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

Lung Neoplasms Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149576
• Other study ID #: SJHH_IntenseCT_Pilot
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2014
• Est. completion date: April 30, 2018

Study information

• Verified date: December 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Procedure:
• Low Dose Computed Tomography Imaging

• Chest Radiograph Imaging

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	McMaster Surgical Associates

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of adherence to follow-up visits	Measured by frequency of events	One year after surgery
Secondary	Morbidity of associated interventions	Measured by frequency of events	One year after surgery