CClinicalTrials.gg
Status unknownNCT01493011WBH&NSCLCUpdated May 15, 2012

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

An interventional study of chemotherapy & WBH in Non-small Cell Lung Cancer Stage IIIB and Toxicity Due to Chemotherapy, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-05-15.

Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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).

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Conditions studied

  • Non-small Cell Lung Cancer Stage IIIB
  • Toxicity Due to Chemotherapy
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 120 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    chemotherapy & WBH

    Standard chemotherapy protocol combined with whole body hyperthermia

    Device: chemotherapy & WBH

  • No intervention
    chemotherapy

    standard chemotherapy protocol for advanced NSCLC

Interventions

  • Devicechemotherapy & WBH

    standard first-line chemotherapy combined with whole-body hyperthemia to treat stage Ⅲb/Ⅳ NSCLC

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What researchers measure

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: one year

Secondary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Xijing Hospital
    Xi'an, Shanxi 710031, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01493011
Lead sponsor
Xijing Hospital
Responsible party
Sponsor
First posted
Dec 15, 2011
Start date
Nov 2011
Primary completion
Dec 2012 (estimated)
Completion
Dec 2015 (estimated)
Last update
May 15, 2012

Study contacts

LIU WENCHAO, professor
Contact
liuch@FMMU.edu.cn
029-84775407
LIU WENCHAO, PROFESSOR
study chair · xijing hospital of the fourth military medical univercity

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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