NCT01814969 - 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)

Gerard JP, Rostom Y, Gal J, Benchimol D, Ortholan C, Aschele C, Levi JM
Can we increase the chance of sphincter saving surgery in rectal cancer with neoadjuvant treatments: lessons from a systematic review of recent randomized trials. Crit Rev Oncol Hematol. 2012 Jan;81(1):21-8. doi: 10.1016/j.critrevonc.2011.02.001. Epub 2011 Mar 5. Review.
Suwinski R, Wydmanski J, Pawelczyk I, Starzewski J
A pilot study of accelerated preoperative hyperfractionated pelvic irradiation with or without low-dose preoperative prophylactic liver irradiation in patients with locally advanced rectal cancer. Radiother Oncol. 2006 Jul;80(1):27-32. Epub 2006 May 26.
Suwinski R, Wzietek I, Tarnawski R, Namysl-Kaletka A, Kryj M, Chmielarz A, Wydmanski J
Moderately low alpha/beta ratio for rectal cancer may best explain the outcome of three fractionation schedules of preoperative radiotherapy. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):793-9. Epub 2007 May 17.

Preoperative Hyperfractionated Radiotherapy Versus Combined Radiochemotherapy for Patients With Locally Advanced Rectal Cancer: a Phase III Randomized Trial.

Details for clinical trial NCT01814969

Clinical trial NCT01814969 - References