Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: Split-course Chemoradiotherapy for Local Advanced NSCLC With Impaired Baseline Pulmonary Function

Summary: This Phase II randomized study is to determine the efficacy of split-course chemoradiotherapy for local advanced non-small cell lung cancer with severe impairment of baseline pulmonary function.

Detailed description: This Phase II randomized study is to determine the efficacy of split-course chemoradiotherapy for local advanced non-small cell lung cancer with severe impairment of baseline pulmonary function.
  Patients received four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, concurrent with split-course thoracic radiotherapy of 40 Gy/10 fractions and 28 Gy/7 fractions administered in the first and second courses, respectively, with one-month break. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date at which disease progresses. Progression-free survival will be calculated 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.
  -  Moderate to severe obstructive ventilatory dysfunction (FEV1.0/FVC≤60%), or / and moderate to severe restrictive ventilatory dysfunction(FEV1.0/FVC≤60%，TLC-SB（Act1/Pred）≤80%), or / and moderate to severe diffusion dysfunction (DLCOc/VA（Act1/Pred）≤60%).
  -  Imbalance of pulmonary perfusion (less than 36% on the left, or less than 44% on the right).
  -  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