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Endostar in Combination With Chemoradiotherapy in Patient With Advanced Non-small Cell Lung Cancer

NCT03588494 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2018-07-17

No results posted yet for this study

Summary

To investigate the safety and efficacy recombinant human endostatin(endostar) durative transfusion combined with cocurrent chemoradiotherapy in advanced non-small cell lung cancer(NSCLC).

Conditions

  • Quality of Life

Interventions

COMBINATION_PRODUCT

concurrent chemoradiotherapy (CCRT)

Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33. Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.

DRUG

Endostar for one cycle

Endostar(15mg/m2) was durative transfused during the normalization window of the first chemoradiotherapy cycle(days -5～-1).

DRUG

Endostar for two cycles

Endostar(15mg/m2) was durative transfused during the normalization window of the first and the second chemoradiotherapy cycles(days -5～-1 and 24～28).

Sponsors & Collaborators

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Affiliated Hospital of North Sichuan Medical College

    lead OTHER

Principal Investigators

  • Daiyuan Ma, M.D · Affiliated Hospital of North Sichuan Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-09-01
Completion
2021-09-01

Countries

  • China

Study Locations

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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 NCT03588494 on ClinicalTrials.gov