NCT02671071 - 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)

Hellner K, Münger K
Human papillomaviruses as therapeutic targets in human cancer. J Clin Oncol. 2011 May 1;29(13):1785-94. doi: 10.1200/JCO.2010.28.2186. Epub 2011 Jan 10.
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D
Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):134.
Martínez-Mesa J, Werutsky G, Campani RB, Wehrmeister FC, Barrios CH
Inequalities in Pap smear screening for cervical cancer in Brazil. Prev Med. 2013 Oct;57(4):366-71. doi: 10.1016/j.ypmed.2013.06.026. Epub 2013 Jul 1.
Muñoz N, Franco EL, Herrero R, Andrus JK, de Quadros C, Goldie SJ, Bosch FX
Recommendations for cervical cancer prevention in Latin America and the Caribbean. Vaccine. 2008 Aug 19;26 Suppl 11:L96-L107. doi: 10.1016/j.vaccine.2008.05.062. Review.
Pearcey R, Brundage M, Drouin P, Jeffrey J, Johnston D, Lukka H, MacLean G, Souhami L, Stuart G, Tu D
Phase III trial comparing radical radiotherapy with and without cisplatin chemotherapy in patients with advanced squamous cell cancer of the cervix. J Clin Oncol. 2002 Feb 15;20(4):966-72.
Zuliani AC, Esteves SC, Teixeira LC, Teixeira JC, de Souza GA, Sarian LO
Concomitant cisplatin plus radiotherapy and high-dose-rate brachytherapy versus radiotherapy alone for stage IIIB epidermoid cervical cancer: a randomized controlled trial. J Clin Oncol. 2014 Feb 20;32(6):542-7. doi: 10.1200/JCO.2013.50.1205. Epub 2014 Jan 21.

Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study

Clinical trial NCT02671071 - References