Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin for Local Advanced Non-small Cell Lung Cancer (NSCLC)
NCT ID: NCT01211002
Last Updated: 2010-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
170 participants
INTERVENTIONAL
2010-10-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
OTHER
Simcere Pharmaceutical Co., Ltd
OTHER
Responsible Party
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Daping Hospital and Research Institute of Surgery of Third Military Medical University
Principal Investigators
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zhenzhou yang, M.D.
Role: STUDY_CHAIR
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Locations
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Daping Hospital
Chongqin, , China
Countries
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Central Contacts
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Facility Contacts
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zhenzhou yang, M.D.
Role: primary
Other Identifiers
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sim201002
Identifier Type: -
Identifier Source: org_study_id