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

NCT03802058 | Terminated Phase 2

• 1 other identifier: Nab-P RT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years from patient enrollment

Secondary Outcomes (5)

• ORR (Overall Response Rate )

  one month after the end of all treatment

• LCR (Local Control Rate)

  one month after the end of all treatment

• 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

• Patient quality of life (QOL)

  5 years from patient enrollment

Study Arms (1)

Nab-paclitaxel

EXPERIMENTAL

Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy

Drug: Nab-paclitaxel; Drug: Carboplatin; Radiation: Thoracic radiation therapy

Interventions

Nab-paclitaxel DRUG

Nab-paclitaxel 40mg/m2 for Injection weekly

Also known as: Nab-P

Nab-paclitaxel

Carboplatin DRUG

Carboplatin AUC=2 for Injection weekly

Also known as: CBP

Nab-paclitaxel

Thoracic radiation therapy RADIATION

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

Also known as: RT

Nab-paclitaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wuhan University: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Conditions

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

Interventions

130-nm albumin-bound paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Conghua Xie, Dr

  Wuhan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Department of Radiation and Medical Oncology, Zhongnan Hospital

Study Record Dates

• First Submitted: January 6, 2019
• First Posted: January 14, 2019
• Study Start: March 20, 2019
• Primary Completion: December 12, 2021
• Study Completion: December 12, 2021
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 years after the end of the study
• Access Criteria: Researchers who participate in this study

Locations

CN (1)