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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.
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.
The study will require a sample size of 90 patients randomized in a 2:3 between the two arms. Arm 1 (standard radiation therapy to tumor location and surrounding area) and Arm 2 (targeted radiation therapy to tumor location).
Patients will be followed for a total of 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Radiotherapy | Active Comparator | Radiotherapy to all dissected areas |
|
| Radiotherapy to smaller treatment area | Experimental | Omit radiation to pN0 neck |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy to all dissected areas | Radiation | Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas |
| Measure | Description | Time Frame |
|---|---|---|
| Regional failure in the pN0 hemi-neck (s) | Rate of relapse in the pN0 neck in Arm 2 compared to historical controls | Baseline to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Swallowing Quality of life | Assessed with the MD Anderson Dysphagia Inventory (MDADI) scale | Baseline up to 12 months |
| Swallowing Quality of life | Assessed with the EORTC QLQ-C30 scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Cancer Institute | Recruiting | Miami | Florida | 33143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40194704 | Derived | Evans 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. | |
| 32795322 |
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| Omit radiation to pN0 neck | Radiation | post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck |
|
| Baseline up to 12 months |
| Swallowing Quality of life | Assessed with the EORTC QLQ H&N 35 scale | Baseline up to 12 months |
| Health Status Quality of life | Assessed with the EORTC EQ-5D-5L scale | Baseline up to 12 months |
| Overall survival | Defined as time from randomization to death from any cause | Baseline to 5 years |
| Disease free survival | Defined as the measure of time after treatment during which no sign of cancer is found | Baseline to 5 years |
| Local recurrence | Defined as Cancer that has recurred at or near the same place as the primary tumor, usually after a period of time during which the cancer could not be detected. | Baseline to 5 years |
| Regional recurrence | Defined as recurrence that occurs in the lymph nodes and tissue located in the vicinity of your original cancer | Baseline to 5 years |
| Locoregional recurrence | Defined as the recurrence of cancer cells at the same site as the original tumor and/or the regional lymph nodes after a disease free period. | Baseline to 5 years |
| Rate of salvage treatment (surgery +/- radiotherapy) in the pN0 neck and freedom from unsalvageable neck recurrence | Rate of salvage treatment (surgery +/- radiotherapy) in the pN0 neck and freedom from | Baseline 5 years |
| Rate of feeding tub insertion and rate of feeding tube use at 1-year post randomization | Rate of feeding tub insertion and rate of feeding tube use at 1-year post randomization | Randomization to 1 year post randomization |
| Swallowing function | Measured by the Modified Barium Swallow Impairment (MBsimp) score | Baseline to 1 year |
| Swallowing function | Measured by the Dynamic Imaging Grade of Swallowing Toxicity score | Baseline to 1 year |
| Swallowing function | Measured by the Functional Oral Intake Score | Baseline to 1 year |
| Rate of toxicity | Assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 | Baseline to 5 years |
| Rate of failure in the clinically node negative neck | defined as time from randomization to failure in the cN0 neck | Baseline to 5 years |
| London Regional Cancer Program | Recruiting | London | Ontario | N6A 5W9 | Canada |
|
| CHUM | Recruiting | Montreal | Quebec | H2X 0A9 | Canada |
|
| Cork University Hospital | Recruiting | Wilton | County Cork | Ireland |
|
| University Hospital Galway, Newcastle Road | Recruiting | Galway | County Galway | H91 T861 | Ireland |
|
| St. Luke's Radiation Oncology Network | Recruiting | Rathgar | Dublin | Ireland |
|
| Beaumont St. Luke's Centre | Recruiting | Dublin | Leinster | D09FT51 | Ireland |
|
| Beatson West of Scotland Cancer Centre | Recruiting | Glasgow | G12 OYN | United Kingdom |
|
| Derived |
| Lang 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. |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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