Endostar in Combination With Chemoradiotherapy in Patient With Advanced Non-small Cell Lung Cancer

Quality of Life Clinical Trial

Official title:

Recombinant Human Endostatin (Endostar) Combined With Concurrent Chemoradiotherapy for Advanced Non-small Cell Lung Cancer: A Multicenter, Randomized, Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03588494
• Other study ID #: NSOG001
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: August 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: June 2018
• Source: Af?liated Hospital of North Sichuan Medical College
• Contact: Daiyuan Ma, M.D
• Phone: 868172246171
• Email: angenpn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 318
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Quality of Life

Intervention

Combination Product:
• concurrent chemoradiotherapy (CCRT)
Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1~5 and 29~33. Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday~Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.

Drug:
• Endostar for one cycle
Endostar(15mg/m2) was durative transfused during the normalization window of the first chemoradiotherapy cycle(days -5~-1).
• Endostar for two cycles
Endostar(15mg/m2) was durative transfused during the normalization window of the first and the second chemoradiotherapy cycles(days -5~-1 and 24~28).

Locations

Country	Name	City	State
China	Affiliated Hospital of North Sichuan Medical College	Nanchong	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Af?liated Hospital of North Sichuan Medical College	Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival (PFS)	Evaluate the effect of chemoradiotherapy with or without recombinant human endostatin on progression free survival	4 years
Secondary	Overall Survival(OS)	comparison to maintenance chemoradiotherapy alone	4 years
Secondary	Treatment-related toxicity	Toxicity and adverse events related to the inventions	4 years