Status:

TERMINATED

Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer

Lead Sponsor:

Wuhan University

Collaborating Sponsors:

CSPC Ouyi Pharmaceutical Co., Ltd.

Conditions:

Carcinoma, Non-Small-Cell Lung

Squamous Cell Carcinoma

Eligibility:

All Genders

18-70 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 safety of concurrent concurrent nab-paclitaxel, carboplatin and thoracic radiotherapy in inoperable local advanced squamous cell lung cancer. Patie...

Eligibility Criteria

Inclusion

  • Age: 18 Years to 70 Years
  • Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
  • Previously untreated, histological documented, inoperable stage III 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.
  • 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 :

March 20 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 12 2021

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT03802058

Start Date

March 20 2019

End Date

December 12 2021

Last Update

April 28 2023

Active Locations (1)

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1

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China, 430071