NCT03790384 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cui J, Wang W, Chen S, Chen P, Yang Y, Guo Y, Zhu Y, Chen F, Shi B
Combination of Intravesical Chemotherapy and Bacillus Calmette-Guerin Versus Bacillus Calmette-Guerin Monotherapy in Intermediate- and High-risk Nonmuscle Invasive Bladder Cancer: A Systematic Review and Meta-analysis. Medicine (Baltimore). 2016 Jan;95(3):e2572. doi: 10.1097/MD.0000000000002572. Review.
Kaasinen E, Wijkström H, Rintala E, Mestad O, Jahnson S, Malmström PU
Seventeen-year follow-up of the prospective randomized Nordic CIS study: BCG monotherapy versus alternating therapy with mitomycin C and BCG in patients with carcinoma in situ of the urinary bladder. Scand J Urol. 2016 Oct;50(5):360-8. doi: 10.1080/21681805.2016.1210672. Epub 2016 Aug 15.
Solsona E, Madero R, Chantada V, Fernandez JM, Zabala JA, Portillo JA, Alonso JM, Astobieta A, Unda M, Martinez-Piñeiro L, Rabadan M, Ojea A, Rodriguez-Molina J, Beardo P, Muntañola P, Gomez M, Montesinos M, Martinez Piñeiro JA; Members of Club Urológico Español de Tratamiento Oncológico
Sequential combination of mitomycin C plus bacillus Calmette-Guérin (BCG) is more effective but more toxic than BCG alone in patients with non-muscle-invasive bladder cancer in intermediate- and high-risk patients: final outcome of CUETO 93009, a randomized prospective trial. Eur Urol. 2015 Mar;67(3):508-16. doi: 10.1016/j.eururo.2014.09.026. Epub 2014 Oct 6.

The Effects of Sequential Mitomycin and Bacillus Calmette-Guérin Treatment Versus Bacillus Calmette-Guérin Monotherapy in Patients With High Risk Non-Muscle Invasive Bladder Cancer

Details for clinical trial NCT03790384

Clinical trial NCT03790384 - References