Non-small-cell Lung Cancer
Conditions
Keywords
Nimotuzumab, Chemoradiotherapy,Squamous Cell Lung Cancer
Brief summary
This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.
Detailed description
This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab combined with chemoradiotherapy for unresectable,locally advanced squamous cell lung cancer. All patients were planned to receive radical dose of chest radiation and concurrent chemotherapy of weekly docetaxel and cisplatin, each of 1 day's duration. Nimotuzumab group was treated with weekly nimotuzumab (200mg, IV) combined with chemoradiotherapy, while control group was treated with chemoradiotherapy.
Interventions
DRUGNimotuzumab
Patients received weekly nimotuzumab (200mg, IV) concurrent with chemoradiotherapy.
Patients received weekly docetaxel and cisplatin, each of 1 day's duration,concurrent with chest radiotherapy
RADIATIONdaily RT to the chest
Patients received daily RT to the chest
Sponsors
Sun Yat-sen University
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
* histologically confirmed squamous cell lung cancer * patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria * unresectable phase IIIA(N2) and IIIB lung cancer confirmed by CT or MRI * ECOG performance status 0-1 * Previously treated with chemotherapy or treatment-naive * no previous chest radiotherapy, immunotherapy or biotherapy. * hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL * serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min * bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL * FEV1 \>0.8 L * CB6 within normal limits * patients and their family signed the informed consents
Exclusion criteria
* adenosquamous carcinoma * previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ * contraindication for chemotherapy * women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose * women who has the probability of pregnancy without contraception * tendency of hemorrhage * in other clinical trials within 30 days * addicted in drugs or alcohol, AIDS patients * uncontrollable seizure or psychotic patients without self-control ability * severe allergy or idiosyncrasy * not suitable for this study judged by researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 3 years | — |
| progression-free survival | 3 years | — |
| rate of grade 3-4 radiation esophagitis | 1 years | rate of grade 3-4 radiation esophagitis as assessed by CTCAE v4.0 |
| rate of grade 3-4 radiation pneumonitis | 1 year | rate of grade 3-4 radiation pneumonitis as assessed by CTCAE v4.0 |
| Failure patterns | 3 years | rates of local-regional recurrence, distant metastasis and brain metastasis |
Countries
China
Outcome results
None listed