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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

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Squamous Cell Carcinoma Drug: Nab-paclitaxel Drug: Carboplatin Radiation: Thoracic radiation therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Concurrent Nab--paclitaxel/Carboplatin and Thoracic Radiotherapy in Inoperable Stage III Squamous Cell Lung Cancer
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : May 6, 2022
Estimated Study Completion Date : November 6, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nab-paclitaxel
Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802058


Contacts
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Contact: Conghua Xie, Dr 0086-27-67812607 chxie_65@whu.edu.cn
Contact: Wen Ouyang, Dr 0086-27-67812607 wen19860213@163.com

Locations
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China, Hubei
Zhongnan Hospital of Wuhan University Recruiting
Wuhan, Hubei, China, 430071
Contact: Conghua Xie, Dr    0086-27-67812607    chxie_65@whu.edu.cn   
Contact: Wen Ouyang, Dr    0086-27-67812607    wen19860213@163.com   
Principal Investigator: Conghua Xie, Dr         
Sub-Investigator: Wen Ouyang, Dr         
Sponsors and Collaborators
Wuhan University
CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Conghua Xie, Dr Wuhan University
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Responsible Party: Conghua Xie,MD,PhD, director of Department of Radiation and Medical Oncology, Zhongnan Hospital, Wuhan University
ClinicalTrials.gov Identifier: NCT03802058    
Other Study ID Numbers: Nab-P RT
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 2 years after the end of the study
Access Criteria: Researchers who participate in this study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action