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NCT06563479
Phase III Randomized and Double-blinded Trial of De-escalated Radiation in FMISO PET-selected Good Risk Versus Standard of Care Radiation in Unselected HPV Positive Oropharyngeal Cancer
Phase 3 trial testing FMISO-PET Scan in HPV-Related Squamous Cell Carcinoma in 291 participants. Currently enrolling.
1 August 2027
Quick facts
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 291 |
| Start date | 19 August 2024 |
| Primary completion | 1 August 2027 |
| Estimated completion | 1 August 2027 |
| Sites | 9 locations across United States |
Drugs / interventions tested
- FMISO-PET Scan
- Chemoradiation — full drug profile →
- Chemoradiation — full drug profile →
- Assessments
Conditions studied
- HPV-Related Squamous Cell Carcinoma — all drugs for HPV-Related Squamous Cell Carcinoma →
Sponsor
Memorial Sloan Kettering Cancer Center — full company profile →
Who can join
18 and older, any sex, with HPV-Related Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
overall survival
Time frame: 2 years
The measurement of survival will be evaluated as a time from randomization to events endpoint (i.e., death due to any cause) so that censored data are allowed. To assess the overall survival rate, Kaplan-Meier estimates will be calculated and reported.
Sponsor's own description
The researchers are doing this study to find out if a personalized approach to chemoradiation therapy (which may include a lower dose of radiation) is as effective as the standard chemoradiation therapy in people with HPV-positive throat cancer. Other purposes of this study include looking at the following: * Whether a lower dose of radiation in combination with standard chemotherapy causes fewer side effects than the standard dose of radiation therapy in combination with standard chemotherapy * How the study approaches (lower dose of radiation therapy + standard chemotherapy and standard dose of radiation therapy + standard chemotherapy) affect participants' quality of life. The researchers will measure quality of life by having participants fill out questionnaires.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Precision therapeutic targets for HPV-positive cancers: an overview and new insights.
Huang Y, Wang J, Yang W, Hou F, et al · · 2025 · cited 4× · PMID 40069817 · DOI 10.1186/s13027-025-00641-7 -
Selection Criteria for De-Escalated Chemoradiotherapy for HPV-Related Oropharyngeal Cancer Based on Prognostic Biomarkers or Early Tumor Response to Therapy: A Narrative Review †
Eisbruch A, Sreeram M, Rao K, Agaimy A, et al · · 2026
Verify or expand the search:
- PubMed search for NCT06563479
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for HPV-Related Squamous Cell Carcinoma
Currently open trials in the same condition.
- NCT05639972 — E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers · Phase 1, PHASE2 · recruiting
- NCT05973487 — A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metasta · Phase 1 · active not recruiting
- NCT05686226 — E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers · Phase 2 · recruiting
- NCT04900623 — Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study · Phase 2 · recruiting
- NCT04369937 — HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cel · Phase 2 · active not recruiting
Other Memorial Sloan Kettering Cancer Center trials
Trials by the same sponsor.
- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
- NCT07507643 — A Study of Methylprednisolone in People Having Liver Surgery · Phase 3 · recruiting
- NCT07483307 — A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer · Phase 2 · recruiting
- NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
- NCT07449195 — A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06563479 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
- Last refreshed: 2 June 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06563479.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing