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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802058
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
CSPC Ouyi Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Conghua Xie,MD,PhD, Wuhan University

Tracking Information
First Submitted Date  ICMJE January 6, 2019
First Posted Date  ICMJE January 14, 2019
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE March 20, 2019
Estimated Primary Completion Date May 6, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
PFS (progression-free survival ) [ Time Frame: 5 years from patient enrollment ]
PFS is defined as time from the start of treatment to death, progression of disease, or the last follow-up data, whichever comes first. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. PFS will be analyzed using the Kaplan-Meier method.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
  • ORR (Overall Response Rate ) [ Time Frame: one month after the end of all treatment ]
    The number of participants that achieve either a complete response (CR) or a partial response (PR). Response is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  • LCR (Local Control Rate) [ Time Frame: one month after the end of all treatment ]
    The number of participants that achieve either a complete response (CR) , a partial response (PR) or stable disease(SD).
  • OS (Overall survival) [ Time Frame: 5 years from patient enrollment ]
    Overall survival is defined as time from the start of treatment until death. Overall survival will be analyzed using the Kaplan-Meier method.
  • Number of participants with adverse events as assessed by CTCAE v4.0 [ Time Frame: 5 years from patient enrollment ]
    The adverse events(AE) is evaluated by National Cancer Institute- Common Terminology Criteria for Adverse Events(NCI -CTCAE) 4.02.
  • Patient quality of life (QOL) [ Time Frame: 5 years from patient enrollment ]
    Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L).The total range of scores:0-144,and higher values represent a better outcome.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer
Official Title  ICMJE Concurrent Nab--paclitaxel/Carboplatin and Thoracic Radiotherapy in Inoperable Stage III Squamous Cell Lung Cancer
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 squamous cell cancer. This study is conducted to evaluate the efficacy and safety of nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced inoperable squamous cell lung cancer.
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. Patients will be given nab-paclitaxel weekly at a dose of 40mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 60-66 Gy/30-33 fractions, both 3 dimensional conformal and intensity modulated radiation therapy are allowed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Non-Small-Cell Lung
  • Squamous Cell Carcinoma
Intervention  ICMJE
  • Drug: Nab-paclitaxel
    Nab-paclitaxel 40mg/m2 for Injection weekly
    Other Name: Nab-P
  • Drug: Carboplatin
    Carboplatin AUC=2 for Injection weekly
    Other Name: CBP
  • Radiation: Thoracic radiation therapy
    Thoracic radiation therapy 60-66Gy/30-33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed
    Other Name: RT
Study Arms  ICMJE Experimental: Nab-paclitaxel
Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy
Interventions:
  • Drug: Nab-paclitaxel
  • Drug: Carboplatin
  • Radiation: Thoracic radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 9, 2019)
138
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 6, 2022
Estimated Primary Completion Date May 6, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Conghua Xie, Dr 0086-27-67812607 chxie_65@whu.edu.cn
Contact: Wen Ouyang, Dr 0086-27-67812607 wen19860213@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03802058
Other Study ID Numbers  ICMJE Nab-P RT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: all IPD can be shared by all researchers who participate in this study by e-mail contact
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: 2 years after the end of the study
Access Criteria: Researchers who participate in this study
Responsible Party Conghua Xie,MD,PhD, Wuhan University
Study Sponsor  ICMJE Wuhan University
Collaborators  ICMJE CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators  ICMJE
Principal Investigator: Conghua Xie, Dr Wuhan University
PRS Account Wuhan University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP