| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Head and Neck Cancer | Radiation: Radiotherapy to all dissected areas Radiation: Omit radiation to pN0 neck | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 90 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects: A Randomized Trial |
| Actual Study Start Date : | September 6, 2019 |
| Estimated Primary Completion Date : | September 2026 |
| Estimated Study Completion Date : | September 2026 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Standard Radiotherapy
Radiotherapy to all dissected areas
|
Radiation: Radiotherapy to all dissected areas
Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas
|
|
Experimental: Radiotherapy to smaller treatment area
Omit radiation to pN0 neck
|
Radiation: Omit radiation to pN0 neck
post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| United States, Florida | |
| Miami Cancer Institute | Recruiting |
| Miami, Florida, United States, 33143 | |
| Contact: Noah Kalman, MD 786-596-2000 NoahK@baptisthealth.net | |
| Canada, Ontario | |
| London Regional Cancer Program | Recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Contact: David Palma, MD 519-685-8500 David.Palma@lhsc.on.ca | |
| Contact: Laura Bailey 519-685-8618 LauraD.Bailey@lhsc.on.ca | |
| United Kingdom | |
| Beatson West of Scotland Cancer Centre | Recruiting |
| Glasgow, United Kingdom, G12 OYN | |
| Contact: Claire Paterson, MD 0141 301 7066 Claire.Paterson2@ggc.scot.nhs.uk | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 14, 2019 | ||||
| First Posted Date ICMJE | June 25, 2019 | ||||
| Last Update Posted Date | June 10, 2021 | ||||
| Actual Study Start Date ICMJE | September 6, 2019 | ||||
| Estimated Primary Completion Date | September 2026 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Regional failure in the pN0 hemi-neck (s) [ Time Frame: Baseline to 5 years ] Rate of relapse in the pN0 neck in Arm 2 compared to historical controls
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial | ||||
| Official Title ICMJE | Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects: A Randomized Trial | ||||
| Brief Summary | 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. | ||||
| Detailed Description |
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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
| Condition ICMJE | Head and Neck Cancer | ||||
| Intervention ICMJE |
|
||||
| Study Arms ICMJE |
|
||||
| Publications * | 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. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
90 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | September 2026 | ||||
| Estimated Primary Completion Date | September 2026 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | |||||
| Listed Location Countries ICMJE | Canada, United Kingdom, United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03997643 | ||||
| Other Study ID Numbers ICMJE | PRESERVE | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE |
|
||||
| Responsible Party | Lawson Health Research Institute | ||||
| Study Sponsor ICMJE | Lawson Health Research Institute | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Lawson Health Research Institute | ||||
| Verification Date | June 2021 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||