Study Summary
This trial is testing whether post-operative chemotherapy is better than radiographic surveillance for stage I or stage IIA non-small cell lung cancer patients.
- Non-Small Cell Lung Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 5 years
Trial Safety
Trial Design
2 Treatment Groups
Adjuvant Chemotherapy
1 of 2
Observation
1 of 2
Active Control
1050 Total Participants · 2 Treatment Groups
Primary Treatment: Adjuvant Chemotherapy · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Kratz, Johannes R., Stephen K. Van Den Eeden, Jianxing He, David M. Jablons, and Michael J. Mann. 2012. “A Prognostic Assay to Identify Patients at High Risk of Mortality Despite Small, Node-negative Lung Tumors”. Jama. American Medical Association (AMA). doi:10.1001/jama.2012.13551.
- Kratz, Johannes R, Jianxing He, Stephen K Van Den Eeden, Zhi-Hua Zhu, Wen Gao, Patrick T Pham, Michael S Mulvihill, et al.. 2012. “A Practical Molecular Assay to Predict Survival in Resected Non-squamous, Non-small-cell Lung Cancer: Development and International Validation Studies”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(11)61941-7.
- Woodard, Gavitt A., Sue X. Wang, Johannes R. Kratz, Clara T. Zoon-Besselink, Chun-Yuan Chiang, Matthew A. Gubens, Thierry M. Jahan, et al.. 2018. “Adjuvant Chemotherapy Guided by Molecular Profiling and Improved Outcomes in Early Stage, Non–small-cell Lung Cancer”. Clinical Lung Cancer. Elsevier BV. doi:10.1016/j.cllc.2017.05.015.
- Kratz JR, Van den Eeden SK, He J, Jablons DM, Mann MJ. A prognostic assay to identify patients at high risk of mortality despite small, node-negative lung tumors. JAMA. 2012 Oct 24;308(16):1629-31. doi: 10.1001/jama.2012.13551. No abstract available.
- 2020. "Adjuvant Chemotherapy in Patients With Intermediate or High Risk Stage I or Stage IIA Non-squamous Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01817192.
Frequently Asked Questions
Are there various venues where this experiment is being conducted in the state?
"Allegheny Health Network Research Institute in Pittsburgh, Pennsylvania, Mercy Oncology Research St. Louis in Saint Louis, Missouri and Highlands Oncology Group in Springdale, Arkansas are all participating sites for this research trial; 20 other medical centres have been recruited as well." - Anonymous Online Contributor
Is there any remaining availability to join this medical experiment?
"This experiment, first introduced on the 11th of September 2020 and updated most recently on the 1st November 2022, is presently seeking new participants according to data available on clinicaltrials.gov." - Anonymous Online Contributor
What is the current sample size of individuals participating in this clinical trial?
"The sponsor, Razor Genomics, has identified a need for 1050 participants that meet the study's eligibility requirements. The trial will operate out of Allegheny Health Network Research Institute in Pittsburgh and Mercy Oncology Research St. Louis within Missouri." - Anonymous Online Contributor