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

NCT ID: NCT03802058

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2021-12-12

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nab-paclitaxel

Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy

Group Type: EXPERIMENTAL

Nab-paclitaxel

Intervention Type: DRUG

Nab-paclitaxel 40mg/m2 for Injection weekly

Carboplatin

Intervention Type: DRUG

Carboplatin AUC=2 for Injection weekly

Thoracic radiation therapy

Intervention Type: RADIATION

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

Interventions

Nab-paclitaxel

Nab-paclitaxel 40mg/m2 for Injection weekly

Intervention Type: DRUG

Carboplatin

Carboplatin AUC=2 for Injection weekly

Intervention Type: DRUG

Thoracic radiation therapy

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

Intervention Type: RADIATION

Other Intervention Names

Nab-P; CBP; RT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Conghua Xie,MD,PhD

director of Department of Radiation and Medical Oncology, Zhongnan Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Conghua Xie, Dr

Role: PRINCIPAL_INVESTIGATOR

Wuhan University

Locations

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Countries

China

Other Identifiers

Nab-P RT

Identifier Type: -

Identifier Source: org_study_id