Status:
UNKNOWN
Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer
Lead Sponsor:
First People's Hospital of Hangzhou
Conditions:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for sq...
Detailed Description
This study was conducted to explore the efficacy and toxicity of concurrent chemoradiotherapy with nab-paclitaxel, carboplatin and thoracic radiotherapy in unresectable local advanced squamous cell lu...
Eligibility Criteria
Inclusion
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- 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
- Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
- 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.
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2017
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01494415
Start Date
July 1 2012
End Date
June 1 2017
Last Update
December 15 2015
Active Locations (2)
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1
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China, 310002
2
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China, 310006