Skip to main content
Clinical Trials/NCT03802058
NCT03802058TerminatedPhase 2

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

Wuhan University1 site in 1 country24 target enrollmentStarted: March 20, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Sponsor
Enrollment
24
Locations
1
Primary Endpoint
PFS (progression-free survival )

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Nab-paclitaxel

Experimental

Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy

Intervention: Nab-paclitaxel (Drug)

Nab-paclitaxel

Experimental

Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy

Intervention: Carboplatin (Drug)

Nab-paclitaxel

Experimental

Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy

Intervention: Thoracic radiation therapy (Radiation)

Outcomes

Primary Outcomes

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 Outcomes

  • OS (Overall survival)(5 years from patient enrollment)
  • Number of participants with adverse events as assessed by CTCAE v4.0(5 years from patient enrollment)
  • ORR (Overall Response Rate )(one month after the end of all treatment)
  • Patient quality of life (QOL)(5 years from patient enrollment)
  • LCR (Local Control Rate)(one month after the end of all treatment)

Investigators

Sponsor
Wuhan University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Conghua Xie,MD,PhD

director of Department of Radiation and Medical Oncology, Zhongnan Hospital

Wuhan University

Study Sites (1)

Loading locations...

Similar Trials