Clinical trial · Interventional
Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma
Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma (REDUCE-30)
NCT07497607CI-TRIAL-00111936REDUCE-30recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-arm, phase II study that is designed to investigate nodal and primary tumor CTV dose de-escalation (30 Gy) in HPV positive oropharyngeal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV Positive Oropharyngeal Squamous Cell Carcinoma | Human Papillomavirus-Related Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Oropharyngeal Squamous Cell Carcinoma | Oropharyngeal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Reduced Elective Nodal and CTV Dose
- description
- Reduction in primary tumor and nodal CTV dose to 30 Gy.
- interventionNames
- Drug: Cisplatin
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Change in dose and volume to all clinical target volumes (CTV) via Progression-Free Survival (PFS)
- timeFrame
- 2 years post treatment
- description
- To evaluate the efficacy of a reduction in dose and volume to all clinical target volumes (CTV) in patients with HPV-positive squamous cell carcinoma of the oropharynx (OPSCC) using 2-year Progression-Free Survival (PFS). Efficacy will be determined by the PFS rate at 2 years post-treatment, through continuous assessment with a boundary of 10% progression at 2 years (90% 2 year PFS).
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have histologically or cytologically confirmed history of squamous cell carcinoma of the oropharynx (OPSCC) planned for definitive chemoradiation. 2. Squamous cell carcinoma of the oropharynx (OPSCC) must be confirmed to be p16 positive based on immunohistochemical staining. 3. OPSCC must be clinical stage T1-4N1-3M0 or T3-T4N0M0 as per AJCC volume 8. 4. Patients must have measurable disease based on PET/CT imaging completed within 45 days +/- 1 week from date of eligibility confirmation. 5. Age ≥18 years. 6. ECOG performance status ≤2. 7. Patients must be deemed eligible for planned SOC cisplatin per treating investigators and/or treating medical oncologist. 8. Women of child-bearing potential and men must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 9. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * 1\. Patients with metastatic or recurrent disease. 2\. Carcinoma of the neck of unknown primary site origin (T0 is ineligible even if p16 is positive). 3\. Prior radiotherapy resulting in overlap of radiation therapy fields. 4\. Patients who are pregnant, nursing or intended to conceive or father children during the course of the study. 5\. Patients with active autoimmune or connective tissue disease that require systemic treatment in the opinion of the Investigator. 6\. Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the Investigator. 7\. Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous or not preferable, in the opinion of the Investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.