Status:
UNKNOWN
Chemotherapy Combined With Whole-body Hyperthermia to Treat Stage IIIB/IV Non Small Cell Lung Cancer
Lead Sponsor:
Xijing Hospital
Conditions:
Non-small Cell Lung Cancer Stage IIIB
Toxicity Due to Chemotherapy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Millions of patients die of non-small cell lung cancer (NSCLC) every year. There are several methods to treat NSCLC, including surgery, chemotherapy, radiotherapy and bioimmuotherapy. Recently, hypert...
Eligibility Criteria
Inclusion
- Older than 18, survive more than 3 months;
- Pathologically or cytologically proven stage IIIB/IV non small cell lung cancer(NSCLC);
- 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;
- ECOG performance status 0-2;
- 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;
- Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception before, during, and for 30 days after completion of study therapy;
- Other prior adjuvant therapy is allowed provided it was completed \> 6 months ago AND there is documented recurrence of NSCLC;
- 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;
- At least 4 weeks since prior and no concurrent palliative radiotherapy No concurrent combination anti-retroviral therapy for HIV;
- volunteers who signed informed consent.
Exclusion
- During Screening period and treatment period, the main target for lesions has been given radiation;
- The body has metal material, including a metal JieYuHuan/support/operation fixed material within;
- Existing cerebrovascular diseases and central nervous system tumors, including metastatic carcinoma;
- 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;
- 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
- Other prior adjuvant therapy is allowed provided it was completed \> 6 months ago AND there is documented recurrence of NSCLC
- 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)
- 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
- poor Compliance, not receiving medication or follow-up according to study plan;
- There are other serious situations contrary to the scheme
- Existing tuberculosis;
- Exist two or multiple tumors
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01493011
Start Date
November 1 2011
End Date
December 1 2015
Last Update
May 15 2012
Active Locations (1)
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1
Xijing Hospital
Xi’an, Shanxi, China, 710031