Non Small Cell Lung Cancer
Conditions
Interventions
Group A:Whole-body Hyperthermia
group B:standard chemotherapy
Sponsors
Oncology Center, Xijing Hospital, the Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
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/uL Platelets >=75,000/uL Hemoglobin >=8.5 g/dL Bilirubin =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
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 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 stituations contrary to the scheme; 11. Existing tuberculosis; 12. Exist two or multiple tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;QoL;DCR;safety; | — |
Countries
China
Contacts
Public ContactWenchao Liu
Outcome results
None listed