Finished
Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer
NCT03107182 · University of Chicago · Updated 6 May 2025
- What is being tested
- nab-paclitaxel; Carboplatin; Nivolumab; Cisplatin; Hydroxyurea; 5-FU; Dexamethasone; Famotidine; Diphenhydramine; Paclitaxel; Transoral robotic surgery (TORS); Adjuvant RT; Chemoradiotherapy
- For
- HPV-Related Squamous Cell Carcinoma; HNSCC
- Kind of study
- Tests a treatment or device on volunteers. Phase 2.
- Who can join
- Ages 18 years and older. About 72 people. The full rules are on the registry page.
- Where
- United States
- When
- Starts or started 27 June 2017, ends 6 Sept 2024. Registered 11 April 2017.
- Results
- Posted on the registry on 6 May 2025.
In the researchers' words
Carboplatin, nab-paclitaxel, and nivolumab combination will be administered for three cycles of three weeks duration each. TORS or RT/CRT will be performed after induction chemotherapy (i.e. day 64 of therapy). Patients with low risk and small volume tonsillar disease (T1-T2, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) or base of tongue disease (T1-2 with lateralized primary ≤3 cm, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) who have ≥50% reduction by RECIST following induction chemotherapy will undergo TORS and selective nodal dissection. De-intensified adjuvant RT will be given for adverse pathologic features. Patients may refuse TORS treatment. Patients with low risk, who do not qualify for TORS (due to volume of disease or poor visualization/access) or refuse TORS, who have ≥50% reduction by RECIST following induction chemotherapy will be given de-intensified treatment with radiation alone to 50 Gy. Before induction chemotherapy, patients will undergo examination under anesthesia and direct laryngoscopy to tattoo and photograph the primary tumor to plan the post-induction resection. Adjuvant nivolumab will be offered to all patients for 6-months post completion of definitive therapy (7 doses given as a flat dose of 480mg, every four weeks).
Sites
- University of Chicago Medical CenterChicago, Illinois, United States
