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Trial Title:
Concurrent Endostar, Paclitaxel/Carboplatin and Radiotherapy for Locally Advanced Non-small Cell Lung (RT0902)
NCT ID:
NCT01158144
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Carboplatin
Endostar protein
Endostatins
Conditions: Keywords:
Non-small cell lung cancer
Locally advanced
Radiotherapy
Concomitant Chemotherapy
Endostar
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Endostar
Description:
Patients with non-resectable non-small Cell Lung Cancer will receive thoracic radiation
therapy 60-66 Gy over 30-33 fractions and concurrent with Endostar 7.5 mg/m2 over 3 hours
d1-14, Paclitaxel 50 mg/m2 weekly over 1 hour, Carboplatin AUC = 2 mg/mL/min over 30 min
weekly. Followed by Endostar 7.5 mg/m2 d1-14,Paclitaxel 175 mg/m2 d1 and Carboplatin AUC
= 5 mg/mL/min d1 every 3 weeks for 2 cycles as consolidation treatment.
Arm group label:
Endostar
Other name:
Recombinant Human Endostatin
Intervention type:
Drug
Intervention name:
Paclitaxel/Carboplatin
Description:
Patients with non-resectable non-small Cell Lung Cancer will receive thoracic radiation
therapy 60-66 Gy over 30-33 fractions and concurrent with Paclitaxel 50 mg/m2 weekly over
1 hour, Carboplatin AUC = 2 mg/mL/min over 30 min weekly. Followed by Paclitaxel 175
mg/m2 d1 and Carboplatin AUC = 5 mg/mL/min d1 every 3 weeks for 2 cycles as consolidation
treatment.
Arm group label:
Conctrol
Other name:
PC
Summary:
Concomitant chemoradiotherapy is the standard treatment of locally advanced,
non-resectable, non-small cell lung cancer (NSCLC). However, the optimal chemotherapy
regimen is still controversial. The purpose of this study was to evaluate the efficacy
and toxicity of a concomitant treatment using Endostar (Recombinant Human Endostatin),
Paclitaxel/Carboplatin and radiotherapy for LA-NSCLC, and also assess its impact on
patient Quality of Life (QoL) and progression-free survival (PFS).
Detailed description:
Patients with non-resectable non-small Cell Lung Cancer will receive thoracic radiation
therapy 60-66 Gy over 30-33 fractions and concurrent with Endostar 7.5 mg/m2 over 3 hours
d1-14, Paclitaxel 50 mg/m2 weekly over 1 hour, Carboplatin AUC = 2 mg/mL/min over 30 min
weekly. Followed by Endostar 7.5 mg/m2 d1-14,Paclitaxel 175 mg/m2 d1 and Carboplatin AUC
= 5 mg/mL/min d1 every 3 weeks for 2 cycles as consolidation treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically proven non-small cell lung cancer (squamous cell carcinoma,
adenocarcinoma, large cell carcinoma and etc)
- Presence of measurable disease by RECIST
- stage IIIA or IIIB, non-resectable
- ECOG performance status 0-1
- No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic
therapy .Patients must sign an informed consent indicating that they are aware of
the .investigational nature of the study in keeping with the policy of the hospital.
Exclusion Criteria:
- Carcinoid tumor, small cell carcinoma of lung
- Patients with any distant metastasis
- History of another malignancy except cured basal cell carcinoma of skin and cured
carcinoma in-situ of uterine cervix
- Any other morbidity or situation with contraindication for radiotherapy (e.g. active
infection, myocardial infarction preceding 6 months, symptomatic heart disease
including unstable angina, congestive heart failure or uncontrolled arrhythmias,
immunosuppressive treatment)
- Pregnant or lactating women, women who has not taken test of pregnancy (within 7
days before the first administration) and pregnant women
- Women and men of childbearing potential who have no willing of employing adequate
contraception Tumor EGFR wild
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Shenglin Ma, MD
Phone:
+8657188122568
Email:
mashenglin@medmail.com.cn
Contact backup:
Last name:
Yaping Xu, MD
Phone:
+8657188122082
Email:
xuyaping1207@gmail.com
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Ya ping, MD
Phone:
0086-571-88122082
Email:
xuyaping1207@gmail.com
Start date:
October 2009
Completion date:
December 2013
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01158144
