Clinical trial NCT03588494: Endostar in Combination With Chemoradiotherapy in Patient With Advanced Non-small Cell Lung Cancer
Official title: Recombinant Human Endostatin (Endostar) Combined With Concurrent Chemoradiotherapy for Advanced Non-small Cell Lung Cancer: A Multicenter, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Quality of Life
Keywords: Recombinant human endostatin
NSCLC
chemoradiotherapy
Lead sponsor: Afﬁliated Hospital of North Sichuan Medical College
Sponsor class: OTHER
Collaborators: name: Jiangsu Simcere Pharmaceutical Co., Ltd.
First posted: 2018-07-17
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly assigned to a regimen of W1-CCRT(one treatment cycle of intravenous pump of recombinant human endostatin before chemoradiotherapy), or W2-CCRT(two treatment cycle of intravenous pump of recombinant human endostatin before chemoradiotherapy), or CCRT.
Primary purpose: TREATMENT

Brief summary: To investigate the safety and efficacy recombinant human endostatin(endostar) durative transfusion combined with cocurrent chemoradiotherapy in advanced non-small cell lung cancer(NSCLC).


Eligibility criteria: Inclusion Criteria:

* 1. Male or female patients, age: 18-70 years of age
* 2. Pathology was diagnosed as non-small cell lung cancer. According to the Tumor Node Metastasis（TNM）stage of the 8th edition of the International Association for the Study of Lung Cancer in 2017, And the pathological stage was identified as stage IIIa-b.
* 3. No previous chest radiotherapy and radiotherapy, immunotherapy or biological therapy.
* 4. Eastern Cooperative Oncology Group (ECOG) test scored 0-1.
* 5. Serum hemoglobin ≥ 100g/L, platelet ≥ 100 × 109/L, absolute number of neutrophils ≥ 1.5 × 109/L.
* 6. Serum creatinine ≤ 1.25 times the upper limit of normal(UNL) or creatinine clearance ≥ 60 mL/min.
* 7. Serum bilirubin ≤ 1.5 times UNL, Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL.
* 8. Forced vital capacity rate of one second（FEV1）\>0.8 litre.
* 9. Coagulation function is normal
* 10. lesions are measurable according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST1.1)standard
* 11. Sign the inform consent form with good compliance

Exclusion Criteria:

* 1. Carcinoid or small cell lung cancer
* 2. Patients with any distant metastasis
* 3. patients with previous or current malignancy, except for skin non-melanoma or carcinoma in situ in the cervix
* 4. Any other disease or condition is a contraindication to chemoradiation (eg, active infection, 6 months after myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy).
* 5. Pregnancy or breastfeeding women
* 6. Women who may be pregnant but are unwilling to take appropriate contraception
* 7. Hereditary bleeding or coagulopathy

Primary outcomes:
measure: progression free survival (PFS)
timeFrame: 4 years
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: 4 years
measure: Treatment-related toxicity
timeFrame: 4 years
Other outcomes:
Locations:
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
state: Sichuan
Study officials:
affiliation: Afﬁliated Hospital of North Sichuan Medical College
name: Daiyuan Ma, M.D
role: PRINCIPAL_INVESTIGATOR
References: