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

• Sponsor: Xijing Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01493011
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer Stage IIIB; Toxicity Due to Chemotherapy	Device: chemotherapy & WBH	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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)
• Study Start Date: Nov 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2012
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Progression-free survival (PFS) [one year]

Secondary Outcome Measures

1. Toxicity as assessed by NCI CTC v3.0 [one year]

2. overall suivival [one year]

3. quality of life [one year]

4. Disease Control Rate [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xijing Hospital	Xi'an	Shanxi	China	710031

Sponsors and Collaborators

• Xijing Hospital

Investigators

• Study Chair: LIU WENCHAO, PROFESSOR, xijing hospital of the fourth military medical univercity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xijing Hospital
• ClinicalTrials.gov Identifier: NCT01493011
• Other Study ID Numbers: FMMU
• First Posted: Dec 15, 2011
• Last Update Posted: May 15, 2012
• Last Verified: May 1, 2012

• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Hyperthermia

Study Results

No Results Posted as of May 15, 2012