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

NCT03588494 | Unknown Phase 2

• 1 other identifier: NSOG001
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

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).

Conditions

Quality of Life

Keywords

Recombinant human endostatin; NSCLC; chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• progression free survival (PFS)

  Evaluate the effect of chemoradiotherapy with or without recombinant human endostatin on progression free survival

  4 years

Secondary Outcomes (2)

• Overall Survival(OS)

  4 years

• Treatment-related toxicity

  4 years

Study Arms (3)

concurrent chemoradiotherapy (CCRT)

ACTIVE COMPARATOR

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.

Combination Product: concurrent chemoradiotherapy (CCRT)

W1-CCRT

EXPERIMENTAL

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.

Combination Product: concurrent chemoradiotherapy (CCRT); Drug: Endostar for one cycle

W2-CCRT

EXPERIMENTAL

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.

Combination Product: concurrent chemoradiotherapy (CCRT); Drug: Endostar for two cycles

Interventions

concurrent chemoradiotherapy (CCRT) COMBINATION_PRODUCT

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; W2-CCRT; concurrent chemoradiotherapy (CCRT)

Endostar for one cycle DRUG

Endostar(15mg/m2) was durative transfused during the normalization window of the first chemoradiotherapy cycle(days -5～-1).

W1-CCRT

Endostar for two cycles DRUG

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

W2-CCRT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female patients, age: 18-70 years of age
• \. 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.
• \. No previous chest radiotherapy and radiotherapy, immunotherapy or biological therapy.
• \. Eastern Cooperative Oncology Group (ECOG) test scored 0-1.
• \. Serum hemoglobin ≥ 100g/L, platelet ≥ 100 × 109/L, absolute number of neutrophils ≥ 1.5 × 109/L.
• \. Serum creatinine ≤ 1.25 times the upper limit of normal(UNL) or creatinine clearance ≥ 60 mL/min.
• \. Serum bilirubin ≤ 1.5 times UNL, Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL.
• \. Forced vital capacity rate of one second（FEV1）\>0.8 litre.
• \. Coagulation function is normal
• \. lesions are measurable according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST1.1)standard
• \. Sign the inform consent form with good compliance

You may not qualify if:

• \. Carcinoid or small cell lung cancer
• \. Patients with any distant metastasis
• \. patients with previous or current malignancy, except for skin non-melanoma or carcinoma in situ in the cervix
• \. 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).
• \. Pregnancy or breastfeeding women
• \. Women who may be pregnant but are unwilling to take appropriate contraception
• \. Hereditary bleeding or coagulopathy

Sponsors & Collaborators

• Affiliated Hospital of North Sichuan Medical College: lead
• Jiangsu Simcere Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, 600000, China

Location

MeSH Terms

Interventions

Chemoradiotherapy; endostar protein

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Daiyuan Ma, M.D

  Affiliated Hospital of North Sichuan Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daiyuan Ma, M.D

CONTACT

868172246171; angenpn@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Center

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2018
• First Posted: July 17, 2018
• Study Start: August 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2021
• Last Updated: July 17, 2018

Record last verified: 2018-06

Locations

CN (1)