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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)


N/A
18 Years
75 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer Stage IIIB, Toxicity Due to Chemotherapy

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Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

LIU WENCHAO, PROFESSOR

Investigator Role:

Study Chair

Investigator Affiliation:

xijing hospital of the fourth military medical univercity

Authority:

China: Food and Drug Administration

Study ID:

FMMU

NCT ID:

NCT01493011

Start Date:

November 2011

Completion Date:

December 2015

Related Keywords:

  • Non-small Cell Lung Cancer Stage IIIB
  • Toxicity Due to Chemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Fever
  • Lung Neoplasms

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