Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Study of Consolidation Chemotherapy For Bulky Local Advanced None-small Cell Lung Cancer

Summary: This Phase II randomized study is to determine the efficacy of consolidation chemotherapy after split irradiation with concurrent chemotherapy in locally advanced none-small cell lung cancer patients with bulky tumor.

Detailed description: This Phase II randomized study is to determine the efficacy of consolidation chemotherapy(CC) after split-course chemoradiotherapy(CCRT) in locally advanced non-small cell lung cancer with bulky tumor.
  Patients were randomly assigned to either CCRT alone (observation arm) or CCRT followed by CC (consolidation arm). All patients received four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, combined with split-course thoracic radiotherapy of 51 Gy/17 fractions and 15 Gy/5 fractions administered in the first and second courses, respectively, with one-month break. In the consolidation arm, patients were further treated with two cycles of pemetrexed(500mg/㎡) in non-squamous lung cancer or docetaxel(60mg/㎡) in squamous lung cancer, each of 3 days' duration, every 3 weeks. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date on which disease progresses. Progression-free survival will be calculated and compared using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 4.0.

Eligibility: Inclusion Criteria:
  -  Pathologic confirmation of NSCLC.
  -  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 PET/CT, CT or MRI.
  -  Whole lung V20>=35% when giving 60Gy which is the minimum dose of radical irradiation.
  -  Eastern Cooperative Oncology Group (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:
  -  Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ
  -  Contraindication for chemotherapy
  -  Malignant pleural or pericardial effusion.
  -  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

Relevance to patient case: not relevant