Non-Small Cell Lung Cancer
Conditions
Keywords
Overall survival
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.
Interventions
OTHERChemoradiotherapy Regimen between PC and PE
etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 during radiotherapy paclitaxel 45mg/m2 weekly and carbplatin AUC =2mg/mL/min weekly during radiotherapy
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival | 2 years |
Outcome results
None listed