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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04161352

Acronym

R-helper

Enrollment

500

Registered

2019-11-13

Start date

2019-11-25

Completion date

2023-12-30

Last updated

2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable Stage III NSCLC

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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. \-

Design outcomes

Primary

Measure	Time frame	Description
PFS	15 months	progress free survival

Secondary

Measure	Time frame	Description
OS	3 years	Overall survival
LRFS	2 years	Locoregional relapse-free survival
DMFS	2 years	Distant metastasis-free survival
AEs	3 years	adverse events

Contacts

Primary ContactMing Chen, Doctor

chenming@zjcc.org.cn18758875572

Backup ContactHonglian Ma, Doctor

mahl@zjcc.org.cn18758871656

Outcome results