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

Primary Purpose

Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma

Status

Terminated

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nab-paclitaxel

Carboplatin

Thoracic radiation therapy

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Zhongnan Hospital of Wuhan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nab-paclitaxel

Arm Description

Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy

Outcomes

Primary Outcome Measures

PFS (progression-free survival )

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

ORR (Overall Response Rate )

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)

The number of participants that achieve either a complete response (CR) , a partial response (PR) or stable disease(SD).

OS (Overall survival)

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

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)

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.

Full Information

NCT ID

NCT03802058

First Posted

January 6, 2019

Last Updated

April 27, 2023

Sponsor

Wuhan University

Collaborators

CSPC Ouyi Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03802058

Brief Title

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

Official Title

Concurrent Nab--paclitaxel/Carboplatin and Thoracic Radiotherapy in Inoperable Stage III Squamous Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Terminated

Why Stopped

The study was halted because enrollment was too slow

Study Start Date

March 20, 2019 (Actual)

Primary Completion Date

December 12, 2021 (Actual)

Study Completion Date

December 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wuhan University

Collaborators

CSPC Ouyi Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nab-paclitaxel

Arm Type

Experimental

Arm Description

Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel

Other Intervention Name(s)

Nab-P

Intervention Description

Nab-paclitaxel 40mg/m2 for Injection weekly

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

CBP

Intervention Description

Carboplatin AUC=2 for Injection weekly

Intervention Type

Radiation

Intervention Name(s)

Thoracic radiation therapy

Other Intervention Name(s)

Intervention Description

Thoracic radiation therapy 60-66Gy/30-33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed

Primary Outcome Measure Information:

Title

PFS (progression-free survival )

Description

Time Frame

5 years from patient enrollment

Secondary Outcome Measure Information:

Title

ORR (Overall Response Rate )

Description

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.

Time Frame

one month after the end of all treatment

Title

LCR (Local Control Rate)

Description

The number of participants that achieve either a complete response (CR) , a partial response (PR) or stable disease(SD).

Time Frame

one month after the end of all treatment

Title

OS (Overall survival)

Description

Overall survival is defined as time from the start of treatment until death. Overall survival will be analyzed using the Kaplan-Meier method.

Time Frame

5 years from patient enrollment

Title

Number of participants with adverse events as assessed by CTCAE v4.0

Description

The adverse events(AE) is evaluated by National Cancer Institute- Common Terminology Criteria for Adverse Events(NCI -CTCAE) 4.02.

Time Frame

5 years from patient enrollment

Title

Patient quality of life (QOL)

Description

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.

Time Frame

5 years from patient enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Conghua Xie, Dr

Organizational Affiliation

Wuhan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongnan Hospital of Wuhan University

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430071

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

all IPD can be shared by all researchers who participate in this study by e-mail contact

IPD Sharing Time Frame

2 years after the end of the study

IPD Sharing Access Criteria

Researchers who participate in this study

Learn more about this trial

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

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