Spots Global Cancer Trial Database for Predictive Assay for Decision Making in Adjuvant Therapy
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Trial Identification
Brief Title: Predictive Assay for Decision Making in Adjuvant Therapy
Official Title: Predictive Assay for Decision Making in Adjuvant Therapy (PADMA)
Study ID: NCT05032352
Conditions
Study Description
Brief Summary: Prospective Registrational Trial to Define Real World Outcomes of Patients with Completely Resected Stage I or IIA (tumor \< or = 5cm, node negative) Non-squamous Non-Small Lung Cancer (NSCLC) Identified as High, Intermediate, or Low Risk by a 14-Gene Prognostic Assay DetermaRx being Considered for Adjuvant Platinum-based chemotherapy or other adjuvant therapy versus Observation
Detailed Description: This is a prospective, non-randomized, 2 arm, multi-center study in patients with histologically documented non-squamous NSCLC who have undergone complete resection (R0) of the primary tumor with pathologically stage I or IIA disease. Routine paraffin-embedded tumor specimens from completely resected (R0) stage I or IIA patients with non-squamous NSCLC will undergo testing with the DetermaRx 14-Gene Prognostic Assay and will be designated as HIGH, INTERMEDIATE or LOW risk by the assay. The physician and patient will determine the best treatment course and will be assigned to treatment arm based on decision of adjuvant therapy or observation: 1. Adjuvant treatment with a standard NSCLC platin-based doublet, 4 cycle (21-day) regimen of the investigator's choice (Arm 1) or other adjuvant therapy (Arm 1a) which can include combination of chemotherapy and targeted therapy, immunotherapy or other. 2. Observation (Arm 2) All patients will be observed for progression free survival and overall survival to the end of study or death, whichever occurs first. All patients will be observed for disease free survival and overall survival to the end of study or death, whichever occurs first
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
MedStar Washington Hospital Center, Washington, District of Columbia, United States
George Washington Medical Faculty Associates, Washington, District of Columbia, United States
Jupiter Medical Center, Jupiter, Florida, United States
Piedmont Cancer Center, Atlanta, Georgia, United States
Northshore University Healthsystem, Evanston, Illinois, United States
The University of Kansas Hospital, Kansas City, Kansas, United States
Our Lady of the Lake Regional Medical Center, Baton Rouge, Louisiana, United States
Penn Presbyterian Medical Center, Philadelphia, Pennsylvania, United States
Texas Oncology-San Antonio Medical Center, San Antonio, Texas, United States
Methodist Healthcare, San Antonio, Texas, United States
Texas Oncology-Wichita Falls Cancer Center, Wichita Falls, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Mary Washington Hospital, Fredericksburg, Virginia, United States
Providence Regional Medical Center Everett, Everett, Washington, United States
Peace Health, Vancouver, Washington, United States
West Virginia University Medicine, Morgantown, West Virginia, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Corey Langer, MD
Affiliation:
Role: PRINCIPAL_INVESTIGATOR
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