further investigate optimal LDCT surveillance follow-up intervals and long-term lung cancer survival.

Conditions

Lung Neoplasms

Keywords

Retrospective Review; Pilot Study; Early Stage NSCLC; Post-Surgical Surveillance; Re-intervention Rates

Outcome Measures

Primary Outcomes (1)

• Rate of therapeutic re-intervention within the first year after curative resection of lung cancer

  Defined by: 1) rate of curative intent radiation treatment after detection of recurrent or new primary lung cancer 2) rate of curative intent reoperation after detection of recurrent or new primary lung cancer. Measured by frequency of events.

  One year after surgery

Secondary Outcomes (2)

• Rate of adherence to follow-up visits

  One year after surgery

• Morbidity of associated interventions

  One year after surgery

Study Arms (2)

LDCT Surveillance Program Group

ACTIVE COMPARATOR

This cohort will follow a strict schedule of Low Dose Computed Tomography Imaging scans and clinical visits 3, 6, and 12 months after surgery. At each encounter, a history, physical examination, and review of the LDCT results will be performed. Patients with normal clinical and imaging findings will proceed to the next scheduled clinical encounter. Patients with abnormal findings will be managed according to predetermined algorithms.

Procedure: Low Dose Computed Tomography Imaging

Historical Control Group

OTHER

The control group will be a retrospective cohort taken from 1-year before the implementation of the LDCT surveillance program. The post-operative follow-up of these participants was not standardized, but rather left up to the discretion of the individual surgeons, and involved chest radiograph imaging as opposed to Low Dose Computed Tomography.

Procedure: Chest Radiograph Imaging

Interventions

Low Dose Computed Tomography Imaging PROCEDURE

LDCT Surveillance Program Group

Chest Radiograph Imaging PROCEDURE

Historical Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be at minimum 18 years of age
• Patients must have undergone complete resection for pathological Stage I or Stage II lung cancer
• Patients must demonstrate the ability to understand English
• Patients must be able to demonstrate aptitude and willingness to comply with describes study procedures

You may not qualify if:

• Patients with residual gross or microscopic disease after surgery
• Patients with pathological Stage III or Stage IV lung cancer

Sponsors & Collaborators

• McMaster University: lead
• McMaster Surgical Associates: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wael C Hanna, MDCM MBA FRCSC FCCP

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 29, 2014
• Study Start: August 1, 2014
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)