Chemotherapy Combined With Whole-body Hyperthermia to Treat Stage IIIB/IV Non Small Cell Lung Cancer (NCT01493011) | Clinical Trial Compass
UnknownNot Applicable
Chemotherapy Combined With Whole-body Hyperthermia to Treat Stage IIIB/IV Non Small Cell Lung Cancer
China120 participantsStarted 2011-11
Plain-language 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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines standard chemotherapy with whole-body hyperthermia — can you explain what whole-body hyperthermia actually involves physically, and what side effects or risks come specifically from raising my entire body temperature during treatment?
2The trial's recruitment status is listed as unknown, which may mean it's no longer actively enrolling — do you know whether this study is still open, and if not, are there similar trials combining heat-based treatments with chemotherapy that I could look into?
3Since this trial is for Stage IIIB or IV non-small cell lung cancer and is measuring progression-free survival, how does that outcome compare to what I might expect from the standard chemotherapy regimens currently available to me?
4This trial doesn't have a standard phase listed, which makes it harder to know how much safety and effectiveness data already exists — what do you know about the evidence behind whole-body hyperthermia in lung cancer, and how confident are you in its safety profile?
5Given that I'd be receiving chemotherapy alongside a whole-body hyperthermia procedure, how demanding would the treatment schedule likely be in terms of hospital visits, recovery time, and how I might feel day-to-day — and is that realistic given my current situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;
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