EUCTR2004-001101-10-AT
Active, not recruiting
Not Applicable
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
DrugsZometa
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients with unresectable stage IIIA and IIIB Non small cell lung cancer (NSCLC) without bone metastases
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 446
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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