Clinical trial NCT01211002: Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin for Local Advanced Non-small Cell Lung Cancer (NSCLC)
Official title: The Exploratory Clinical Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin (Endostar) for Local Advanced Non-small Cell Lung Cancer (NSCLC (Ⅲ A / Ⅲ B) )
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-small Cell Lung Cancer
Keywords: Radiotherapy
rh-endostatin
chemotherapy
NSCLC
Lead sponsor: Simcere Pharmaceutical Co., Ltd
Sponsor class: OTHER
Collaborators: name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
First posted: 2010-09-29
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a trials to evaluate the overall survival (OS) of radiotherapy / EP combined with recombinant human endostatin in treatment of locally advanced (Ⅲ A / unresectable Ⅲ B) non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

1. Patients with pathologically or histologically confirmed and inoperable stage Ⅲ (Ⅲ A or unresectable Ⅲ B) NSCLC;
2. Patients with ages of 18\~70 years, general condition ECOG performance scale （PS）≤ 1, weight loss \<10% during last 6 months;
3. CT films of patients during last 4 weeks were accessible when patients were selected into the groups, the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, PET-CT, with the largest diameter≥ 20mm by ordinary CT and MRI.）
4. No major organ dysfunction, the function of heart, liver and kidney was normal, laboratory indicators should meet the following requirements: Blood: WBC\> 4.0 × 109 / L, absolute neutrophil count \> 1.5 × 109 / L, platelet count\> 100 × 109 / L, hemoglobin\> 110g / L; liver function: serum bilirubin was less than 1.5 × maximum normal value ; ALT and AST were less than 1.5 × maximum normal value; BUN, Cr within the normal range; FEV1 \> 1L or\> 40% of predicted value;
5. Patients could understand the circumstances of this study and those who have signed the informed consent form;

Exclusion Criteria:

1. Pregnant or lactating women; women of child-bearing age without contraception;
2. Acute infection or other serious underlying diseases;
3. Significant neurological, psychiatric history, including dementia which may influence the ability to understand and the informed consent;
4. Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs a the same time; have joined other drug clinical trials 30 days before this clinical trial;
5. Diabetes without control (blood-glucose is unstable or ≥ 8mol / L after administration);
6. Patients who are allergic to E. coli preparation;
7. Patients who are unsuitable to participate in this trial determined by the researchers.

Primary outcomes:
measure: overall survival (OS)
timeFrame: 3 years
Secondary outcomes:
measure: quality of life
timeFrame: 2 years
measure: objective response rate (ORR)
timeFrame: 1 years
measure: disease control rate (DCR)
timeFrame: 1 year
measure: progression-free survival (PFS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Chongqin
country: China
facility: Daping Hospital
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: zhenzhou yang, M.D.
role: STUDY_CHAIR
References: