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

Phase 2

• Conditions: Quality of Life
• Interventions: Combination Product: concurrent chemoradiotherapy (CCRT); Drug: Endostar for one cycle; Drug: Endostar for two cycles

• Registration Number: NCT03588494
• Lead Sponsor: Affiliated Hospital of North Sichuan Medical College

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-23
• Study First Submitted QC: 2018-07-04
• Last Update Submitted: 2018-07-04
• Study First Posted: 2018-07-17
• Last Update Posted: 2018-07-17
• Study Start: 2018-08-01
• Primary Completion: 2019-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 318

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
W1-CCRT	Endostar for one cycle	Endostar(15 mg/m2) was durative transfused every 24 hours for 5 days during the normalization window of the first chemoradiotherapy cycle(days -5～-1). 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.
W2-CCRT	Endostar for two cycles	Endostar(15 mg/m2) was durative transfused every 24 hours for 5 days during the normalization window of the first and the second chemoradiotherapy cycles(days -5～-1 and 24～28). 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.
concurrent chemoradiotherapy (CCRT)	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.
W1-CCRT	concurrent chemoradiotherapy (CCRT)	Endostar(15 mg/m2) was durative transfused every 24 hours for 5 days during the normalization window of the first chemoradiotherapy cycle(days -5～-1). 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.
W2-CCRT	concurrent chemoradiotherapy (CCRT)	Endostar(15 mg/m2) was durative transfused every 24 hours for 5 days during the normalization window of the first and the second chemoradiotherapy cycles(days -5～-1 and 24～28). 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.

Primary Outcome Measures

Name	Time	Method
progression free survival (PFS)	4 years	Evaluate the effect of chemoradiotherapy with or without recombinant human endostatin on progression free survival

Secondary Outcome Measures

Name	Time	Method
Overall Survival(OS)	4 years	comparison to maintenance chemoradiotherapy alone
Treatment-related toxicity	4 years	Toxicity and adverse events related to the inventions

Trial Locations

Locations (1)

Affiliated Hospital of North Sichuan Medical College; 🇨🇳 Nanchong, Sichuan, China