Clinical trial · Interventional
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects: A Randomized Trial
NCT03997643CI-TRIAL-00068477recruitingPhase 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)
The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omit radiation to pN0 neck | Radiation | — | UNRESOLVED |
| Radiotherapy to all dissected areas | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Radiotherapy
- description
- Radiotherapy to all dissected areas
- interventionNames
- Radiation: Radiotherapy to all dissected areas
- type
- EXPERIMENTAL
- label
- Radiotherapy to smaller treatment area
- description
- Omit radiation to pN0 neck
- interventionNames
- Radiation: Omit radiation to pN0 neck
Primary outcomes (1)
- measure
- Regional failure in the pN0 hemi-neck (s)
- timeFrame
- Baseline to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Willing to provide informed consent * ECOG performance status 0-2 * Histologically confirmed, resected oral cavity squamous cell carcinoma with at least ipsilateral selective neck disection * Patient has pathological features that are indications for PORT: positive or close (≤ 3 mm) margin, presence of LVI or PNU, pT3 or pT4 disease, positive lymph nodes, and PORT is recommended by treating physician * Pathologically lympth node negative in at least one dissected hemi-neck with at least 10 nodes recovered in each pN0 hemi-neck Exclusion Criteria: * Serious medical comorbidities or other contraindications to radiotherapy * Prior history of head and neck cancer within 5 years * Any other active invasive malignancy, except non-melanotic skin cancers * Prior head and neck radiation at any time * Prior oncologic head and neck surgery in the oral cavity or neck * Metastatic disease * Locoregional disease recurrence identified following surgical resection but prior to the start of radiotherapy * Inability to attend full course of radio therapy or follow-up visits * Unable or unwilling to complete QoL questionnaires * Pregnant or lactating women
References
Publications (2)
- DERIVEDEvans M, Bonomo P, Chan PC, Chua MLK, Eriksen JG, Hunter K, Jones TM, Laskar SG, Maroldi R, O'Sullivan B, Paterson C, Tagliaferri L, Tribius S, Yom SS, Gregoire V. Post-operative radiotherapy for oral cavity squamous cell carcinoma: Review of the data guiding the selection and the delineation of post-operative target volumes. Radiother Oncol. 2025 Jun;207:110880. doi: 10.1016/j.radonc.2025.110880. Epub 2025 Apr 5. PMID 40194704
- DERIVEDLang P, Contreras J, Kalman N, Paterson C, Bahig H, Billfalk-Kelly A, Brennan S, Rock K, Read N, Venkatesan V, Sathya J, Mendez LC, MacNeil SD, Nichols AC, Fung K, Mendez A, Winquist E, Kuruvilla S, Stewart P, Warner A, Mitchell S, Theurer JA, Palma DA. Preservation of swallowing in resected oral cavity squamous cell carcinoma: examining radiation volume effects (PRESERVE): study protocol for a randomized phase II trial. Radiat Oncol. 2020 Aug 14;15(1):196. doi: 10.1186/s13014-020-01636-x. PMID 32795322