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Phase II Trial of Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III Non-Small Cell Lung Cancer
The rationale for this multicenter, phase II trial is to examine the impact of carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage IB (\> 4.0 cm), II, and select stage III NSCLC. If this novel regimen proves to be safe and active in this setting, this would provide rationale for further investigation in a larger, prospective, randomized setting.
Adjuvant chemotherapy for patients with completely resected stage II and select stage III NSCLC is considered standard therapy. At least three large, prospective randomized trials have proven the benefit of adjuvant chemotherapy in improving survival in these patients (with a magnitude of benefit ranging from 4-12%). However, in patients who are not considered to be candidates for up-front complete resection, preoperative therapy may be indicated. Many of these patients will subsequently be eligible for resection (bimodality therapy). The rationale for this multicenter, Phase II trial is to examine the impact of carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage IB (\>4.0 cm), II, and select stage III NSCLC. This trial will be conducted by the Sarah Cannon Research Institute Oncology Research Consortium. If this novel regimen proves to be safe and active in this setting, this would provide rationale for further investigation in a larger, prospective, randomized setting.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Providence Medical Group
Terre Haute, Indiana, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Portsmouth Regional Hospital
Portsmouth, New Hampshire, United States
Tennessee Oncology
Nashville, Tennessee, United States
Start Date
August 1, 2009
Primary Completion Date
November 1, 2012
Completion Date
May 1, 2013
Last Updated
December 6, 2021
4
ACTUAL participants
Carboplatin
DRUG
Paclitaxel
DRUG
Bevacizumab
DRUG
Lead Sponsor
SCRI Development Innovations, LLC
Collaborators
NCT06305754
NCT07190248
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07100080