A prospective, multicenter, randomized phase III study to evaluate the efficacy of Zometa (zoledronic acid) in delaying progression or recurrence in patients with stage III non-small cell lung cancer
- Conditions
- Patients with unresectable stage IIIA and IIIB Non small cell lung cancer (NSCLC) without bone metastases
- Registration Number
- EUCTR2004-001101-10-HU
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 446
• Age = 18 years
• Histologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, large cell
carcinoma) NOTE: Mixed tumors with small cell carcinoma and aplastic carcinoma are not eligible
• Stage IIIA and Stage IIIB at diagnosis excluding patients with pleural effusion at the time of randomization
• Life expectancy of at least 6 months
• ECOG performance status of 0 or 1 (Post-text suppl. 1)
• Weight loss = 10% in the 6 months before diagnosis of NSCLC
• Women of childbearing potential must use a medically acceptable form of contraception
during the study and must have a negative urine or serum pregnancy test within 7 days of
randomization.
• Adequate bone marrow reserve defined as white blood cell (WBC) = 3500mm3,
neutrophils = 1500 mm3, platelets = 100,000 mm3, Hb = 9 g/dL
• Able and willing to sign informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• Patients with NSCLC with pleural effusion at the time of randomization
• Patients who received any prior bisphosphonates in past 12 months
• Presence of metastasis
• Patients with current malignancy within past 5 years other than NSCLC (exceptions
include treated melanoma, ductal carcinoma in situ of the cervix or other cancer cured by reception alone)
• Patients who have received radiotherapy = 3 weeks before randomization must have recovered from any adverse events occurring during radiotherapy
• Previous thoracotomy must have been performed = 3 weeks prior to randomization and patient must have recovered.
• Any previous radiotherapy completed < 3 weeks before randomization
• Patients with abnormal renal function (Creatinine > 3mg/dL)
• Corrected serum calcium < 8.0 mg/dL
• Known hypersensitivity to Zometa or other bisphosphonates
• Patients with nonmalignant conditions which would confound the evaluation of the
primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol,
including:
- Uncontrolled infections
- Uncontrolled Type 2 Diabetes Mellitus
- Diseases with influence on bone metabolism such as Paget’s disease or uncontrolled thyroid or parathyroid dysfunction
- Cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which
would prevent prolonged follow-up
• Patients who, in the opinion of the investigator, are unlikely to cooperate fully during the study
• More than 8 months from the start of the primary antitumor treatment
• Patients in whom the primary antitumor treatment is still ongoing
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method