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Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin for Local Advanced Non-small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT01211002
Recruitment Status : Unknown
Verified September 2010 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was:  Not yet recruiting
First Posted : September 29, 2010
Last Update Posted : September 29, 2010
Sponsor:
Collaborator:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Information provided by:
Simcere Pharmaceutical Co., Ltd

Brief Summary:
It is a trials to evaluate the overall survival (OS) of radiotherapy / EP combined with recombinant human endostatin in treatment of locally advanced (Ⅲ A / unresectable Ⅲ B) non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Radiation: radiotherapy combined with EP Drug: radiotherapy / EP combined with recombinant human endostatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Exploratory Clinical Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin (Endostar) for Local Advanced Non-small Cell Lung Cancer (NSCLC (Ⅲ A / Ⅲ B) )
Study Start Date : October 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: radiotherapy combined with EP
the dose of radiotherapy is 60-66 Gy / 30-33f.The combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses.
Radiation: radiotherapy combined with EP
Tumor vo lume is 60-66 Gy / 30-33f and the combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses.

Experimental: adiotherapy / EP /recombinant human endostatin
recombinant human endostatin: The number of courses is 3 ~ 4 and each course last for 28 days.dose:15mg,d1-14, intravenous injection.
Drug: radiotherapy / EP combined with recombinant human endostatin
Anti-vascular targeting therapy The number of courses is 3 ~ 4 and each course last for 28 days. Recombinant human endostatin(Endostar):15mg,d1-14, intravenous injection.




Primary Outcome Measures :
  1. overall survival (OS) [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. quality of life [ Time Frame: 2 years ]
  2. objective response rate (ORR) [ Time Frame: 1 years ]
  3. disease control rate (DCR) [ Time Frame: 1 year ]
  4. progression-free survival (PFS) [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with pathologically or histologically confirmed and inoperable stage Ⅲ (Ⅲ A or unresectable Ⅲ B) NSCLC;
  2. Patients with ages of 18~70 years, general condition ECOG performance scale (PS)≤ 1, weight loss <10% during last 6 months;
  3. CT films of patients during last 4 weeks were accessible when patients were selected into the groups, the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, PET-CT, with the largest diameter≥ 20mm by ordinary CT and MRI.)
  4. No major organ dysfunction, the function of heart, liver and kidney was normal, laboratory indicators should meet the following requirements: Blood: WBC> 4.0 × 109 / L, absolute neutrophil count > 1.5 × 109 / L, platelet count> 100 × 109 / L, hemoglobin> 110g / L; liver function: serum bilirubin was less than 1.5 × maximum normal value ; ALT and AST were less than 1.5 × maximum normal value; BUN, Cr within the normal range; FEV1 > 1L or> 40% of predicted value;
  5. Patients could understand the circumstances of this study and those who have signed the informed consent form;

Exclusion Criteria:

  1. Pregnant or lactating women; women of child-bearing age without contraception;
  2. Acute infection or other serious underlying diseases;
  3. Significant neurological, psychiatric history, including dementia which may influence the ability to understand and the informed consent;
  4. Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs a the same time; have joined other drug clinical trials 30 days before this clinical trial;
  5. Diabetes without control (blood-glucose is unstable or ≥ 8mol / L after administration);
  6. Patients who are allergic to E. coli preparation;
  7. Patients who are unsuitable to participate in this trial determined by the researchers.

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): NCT01211002


Contacts
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Contact: Zhenzhou Yang, M.D. yangzhenzhou@sohu.com

Locations
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China
Daping Hospital Not yet recruiting
Chongqin, China
Contact: zhenzhou yang, M.D.       yangzhenzhou@sohu.com   
Principal Investigator: zhenzhou yang, M.D.         
Sponsors and Collaborators
Simcere Pharmaceutical Co., Ltd
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Investigators
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Study Chair: zhenzhou yang, M.D. Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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Responsible Party: Zhenzhou Yang M.D., Daping Hospital and Research Institute of Surgery of Third Military Medical University
ClinicalTrials.gov Identifier: NCT01211002     History of Changes
Other Study ID Numbers: sim201002
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: September 29, 2010
Last Verified: September 2010

Keywords provided by Simcere Pharmaceutical Co., Ltd:
Radiotherapy
rh-endostatin
chemotherapy
NSCLC

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Endostatins
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors