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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01493011
Recruitment Status : Unknown
Verified May 2012 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : December 15, 2011
Last Update Posted : May 15, 2012
Information provided by (Responsible Party):
Xijing Hospital

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, 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).

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Stage IIIB Toxicity Due to Chemotherapy Device: chemotherapy & WBH Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : November 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: chemotherapy & WBH
Standard chemotherapy protocol combined with whole body hyperthermia
Device: chemotherapy & WBH
standard first-line chemotherapy combined with whole-body hyperthemia to treat stage Ⅲb/Ⅳ NSCLC
No Intervention: chemotherapy
standard chemotherapy protocol for advanced NSCLC

Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Toxicity as assessed by NCI CTC v3.0 [ Time Frame: one year ]
  2. overall suivival [ Time Frame: one year ]
  3. quality of life [ Time Frame: one year ]
  4. Disease Control Rate [ Time Frame: one year ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01493011

Contact: LIU WENCHAO, professor 029-84775407

China, Shanxi
Xijing Hospital Recruiting
Xi'an, Shanxi, China, 710031
Contact: GUO JUNZHAO, DOCTOR    029-84775412   
Sponsors and Collaborators
Xijing Hospital
Study Chair: LIU WENCHAO, PROFESSOR xijing hospital of the fourth military medical univercity

Responsible Party: Xijing Hospital Identifier: NCT01493011     History of Changes
Other Study ID Numbers: FMMU
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Body Temperature Changes
Signs and Symptoms