Lung NeoplasmsPhase 2Intense-CTNCT02149576
Does Intense Regimented Surveillance Improve the Rates of Therapeutic Re-Intervention After Lung Cancer Surgery
A Phase 2 study testing Low Dose Computed Tomography Imaging and Chest Radiograph Imaging in people with Lung Neoplasms, run by McMaster University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Low Dose Computed Tomography Imaging and Chest Radiograph Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2014to 30 Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with residual gross or microscopic disease after surgery
- Patients with pathological Stage III or Stage IV lung cancer
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Low Dose Computed Tomography Imaging, Chest Radiograph Imaging
- Keywords
- Retrospective Review, Pilot Study, Early Stage NSCLC, Post-Surgical Surveillance, Re-intervention Rates
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose Computed Tomography ImagingProcedure or surgery
Chest Radiograph ImagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Chest Radiograph Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year after surgery
Secondary outcomes (2)
Rate of adherence to follow-up visits
Measured by frequency of events
Measured: One year after surgery
Morbidity of associated interventions
Measured by frequency of events
Measured: One year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study start1 Aug 2014
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster Surgical Associates
- Responsible party
- Sponsor
- Investigators
- Wael C Hanna, MDCM MBA FRCSC FCCP, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149576
- Sponsor's protocol ID
- SJHH_IntenseCT_Pilot
- Acronym
- Intense-CT
- Status last verified
- Dec 2018
- First submitted
- 20 May 2014
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02149576
- Acronym / sponsor ID
- Intense-CT / SJHH_IntenseCT_Pilot
- Conditions
- Lung Neoplasms
- Keywords
- Retrospective Review, Pilot Study, Early Stage NSCLC, Post-Surgical Surveillance, Re-intervention Rates
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- McMaster Surgical Associates
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LDCT Surveillance Program Group | Active comparator | Procedure: Low Dose Computed Tomography ImagingThis 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. |
| Historical Control Group | Other | Procedure: Chest Radiograph ImagingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with residual gross or microscopic disease after surgery
- Patients with pathological Stage III or Stage IV lung cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose Computed Tomography Imaging | Procedure or surgery | LDCT Surveillance Program Group |
| Chest Radiograph Imaging | Procedure or surgery | Historical Control Group |
Primary outcome
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.
2 secondary outcomes
Rate of adherence to follow-up visits
Time frame: One year after surgery
Morbidity of associated interventions
Time frame: One year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael C Hanna, MDCM MBA FRCSC FCCP principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low Dose Computed Tomography Imaging and Chest Radiograph Imaging in people with Lung Neoplasms, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of therapeutic re-intervention within the first year after curative resection of lung cancer (time frame: One year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.