Study of Etoposide, Cisplatin, and Radiotherapy Versus Paclitaxel, Carboplatin and Radiotherapy to Treat Non-Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Other: Chemoradiotherapy Regimen between PC and PE

• Registration Number: NCT01494558
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

Cisplatin-based combination chemotherapy given concurrently with radiotherapy is the standard of care for patients with inoperable stage III NSCLC. The most common chemotherapeutic agents used concurrently with radiotherapy have been vinorelbine, vinblastine, and etoposide in conjunction with cisplatin or weekly paclitaxel and carboplatin. No randomized phase III trials of concurrent chemoradiotherapy have shown the superiority of one chemotherapy regimen over another. The clinical trial is to compare radiotherapy concurrently with PE (etoposide and cisplatin) and PC (paclitaxel and carbplatin) for local advanced NSCLC (stage IIIA/IIIB). It is a randomized, multicenter, open labeled phase III clinical trial. All patients receive conformal radiotherapy or intensity modulated radiotherapy with conventional fraction. The chemotherapy regimens are PE (etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 ) and PC (paclitaxel 45mg/m2 weekly over 1hour and carbplatin AUC =2mg/mL/min over 30min weekly). The primary purpose is to evaluate objective response rate, complications, progression-free survival, overall survival. The second purpose is to evaluate quality of life and cost.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2010-10
• Study Completion: 2011-08
• Status Verified: 2011-12
• Study First Submitted: 2011-12-14
• Study First Submitted QC: 2011-12-16
• Last Update Submitted: 2011-12-16
• Study First Posted: 2011-12-19
• Last Update Posted: 2011-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Inoperable stage IIIA/IIIB NSCLC proved by pathology or cytology
2. Age 18 to 75, ECOG ≤ 2, lose weight <10% during 6 months
3. No serious diseases of important organs
4. Chest CT in recently 4 weeks
5. No other tumor disease except stage I cervical cancer or cutaneous basal cell carcinoma
6. Sign consent
7. Measurable lesion

Exclusion Criteria

1. Pretreatment radiotherapy or chemotherapy
2. Pregnant or lactation woman
3. Serious diseases (include uncontrolled diabetes and infection) of important organs
4. Psychopath
5. Join in other clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PE concurrent chemotherapy	Chemoradiotherapy Regimen between PC and PE	Radiotherapy concurrently with PE chemotherapy
PC concurrent chemotherapy	Chemoradiotherapy Regimen between PC and PE	Radiotherapy concurrently with PC chemotherapy

Primary Outcome Measures

Name	Time	Method
Overall Survival	2 years

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	2 years