drugset / Trial / NCT02215265
Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS)
Phase 3
Active not recruiting
1269 enrolled
Lisette Nixon
AdventHealth · collabPrincess Alexandra Hospital, Brisbane, Australia · collabStanford University · collabUNICANCER · collabUniversity of Leipzig · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The main objectives of the PATHOS study are: To assess whether swallowing function can be improved following transoral resection of HPV-positive OPSCC, by reducing the intensity of adjuvant treatment protocols. The aim is to personalise treatment, based on disease biology (HPV status and pathology findings), to optimise patient outcomes. To demonstrate the non-inferiority of reducing the intensity of adjuvant treatment protocols in terms of overall survival in the reduced intensity treatment arms.
Timeline
- Start
- 2015-10
- Primary completion
- 2027-10
- Completion
- 2028-04
Publications
- O'Hara JT, Hurt CN, Ingarfield K, Patterson JM, Hutcheson K, Canham JE, Nixon LS, Heiberg CD, Johson S, Evans M, Jones TM. Transoral Laser or Robotic Surgery Outcomes for Oropharyngeal Carcinoma: Secondary Analysis of the PATHOS Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Oct 10;150(11):1002-11. doi: 10.1001/jamaoto.2024.3371. Online ahead of print.
- Owadally W, Hurt C, Timmins H, Parsons E, Townsend S, Patterson J, Hutcheson K, Powell N, Beasley M, Palaniappan N, Robinson M, Jones TM, Evans M. PATHOS: a phase II/III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV) positive oropharyngeal cancer. BMC Cancer. 2015 Aug 27;15:602. doi: 10.1186/s12885-015-1598-x.