Chemotherapy Combined With Whole-body Hyperthermia to Treat Stage IIIB/IV Non Small Cell Lung Cancer

Non-small Cell Lung Cancer Stage IIIB Clinical Trial

— WBH&NSCLC  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01493011
• Other study ID #: FMMU
• Status: Recruiting
• Phase: N/A
• First received: December 7, 2011
• Last updated: May 13, 2012
• Start date: November 2011
• Est. completion date: December 2015

Study information

• Verified date: May 2012
• Source: Xijing Hospital
• Contact: LIU WENCHAO, professor
• Phone: 029-84775407
• Email: liuch[@]FMMU.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Device:
• chemotherapy & WBH
standard first-line chemotherapy combined with whole-body hyperthemia to treat stage ?b/? NSCLC

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		one year	No
Secondary	Toxicity as assessed by NCI CTC v3.0		one year	Yes
Secondary	overall suivival		one year	No
Secondary	quality of life		one year	Yes
Secondary	Disease Control Rate		one year	No