Chemotherapy Combined With Whole-body Hyperthermia to Treat Stage IIIB/IV Non Small Cell Lung Cancer (WBH&NSCLC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Xijing Hospital
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01493011
First received: December 7, 2011
Last updated: May 13, 2012
Last verified: May 2012

December 7, 2011
May 13, 2012
November 2011
December 2012   (final data collection date for primary outcome measure)
Progression-free survival (PFS) [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01493011 on ClinicalTrials.gov Archive Site
  • Toxicity as assessed by NCI CTC v3.0 [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • overall suivival [ Time Frame: one year ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Disease Control Rate [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Chemotherapy Combined With Whole-body Hyperthermia to Treat Stage IIIB/IV Non Small Cell Lung Cancer
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)

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, hyperthermia therapy has played an important role in neoplasm therapy. It has showed some effect in NSCLC both in animal experiment and clinical practice, yet there is little literature about Whole-body Hyperthermia (WBH) with neoplasm. The investigators decides to develop this randomized contrasted multicenter clinical study to testify to the effect of chemotherapy combined with WBH to treat stage IIIB/IV Non Small Cell Lung Cancer (NSCLC).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Non-small Cell Lung Cancer Stage IIIB
  • Toxicity Due to Chemotherapy
Device: chemotherapy & WBH
standard first-line chemotherapy combined with whole-body hyperthemia to treat stage Ⅲb/Ⅳ NSCLC
  • Experimental: chemotherapy & WBH
    Standard chemotherapy protocol combined with whole body hyperthermia
    Intervention: Device: chemotherapy & WBH
  • No Intervention: chemotherapy
    standard chemotherapy protocol for advanced NSCLC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2015
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: LIU WENCHAO, professor 029-84775407 liuch@FMMU.edu.cn
China
 
NCT01493011
FMMU
Yes
Xijing Hospital
Xijing Hospital
Not Provided
Study Chair: LIU WENCHAO, PROFESSOR xijing hospital of the fourth military medical univercity
Xijing Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP