Chemotherapy Combined With Whole-body Hyperthermia to Treat Stage IIIB/IV Non Small Cell Lung Cancer (WBH&NSCLC)
This study is currently recruiting participants.
Verified May 2012 by Xijing Hospital
Sponsor:
Xijing Hospital
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
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Purpose
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 | Intervention |
|---|---|
|
Non-small Cell Lung Cancer Stage IIIB Toxicity Due to Chemotherapy |
Device: chemotherapy & WBH |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (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) |
Resource links provided by NLM:
Further study details as provided by Xijing Hospital:
Primary Outcome Measures:
- Progression-free survival (PFS) [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493011
Contacts
| Contact: LIU WENCHAO, professor | 029-84775407 | liuch@FMMU.edu.cn |
Locations
| China, Shanxi | |
| Xijing Hospital | Recruiting |
| Xi'an, Shanxi, China, 710031 | |
| Contact: GUO JUNZHAO, DOCTOR 029-84775412 ADermenguo@126.com | |
Sponsors and Collaborators
Xijing Hospital
Investigators
| Study Chair: | LIU WENCHAO, PROFESSOR | xijing hospital of the fourth military medical univercity |
More Information
No publications provided
| Responsible Party: | Xijing Hospital |
| ClinicalTrials.gov Identifier: | NCT01493011 History of Changes |
| Other Study ID Numbers: | FMMU |
| Study First Received: | December 7, 2011 |
| Last Updated: | May 13, 2012 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Fever Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Body Temperature Changes Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013