Nasopharyngeal Cancer
Conditions
Brief summary
The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic treatment alone.
Interventions
DRUGZometa (zoledronic acid)
Zometa 4 mg IV infusion every 4 weeks for 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily
Sponsors
Novartis
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age \>18, either sex * Histologically confirmed stage IV nasopharyngeal cancer * One bone metastasis at least confirmed by imaging * without chemotherapy or radiotherapy after bone metastasis * Life expectancy \> 6 M * ECOG \<= 2 * Adequate bone marrow reserve (WBC \> 3.5 x 109/L, Neutrophile \> 1.5 x 109/L, Platelet 100 x 109/L, Hb \> 90 g/L) * Serum creatinine\< 2.0 mg/dL (\< 1.5 times the upper limit of the normal range for the laboratory of the study center) * Signed ICF
Exclusion criteria
* Women who are pregnant or in lactation * Patients with hyperostosis * Systemic treatment for another cancer within the year prior to study entry * Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy * Initial serum creatinine \>265 micromol/L and/or progressive renal disease * Known hypersensitivity to any of the study drugs or to drugs with similar chemical structures * Use of investigational agents within 28 days of the Baseline visit, or participating simultaneously in any other clinical studies * Severe co-morbidity of any type that may interfere with assessment of the patient for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . | Baseline, the first, second and third month |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Group Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy. | 30 |
| Control Group Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 6 |
| Overall Study | Lack of Efficacy | 2 | 2 |
Baseline characteristics
| Characteristic | Control Group | Test Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 30 Participants | 59 Participants |
| Age Continuous | 41 years STANDARD_DEVIATION 11 | 46 years STANDARD_DEVIATION 10 | 44 years STANDARD_DEVIATION 11 |
| Region of Enrollment China | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 27 Participants | 25 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 30 | 16 / 29 |
| serious Total, serious adverse events | 15 / 30 | 17 / 29 |
Outcome results
Primary
Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms .
Time frame: Baseline, the first, second and third month
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Test Group | Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . | the second month | 17 nM /mM | Standard Error 7 |
| Test Group | Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . | the first month | 29 nM /mM | Standard Error 12 |
| Test Group | Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . | the third month | 11 nM /mM | Standard Error 20 |
| Test Group | Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . | Baseline | 75 nM /mM | Standard Error 15 |
| Control Group | Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . | the third month | 45 nM /mM | Standard Error 27 |
| Control Group | Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . | the first month | 88 nM /mM | Standard Error 23 |
| Control Group | Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . | the second month | 52 nM /mM | Standard Error 21 |
| Control Group | Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . | Baseline | 94 nM /mM | Standard Error 16 |
p-value: 0.37Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.01Wilcoxon (Mann-Whitney)