Non-small Cell Lung Cancer Stage IIIBWBH&NSCLCNCT01493011
Chemotherapy Combined With Whole-body Hyperthermia to Treat Stage IIIB/IV Non Small Cell Lung Cancer
A study testing chemotherapy & WBH in people with Non-small Cell Lung Cancer Stage IIIB and Toxicity Due to Chemotherapy, run by Xijing Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage IIIB, Toxicity Due to Chemotherapy
- What is being tested?
- chemotherapy & WBH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi’an, Shanxi, 710031
GUO JUNZHAO, DOCTOR, 029-84775412, ADermenguo@126.com
About this study
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)
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).
- Being tested
- chemotherapy & WBH
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapy & WBHDevice
standard first-line chemotherapy combined with whole-body hyperthemia to treat stage Ⅲb/Ⅳ NSCLC
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy & WBH | Experimental | Standard chemotherapy protocol combined with whole body hyperthermia Receives: Device: chemotherapy & WBH |
| chemotherapy | No intervention | standard chemotherapy protocol for advanced NSCLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: one year
Secondary outcomes (4)
Toxicity as assessed by NCI CTC v3.0
Measured: one year
overall suivival
Measured: one year
quality of life
Measured: one year
Disease Control Rate
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IIIBStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LIU WENCHAO, PROFESSOR, Study chair, xijing hospital of the fourth military medical univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493011
- Sponsor's protocol ID
- FMMU
- Acronym
- WBH&NSCLC
- Status last verified
- May 2012
- First submitted
- 7 Dec 2011
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01493011
- Acronym / sponsor ID
- WBH&NSCLC / FMMU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chemotherapy & WBH | Experimental | Device: chemotherapy & WBHStandard chemotherapy protocol combined with whole body hyperthermia |
| chemotherapy | No intervention | –standard chemotherapy protocol for advanced NSCLC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chemotherapy & WBHstandard first-line chemotherapy combined with whole-body hyperthemia to treat stage Ⅲb/Ⅳ NSCLC | Device | chemotherapy & WBH |
Primary outcome
Progression-free survival (PFS)
Time frame: one year
4 secondary outcomes
Toxicity as assessed by NCI CTC v3.0
Time frame: one year
overall suivival
Time frame: one year
quality of life
Time frame: one year
Disease Control Rate
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LIU WENCHAO, PROFESSOR study chair
xijing hospital of the fourth military medical univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chemotherapy & WBH in people with Non-small Cell Lung Cancer Stage IIIB and Toxicity Due to Chemotherapy, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LIU WENCHAO, professor (029-84775407, liuch@FMMU.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.