Concurrent Endostar, Paclitaxel/Carboplatin and Radiotherapy for Locally Advanced Non-small Cell Lung (RT0902)

NCT ID: NCT01158144

Last Updated: 2010-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2013-12-31

Brief 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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endostar

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.

Group Type: EXPERIMENTAL

Endostar

Intervention Type: DRUG

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.

Conctrol

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.

Group Type: ACTIVE_COMPARATOR

Paclitaxel/Carboplatin

Intervention Type: DRUG

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.

Interventions

Endostar

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.

Intervention Type: DRUG

Paclitaxel/Carboplatin

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.

Intervention Type: DRUG

Other Intervention Names

Recombinant Human Endostatin; PC

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhejiang Cancer Hospital

Principal Investigators

Shenglin Ma, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shenglin Ma, MD

Role: CONTACT

mashenglin@medmail.com.cn

+8657188122568

Yaping Xu, MD

Role: CONTACT

xuyaping1207@gmail.com

+8657188122082

Facility Contacts

Shenglin Ma, MD

Role: primary

mashenglin@medmail.com.cn

+8657188122568

Yaping Xu, MD

Role: backup

xuyaping1207@gmail.com

+8657188122082

Xu Ya ping, MD

Role: primary

xuyaping1207@gmail.com

0086-571-88122082

References

Sun XJ, Deng QH, Yu XM, Ji YL, Zheng YD, Jiang H, Xu YP, Ma SL. A phase II study of Endostatin in combination with paclitaxel, carboplatin, and radiotherapy in patients with unresectable locally advanced non-small cell lung cancer. BMC Cancer. 2016 Apr 11;16:266. doi: 10.1186/s12885-016-2234-0.

Reference Type: DERIVED

PMID: 27067521 (View on PubMed)

Other Identifiers

ZhejiangCH03

Identifier Type: -

Identifier Source: org_study_id