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

NCT04161352 | Unknown

• 1 other identifier: Endo-CCRT-001
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Unresectable Stage III NSCLC

Outcome Measures

Primary Outcomes (1)

• PFS

  progress free survival

  15 months

Secondary Outcomes (4)

• OS

  3 years

• LRFS

  2 years

• DMFS

  2 years

• AEs

  3 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the patients with untreated pathologically confirmed inoperable stage III NSCLC, suitable for the treatment of CCRT

You may qualify if:

• 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;
• years of age;
• Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to 1;
• \) FEV1\>1.0 L;
• suitable function of bone marrow, liver, kidney and coagulation

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Central Study Contacts

Ming Chen, Doctor

CONTACT

18758875572; chenming@zjcc.org.cn

Honglian Ma, Doctor

CONTACT

18758871656; mahl@zjcc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: November 25, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2023
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share