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

Wuhan University

Status and phase

Terminated

Phase 2

Conditions

Squamous Cell Carcinoma

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Nab-paclitaxel

Radiation: Thoracic radiation therapy

Drug: Carboplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03802058

Nab-P RT

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.