Study Stopped
The study sponsor requested the study be terminated as the existing study design did not meet their needs.
Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now
REVOLUTION
1 other identifier
observational
23
1 country
15
Brief Summary
REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to those with EGFR mutations may be enrolled following the initial study period as needed to ensure adequate sample sizes needed to examine primary questions of interest in the EGFR mutant population. Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables. The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with particular characteristics of interest including patients with adenocarcinoma, and EGFR mutations and effectively evaluate these patients with respect to key outcomes of interest including overall survival, time to progression, stage at progression, secondary metastases including brain metastases (at diagnosis and progression), comorbidity burden, and performance status at index date. The study design allows a cross-sectional perspective with collection of detailed patient and clinical characteristics at enrollment followed by longitudinal assessment of clinician and patient-reported endpoints every three months. Centralized follow-up will be conducted by having sites upload patient data following each visit via the web-based data system, with patients who do not show up for site visits being contacted via telephone by the Duke Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will be weighted based upon provider specialty and ability to enroll patients with NSCLC with the specified inclusion criteria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2016
Shorter than P25 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2016
CompletedFirst Posted
Study publicly available on registry
July 18, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2017
CompletedAugust 22, 2017
August 1, 2017
5 months
July 8, 2016
August 17, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Assessment of treatment decisions using molecular testing and results, provider decisions and patient preferences.
Characterize current practice patterns for the care of patients with NSCLC, with a special emphasis on pharmacotherapy (i.e. chemotherapy, targeted agents, and immunotherapy) and patients with EGFR mutated disease. These data will include treatment, molecular test administration and results, provider decisions and patient preferences, and explore the determinants of each.
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of progression-free survival
Compare progression-free survival, overall survival, and duration of response associated with targeted therapies, immune checkpoint inhibitors, and cytotoxic chemotherapy in NSCLC and EGFR mutated disease.
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of overall survival
Compare progression-free survival, overall survival, and duration of response associated with targeted therapies, immune checkpoint inhibitors, and cytotoxic chemotherapy in NSCLC and EGFR mutated disease.
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of treatments.
Compare of progression-free survival, overall survival, and duration of response associated with targeted therapies, immune checkpoint inhibitors, and cytotoxic chemotherapy in NSCLC and EGFR mutated disease.
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Secondary Outcomes (10)
Assessment of billing claims data.
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of patient demographics, smoking history and disease characteristics
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of patient hospitalizations.
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of targeted, immune, and cytotoxic therapies
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
Assessment of financial burden related to treatment
Time from first patient enrolled to data cut of assessed approximately every 6 months up to 72 months.
- +5 more secondary outcomes
Other Outcomes (3)
Assessment of patient treatments
Time from first patient enrolled up to 3 years.
Evaluate multiple comorbidities and low socioeconomic status
Time from first patient enrolled up to 3 years
Evaluate patients with advanced disease (e.g. multiple metastases, symptomatic disease, weight loss)
Time from first patient enrolled up to 3 years
Eligibility Criteria
Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables.
You may qualify if:
- ≥19 years of age
- Patients with a primary diagnosis of NSCLC within the past 5 years who are eligible for their first systemic therapy based on disease characteristics. Systemic therapy may include any cytotoxic, targeted, immune-based, or otherwise non-local treatment modality. Specific allowed settings include the following:
- Incident metastatic disease (stage IV) undergoing palliative therapy
- Non-metastatic disease undergoing adjuvant, neoadjuvant, or concurrent chemoradiation with either curative or palliative intent
- Recurrent or subsequently metastatic disease (any stage)
- Pathologic confirmation of malignancy prior to initiation of first systemic therapy
- Submission of archival biospecimen sample(s) (collected up to two years prior) for analysis
- Availability of key variables at the time of screening (e.g. stage, demographics)
- Have been fully informed and are able to provide written consent for longitudinal follow-up and agree to be accessible by phone
- Patients may be concurrently enrolled in unblinded clinical trials, but not blinded clinical trials in which the treatment being administered is unknown
You may not qualify if:
- Pre-specified enrollment caps have been met (Figure 1)
- Suspected recurrent or subsequently metastatic disease that is not biopsy confirmed prior to receipt of initial systemic therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (15)
Research Site
Monterey, California, United States
Research Site
Santa Rosa, California, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Denver, Colorado, United States
Research Site
Chicago, Illinois, United States
Research Site
Urbana, Illinois, United States
Research Site
Southfield, Michigan, United States
Research Site
Duluth, Minnesota, United States
Research Site
Rochester, Minnesota, United States
Research Site
Jackson, Mississippi, United States
Research Site
Omaha, Nebraska, United States
Research Site
Rock Hill, South Carolina, United States
Research Site
Germantown, Tennessee, United States
Research Site
Newport News, Virginia, United States
Research Site
Tacoma, Washington, United States
Related Links
Biospecimen
Archived residual specimens will be requested from appropriate institution for each patient at consent. One block or 20 slides (if block is not available) will be requested for each patient for molecular testing and sent as directed by the Lab Manual. Specimens will be banked at the Carolinas HealthCare Biospecimen Repository (CHS BSR) specifically for this protocol in their Clinical Trials Management System Biospecimen Module (CTMS BSM).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffery Crawford, MD
Duke Clinical Research Institute
- STUDY CHAIR
Edward Kim, MD
Atrium Health Levine Cancer Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2016
First Posted
July 18, 2016
Study Start
November 1, 2016
Primary Completion
April 6, 2017
Study Completion
April 6, 2017
Last Updated
August 22, 2017
Record last verified: 2017-08