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

Unresectable Stage III NSCLC Clinical Trial

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Official title:

A Multicenter, Prospective Real World Study on Recombinant Human Endostatin (Endostar) Combined With Concurrent Radiochemotherapy for Treatment of Unresectable Stage III Non-small-cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04161352
• Other study ID #: Endo-CCRT-001
• Status: Not yet recruiting
• Start date: November 25, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2019
• Source: Zhejiang Cancer Hospital
• Contact: Ming Chen, Doctor
• Phone: 18758875572
• Email: chenming[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Unresectable Stage III NSCLC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	progress free survival	15 months
Secondary	OS	Overall survival	3 years
Secondary	LRFS	Locoregional relapse-free survival	2 years
Secondary	DMFS	Distant metastasis-free survival	2 years
Secondary	AEs	adverse events	3 years