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A Phase II Study of Concurrent Nab-Paclitaxel, Carboplatin and Thoracic Radiotherapy in Local Advanced Squamous Cell Lung Cancer

Phase 2
18 Years
75 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell

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Trial Information

A Phase II Study of Concurrent Nab-Paclitaxel, Carboplatin and Thoracic Radiotherapy in Local Advanced Squamous Cell Lung Cancer

This study was conducted to explore the efficacy and toxicity of concurrent
chemoradiotherapy with nab-paclitaxel, carboplatin and thoracic radiotherapy in unresectable
local advanced squamous cell lung cancer. Patients will be given nab-paclitaxel weekly at a
dose of 60mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent
chemoradiotherapy. Thoracic radiation was administered at a dose of 66 Gy/33 fractions, both
3 dimensional conformal and intensity modulated radiation therapy are allowed. Two cycles of
consolidation therapy with full dose nab-paclitaxel (260 mg/m2 on day 1) and carboplatin
(AUC 6 on day 1) every 21 day will be delivered.

Inclusion Criteria:

- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.

- Previously untreated, histological documented, inoperable stage IIIA or IIIB 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.

- Weight loss ≦ 5% in the previous six months.

- 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

- 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

- History of significant neurological or mental disorder, including seizures or

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

tumor response rate

Outcome Time Frame:

one month after the end of all treatment

Safety Issue:


Principal Investigator

Shenglin Ma, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The First People's Hospital of Hangzhou


China: Ethics Committee

Study ID:

HZFH CA11-01



Start Date:

January 2012

Completion Date:

June 2014

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Squamous Cell Lung Cancer
  • radiation therapy
  • chemotherapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Lung Neoplasms