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

Primary Purpose

Lung Neoplasms

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Low Dose Computed Tomography Imaging
Chest Radiograph Imaging
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Neoplasms focused on measuring Retrospective Review, Pilot Study, Early Stage NSCLC, Post-Surgical Surveillance, Re-intervention Rates

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

LDCT Surveillance Program Group

Historical Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of adherence to follow-up visits
Measured by frequency of events
Morbidity of associated interventions
Measured by frequency of events

Full Information

First Posted
May 20, 2014
Last Updated
December 19, 2018
Sponsor
McMaster University
Collaborators
McMaster Surgical Associates
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1. Study Identification

Unique Protocol Identification Number
NCT02149576
Brief Title
Does Intense Regimented Surveillance Improve the Rates of Therapeutic Re-Intervention After Lung Cancer Surgery
Acronym
Intense-CT
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
McMaster Surgical Associates

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
Keywords
Retrospective Review, Pilot Study, Early Stage NSCLC, Post-Surgical Surveillance, Re-intervention Rates

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
313 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LDCT Surveillance Program Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Historical Control Group
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Low Dose Computed Tomography Imaging
Intervention Type
Procedure
Intervention Name(s)
Chest Radiograph Imaging
Primary Outcome Measure Information:
Title
Rate of therapeutic re-intervention within the first year after curative resection of lung cancer
Description
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.
Time Frame
One year after surgery
Secondary Outcome Measure Information:
Title
Rate of adherence to follow-up visits
Description
Measured by frequency of events
Time Frame
One year after surgery
Title
Morbidity of associated interventions
Description
Measured by frequency of events
Time Frame
One year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wael C Hanna, MDCM MBA FRCSC FCCP
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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