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

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ClinicalTrials.gov Identifier: NCT03588494
Recruitment Status : Unknown
Verified June 2018 by DaiYuan Ma, Affiliated Hospital of North Sichuan Medical College.
Recruitment status was:  Not yet recruiting
First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
DaiYuan Ma, Affiliated Hospital of North Sichuan Medical College

Study Description
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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).

Condition or disease Intervention/treatment Phase
Quality of Life Combination Product: concurrent chemoradiotherapy (CCRT) Drug: Endostar for one cycle Drug: Endostar for two cycles Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Recombinant Human Endostatin (Endostar) Combined With Concurrent Chemoradiotherapy for Advanced Non-small Cell Lung Cancer: A Multicenter, Randomized, Controlled Trial
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2021

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.

 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.
Experimental: W1-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.

 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).
Experimental: W2-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.

 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 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).


Outcome Measures
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Primary Outcome Measures :
  1. progression free survival (PFS) [ Time Frame: 4 years ]
    Evaluate the effect of chemoradiotherapy with or without recombinant human endostatin on progression free survival


Secondary Outcome Measures :
  1. Overall Survival(OS) [ Time Frame: 4 years ]
    comparison to maintenance chemoradiotherapy alone

  2. Treatment-related toxicity [ Time Frame: 4 years ]
    Toxicity and adverse events related to the inventions


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588494


Contacts
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Contact: Daiyuan Ma, M.D 868172246171 angenpn@gmail.com

Locations
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China, Sichuan
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China, 600000
Contact: Daiyuan Ma, M.D    868172246171    angenpn@gmail.com   
Principal Investigator: xin hu, M.D         
Principal Investigator: xiangdong fang, M.D         
Sponsors and Collaborators
Affiliated Hospital of North Sichuan Medical College
Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Daiyuan Ma, M.D Affiliated Hospital of North Sichuan Medical College
More Information
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Responsible Party: DaiYuan Ma, Director of Cancer Center, Affiliated Hospital of North Sichuan Medical College
ClinicalTrials.gov Identifier: NCT03588494    
Other Study ID Numbers: NSOG001
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DaiYuan Ma, Affiliated Hospital of North Sichuan Medical College:
Recombinant human endostatin
NSCLC
chemoradiotherapy
Additional relevant MeSH terms:
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Endostar protein
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
 Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents