A Prospective Randomized Phase Ⅱ Study of Nimotuzumab Combined With Chemoradiotherapy for Unresectable, Locally Advanced Squamous Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Nimotuzumab
- Conditions
- Non-small-cell Lung Cancer
- Sponsor
- Sun Yat-sen University
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- overall survival
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Hui Liu
Professor
Sun Yat-sen University
Eligibility Criteria
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
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
Arms & Interventions
Nimotuzumab
Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin, and concurrent weekly Nimotuzumab.
Intervention: Nimotuzumab
Nimotuzumab
Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin, and concurrent weekly Nimotuzumab.
Intervention: docetaxel and cisplatin
Nimotuzumab
Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin, and concurrent weekly Nimotuzumab.
Intervention: daily RT to the chest
Control
Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin.
Intervention: docetaxel and cisplatin
Control
Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin.
Intervention: daily RT to the chest
Outcomes
Primary Outcomes
overall survival
Time Frame: 3 years
Secondary Outcomes
- progression-free survival(3 years)
- rate of grade 3-4 radiation esophagitis(1 years)
- Objective Response Rate(3 years)
- Failure patterns(3 years)
- rate of grade 3-4 radiation pneumonitis(1 year)