Endostar Combined With Concurrent Radiochemotherapy for Treatment of Unresectable Stage III NSCLC

• Conditions: Unresectable Stage III NSCLC

• Registration Number: NCT04161352
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

The chemoradiotherapy (CCRT) is still a standard treatment for the unresectabl stage III NSCLC.However, prognosis following this treatment is generally poor, with 5-year survival of 15-20%. The result of published HELPER study had showed that Endostar, a kind of angiogenesis agent, in combination with CCRT could improve the efficacy and safety. In order to verify the rusults, the investigators design the current study.

Detailed Description

The current study is a observation study in the real world setting. The 500 patients in compliance with Enrollment Criteria will be as the objects of observation. The procedure of study include the period of screening, treating and follow-up. The duration of study is about two and half year. The data entrying will be done by CRC, using the EDC system. CRA will audit the quality of data regularly.

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-12
• Last Update Submitted: 2019-11-12
• Study First Posted: 2019-11-13
• Last Update Posted: 2019-11-13
• Study Start: 2019-11-25
• Primary Completion: 2022-06-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• untreated pathologically confirmed inoperable stage III NSCLC according to the 8th edition of the American Joint Committee on Cancer staging system;
• at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)1.1;
• 18-75 years of age;
• Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to 1;
• 10. FEV1>1.0 L;
• suitable function of bone marrow, liver, kidney and coagulation

Exclusion Criteria

history of other malignant diseases, uncontrolled hypertension, any contraindications to chemoradiotherapy, pregnancy, breastfeeding or preexisting bleeding diatheses.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFS	15 months	progress free survival

Secondary Outcome Measures

Name	Time	Method
OS	3 years	Overall survival
DMFS	2 years	Distant metastasis-free survival
AEs	3 years	adverse events
LRFS	2 years	Locoregional relapse-free survival