OncoMatch/Clinical Trials/NCT05894083
A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)
Is NCT05894083 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Chemoradiation for oropharyngeal cancer.
Treatment: Chemoradiation — Single center, non-randomized Phase II study enrolling Stage I-II p16+ oropharyngeal cancer patients to one of two de-escalation treatment paradigms: (1) receive surgery followed by observation or risk-adjusted adjuvant radiation (+/-chemo), or (2) individualized adaptive definitive chemoradiation (CRT).
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A overexpression (p16 positive by immunohistochemistry)
p16 positive by immunohistochemistry
Required: HPV positive by in situ hybridization (HPV positive by in situ hybridization)
HPV positive by in situ hybridization
Disease stage
Required: Stage I, II
Excluded: Stage CN3, CM1
Performance status
ZUBROD 0–1
Prior therapy
Cannot have received: any therapy for the study cancer
Any prior therapy for the study cancer
Cannot have received: radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Cannot have received: paclitaxel, carboplatin or other platinum containing products; products containing Cremophor EL (paclitaxel, carboplatin)
Prior allergic reaction or hypersensitivity reactions to paclitaxel, carboplatin or other platinum containing products. This also includes patients with a history of severe hypersensitivity reaction to products containing Cremophor EL.
Lab requirements
Blood counts
Adequate bone marrow function: ANC ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dL
Kidney function
Serum creatinine within normal institutional limits or a creatinine clearance ≥ 45 ml/min within 4 weeks prior to registration
Liver function
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects excluded; laboratory tests for liver function and coagulation parameters are not required for entry
CBC required within 4 weeks prior to registration; for Cohort B, CBC/differential obtained within 4 weeks prior to registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dL. Serum creatinine within normal institutional limits or a creatinine clearance ≥ 45 ml/min within 4 weeks prior to registration. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects excluded; laboratory tests for liver function and coagulation parameters are not required for entry.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Michigan Rogel Cancer Center · Ann Arbor, Michigan
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