Skip to main content
OpenTrials
Completed

NCT Number: NCT02149576

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Low Dose Computed Tomography Imaging

Procedure

Chest Radiograph Imaging

Procedure

Primary outcomes

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

    Time frame: One year after surgery

    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.

Secondary outcomes

  1. Rate of adherence to follow-up visits

    Time frame: One year after surgery

    Measured by frequency of events

  2. Morbidity of associated interventions

    Time frame: One year after surgery

    Measured by frequency of events

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • McMaster Surgical Associates

Registry information

Official study title

Does Intense Regimented Surveillance Improve the Rates of Therapeutic Re-Intervention After Lung Cancer Surgery: A Pilot Study for the Intense-CT Trial

Acronym: Intense-CT

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 29, 2014
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.