Endostar Combined With Concurrent Radiochemotherapy for Treatment of Unresectable Stage III NSCLC (R-helper)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Unresectable Stage III NSCLC

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Ming Chen, Doctor; Phone Number: 18758875572; Email: chenming@zjcc.org.cn
• Study Contact Backup: Name: Honglian Ma, Doctor; Phone Number: 18758871656; Email: mahl@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progress free survival	15 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 25, 2019
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Endo-CCRT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Only principlal investigator has the right to use all the data collected. The individual participant will not be allowed to share the data among them.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No