NCT03821064 - 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)

Cramer JD, Speedy SE, Ferris RL, Rademaker AW, Patel UA, Samant S
National evaluation of multidisciplinary quality metrics for head and neck cancer. Cancer. 2017 Nov 15;123(22):4372-4381. doi: 10.1002/cncr.30902. Epub 2017 Jul 20.
Divi V, Chen MM, Hara W, Shah D, Narvasa K, Segura Smith A, Kelley J, Rosenthal EL, Porter J
Reducing the Time from Surgery to Adjuvant Radiation Therapy: An Institutional Quality Improvement Project. Otolaryngol Head Neck Surg. 2018 Jul;159(1):158-165. doi: 10.1177/0194599818768254. Epub 2018 Apr 10.
Graboyes EM, Garrett-Mayer E, Ellis MA, Sharma AK, Wahlquist AE, Lentsch EJ, Nussenbaum B, Day TA
Effect of time to initiation of postoperative radiation therapy on survival in surgically managed head and neck cancer. Cancer. 2017 Dec 15;123(24):4841-4850. doi: 10.1002/cncr.30939. Epub 2017 Aug 25.
Graboyes EM, Garrett-Mayer E, Sharma AK, Lentsch EJ, Day TA
Adherence to National Comprehensive Cancer Network guidelines for time to initiation of postoperative radiation therapy for patients with head and neck cancer. Cancer. 2017 Jul 15;123(14):2651-2660. doi: 10.1002/cncr.30651. Epub 2017 Feb 27.
Huang J, Barbera L, Brouwers M, Browman G, Mackillop WJ
Does delay in starting treatment affect the outcomes of radiotherapy? A systematic review. J Clin Oncol. 2003 Feb 1;21(3):555-63. Erratum in: J Clin Oncol. 2003 Apr 1;21(7):1424.
Ohlstein JF, Brody-Camp S, Friedman S, Levy JM, Buell JF, Friedlander P
Initial Experience of a Patient Navigation Model for Head and Neck Cancer. JAMA Otolaryngol Head Neck Surg. 2015 Sep;141(9):804-9. doi: 10.1001/jamaoto.2015.1467.

Single-arm, Phase II Study Evaluating the Clinical Impact of Navigation on Delays and Racial Disparities Starting Postoperative Radiation Therapy for Adults With Locally Advanced Head and Neck Cancer: The NDURE Study

Details for clinical trial NCT03821064

Clinical trial NCT03821064 - References