Clinical trial NCT02149576: Does Intense Regimented Surveillance Improve the Rates of Therapeutic Re-Intervention After Lung Cancer Surgery
Official title: Does Intense Regimented Surveillance Improve the Rates of Therapeutic Re-Intervention After Lung Cancer Surgery: A Pilot Study for the Intense-CT Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Neoplasms
Keywords: Retrospective Review
Pilot Study
Early Stage NSCLC
Post-Surgical Surveillance
Re-intervention Rates
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster Surgical Associates
First posted: 2014-05-29
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of therapeutic re-intervention within the first year after curative resection of lung cancer
timeFrame: One year after surgery
Secondary outcomes:
measure: Rate of adherence to follow-up visits
timeFrame: One year after surgery
measure: Morbidity of associated interventions
timeFrame: One year after surgery
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Wael C Hanna, MDCM MBA FRCSC FCCP
role: PRINCIPAL_INVESTIGATOR
References: