A Randomized Contrasted Polycentric Clinical Study About Chemotherapy Combined With Whole-body Hyperthermia(WBH)to Treat Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)
Inclusion Criteria:
1. Older than 18, survive more than 3 months;
2. Pathologically or cytologically proven stage IIIB/IV non small cell lung
cancer(NSCLC);
3. Measurable disease, defined as lesions that can be accurately measured in at least
one dimension (longest diameter to be recorded) as ≥ 2 cm with conventional
techniques or as ≥ 1 cm with spiral CT scan No known CNS tumors, including brain
metastases;
4. ECOG performance status 0-2;
5. Granulocytes ≥ 1,500/μL Platelets ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Bilirubin ≤ 3
mg/dL ALT and AST ≤ 2 times upper limit of normal (ULN) PT/INR ≤ 1.7 (therapeutic
anticoagulation [e.g., coumadin or heparin] allowed provided there is no prior
evidence of underlying abnormality in these parameters) Creatinine ≤ 1.5 times ULN OR
creatinine clearance ≥ 60 mL/min;
6. Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception before, during, and for 30 days after completion of study therapy;
7. Other prior adjuvant therapy is allowed provided it was completed > 6 months ago AND
there is documented recurrence of NSCLC;
8. No prior local therapy for the target lesion unless the target lesion located within
the field of local therapy has shown ≥ 25% increase in size since last treatment;
9. At least 4 weeks since prior and no concurrent palliative radiotherapy No concurrent
combination anti-retroviral therapy for HIV;
10. volunteers who signed informed consent.
Exclusion Criteria:
1. During Screening period and treatment period, the main target for lesions has been
given radiation;
2. The body has metal material, including a metal JieYuHuan/support/operation fixed
material within;
3. Existing cerebrovascular diseases and central nervous system tumors, including
metastatic carcinoma;
4. Patients with recent or ongoing gastrointestinal bleed may not be transfused to reach
the entry hemoglobin of 8.5 g/dL Physicians should ensure patients requiring
transfusion prior to registration do not have an occult or clinically apparent
gastrointestinal bleed No history of bleeding diathesis;
5. No significant history of cardiac disease, including any of the following: NYHA class
III-IV congestive heart failure Myocardial infarction within the past 6 months
Cardiac arrhythmias requiring anti-arrhythmic therapy (other than beta blockers or
digoxin) LVEF < 45% (or below the normal limit at the individual institution) by
scintigraphy (MUGA or myocardial scintigram) History of hypertension allowed provided
it is well controlled (i.e., BP < 140/90 mm Hg) on a regimen of anti-hypertensive
therapy
6. Other prior adjuvant therapy is allowed provided it was completed > 6 months ago AND
there is documented recurrence of NSCLC
7. No prior systemic therapy for metastatic disease At least 4 weeks since prior
locoregional therapy (e.g., embolization, chemoembolization [except with doxorubicin
hydrochloride], radiotherapy, or radioactive microspheres)
8. No prior local therapy for the target lesion unless the target lesion located within
the field of local therapy has shown ≥ 25% increase in size since last treatment
9. poor Compliance, not receiving medication or follow-up according to study plan;
10. There are other serious situations contrary to the scheme
11. Existing tuberculosis;
12. Exist two or multiple tumors