Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer
NCT ID: NCT01494415
Last Updated: 2015-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
21 participants
INTERVENTIONAL
2012-07-31
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
chemoradiotherapy
This is a single arm study with patients receiving nab-paclitaxel, carboplatin and thoracic radiotherapy.
Paclitaxel for Injection（Albumin Bound）
concurrent: 60 mg/m2, IV, weekly; consolidation: 260 mg/m2, IV, every 3 weeks
carboplatin
concurrent: AUC 2, IV, weekly; consolidation: AUC 6, IV, every 3 weeks
thoracic radiation therapy
66 Gy in 33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Paclitaxel for Injection（Albumin Bound）
concurrent: 60 mg/m2, IV, weekly; consolidation: 260 mg/m2, IV, every 3 weeks
carboplatin
concurrent: AUC 2, IV, weekly; consolidation: AUC 6, IV, every 3 weeks
thoracic radiation therapy
66 Gy in 33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Previously untreated, histological documented, inoperable stage IIIA or IIIB squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
* Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.
* Weight loss ≦ 5% in the previous six months.
* Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
* Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
* Patients must sign a study-specific informed consent form prior to study entry.
Exclusion Criteria
* Previous chemotherapy or previous biologic response modifiers for current lung cancer.
* Patient has previously had thoracic radiation therapy.
* Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
* Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
* History of significant neurological or mental disorder, including seizures or dementia.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
First People's Hospital of Hangzhou
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Shenglin Ma
President of the hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shenglin Ma, MD
Role: PRINCIPAL_INVESTIGATOR
The First People's Hospital of Hangzhou
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Bing Xia, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HZFH CA11-01
Identifier Type: -
Identifier Source: org_study_id