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Study of Radiotherapy Combined With Albumin Bound Paclitaxel and Nedaplatin for Locally Advanced NSCLC

NCT04524299 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2020-08-24

No results posted yet for this study

Summary

This phase II randomized study is to investigate the efficacy and toxicity of fractional thoracic radiotherapy combined with albumin bound paclitaxel and nedaplatin twice a week in the treatment of locally advanced non-small cell lung cancer compared with weekly chemotherapy.

Conditions

Interventions

RADIATION

chest radiation(IMRT)

Patients will receive intensity modulated radiotherapy (IMRT) once a day, 5 days a week. The first stage: DT 3000 cGy / 6 FX; the second stage, DT 3500 cGy / 7 FX. Or: the first segment: DT 4000 cGy / 10 FX; the second segment DT 2400 cGy / 6 FX. The interval between two stages of radiotherapy was 4 weeks.

DRUG

Concurrent chemotherapy twice a week

During the same period of radiotherapy, 30 mg / m2 albumin bound paclitaxel was intravenously infused twice a week for 0.5 hours, and nedaplatin 10 mg / m2 twice a week for 0.5 hours. 1. When the radiotherapy dose was 3000 cGy / 6 FX + DT 3500 cGy / 7 FX, the infusion time was D1, D4, D8 of the first stage of radiotherapy; D1, D4, D8 of the second stage of radiotherapy. 2. When the radiotherapy dose was 4000 cGy / 10 FX + DT 2400 cGy / 6 FX, the infusion time was D1, D4, D8, D11 of the first stage of radiotherapy; D1, D4, D8 of the second stage of radiotherapy

DRUG

Concurrent chemotherapy once a week

During the same period of radiotherapy, albumin bound paclitaxel (50 mg / m2) was intravenously infused once a week for 0.5 hours; nedaplatin (25 mg / m2) was intravenously infused once a week for 0.5 hours. The infusion time was D1, D8 of the first radiotherapy and D1, D8 of the second radiotherapy.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Hui Liu, Prof. · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-05-31
Completion
2024-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04524299 on ClinicalTrials.gov