Neoplasms

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Mouth Neoplasms

Tongue Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Tongue Diseases

Oral Squamous Cell Carcinoma

Oral Cancer

Tongue Cancer

resection of tongue cancer will be done with assistance of ultrasound to visualise the deep margin.

enrolled patients will be investigated by ultrasound two times, awake in the clinic and in narcosis before the surgery. For those with tongue cancer ultrasound will be used during the surgery to visualise the deep margin of the tumour.

Ultrasound

Johan Knutsson, Assoc. Prof.

The purpose of this study is to investigate if ultrasound can be helpful in the diagnostic work-up of oral tongue and floor of the mouth cancer. One important factor is how deeply the tumour invades the tissue, the so called depth of invasion (DOI). The investigator will measure DOI with ultrasound and compare the result with the same measurement by magnetic resonance imaging and the microscopic result after the surgery (PAD).

Ultrasound will also be used during surgery of the tumour to investigate if it is useful to better decide the depth of the tumour and thereby improving the operation.

The first part of this study will try to answer if ultrasound can improve the preoperative measurement of depth of invasion in tongue cancer and floor of the mouth cancer. The study population is new patients meeting the eligibility criteria presented to the hospital for treatment. Participants will be enrolled only after accepting the oral and written information and signing the written consent paper.

The examiner, one of three otorhinolaryngologists experienced in ultrasound, should be masked to the results of MRI. The first measurement is depth of invasion as well as thickness of the tumour in mm by palpation on awake patient. Thereafter the same measurements by ultrasound (BK Medical Medical flex focus 500, 18Mhz) with gel and protective cover is made with 0,5mm accuracy. Anesthetic gel or lingual block with carbocaine/adrenaline are provided as needed.

At the time of surgery the measurements above are done again on the patient in narcosis before the resection.

Images of the ultrasound measurements are saved for documentation. The results are compared to the corresponding measurements on MRI and also on PAD from the surgical specimen. PAD is considered gold standard.

Power calculation with help of biostatistician yielded a sample size of 55 patients, using a paired test with a 0,050 one-sided significance level will have 80% power to reject the null hypothesis that the proportions are not equivalent.

Analysis if ultrasound correctly classify the tumour´s DOI according to the TNM-classification 8th edition (\<5mm, \>5mm\<10mm, \>10mm) will be made.

The second part of the study will investigate if ultrasound during the surgical procedure can improve the discrimination of the deep margin of the tumour and thereby increasing the chance better surgical margins. The mucosal margins are marked in the usual fashion and the resection begins. After one fourth of the resection has been made, ultrasound is used to check that the deep margin is at least 10mm. This is repeated after one half and three quarters of the resection. At the end of the surgery a final ultrasound examination is made on the surgical specimen.

The margins obtained on PAD from resections done with ultrasound are compared to a matched retrospective group where the surgery was done without ultrasound.

After inclusion started our group started cooperation with another biostatician whom judged the analysis better be done from the quantitative variable of DOI in millimeter. This meant the power analysis shifted and a study population of between 15-23 participants was considered sufficient. Since the original plan was 55 participants we kept that number but after an interim analysis in may 2021 a total of 42 participants is now what we consider relevant in the study of DOI.

In our second endpoint studying ultrasound and surgical margin the interim analysis concluded that collection of patients for 2 years (may 2019 until may 2021) will be compared to a historical control group 4 years back in time (may 2015 until may 2019) and therefore the inclusion of that data stopped in may 2019.

The ultrasound examiner should not be aware of the results of the MRI.

Ultrasound in Tongue Cancer- a Help to Decide Depth of Invasion and to Improve the Surgical Margin

Ultrasound in Oral Tongue Cancer- Measurement of Depth of Invasion and Intraoperative Help in the Resection

Depth of invasion in millimeters measured by ultrasound compared to Clinical palpation , MRI and PAD.

Comparison of surgical margins in resections done with and without the assistance of ultrasound.

Region Örebro County

Squamous Cell Carcinoma of Head and Neck

Lip Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Lip and Oral Cavity Cancer

Patients receive an imaging agent via injection and undergo planar imaging and SPECT/CT over 1-2 hours. Patients then undergo SLN biopsy.

Computed Tomography (CT)

Imaging Agent

Undergo standard elective neck dissection

Neck Dissection

Planar Imaging

Sentinel Lymph Node Biopsy

Single Photon Emission Computed Tomography

Site Public Contact

Steven J. Wang

Emre A. Vural

Ellie G. Maghami

Theresa Guo

Fred Baik

Saral Mehra

Francisco J. Civantos

Jennifer Gross

Sandeep Samant

Mihir K. Bhayani

Nitin A. Pagedar

Andres M. Bur

John Pang

Steven B. Chinn

John D. Cramer

Eleanor M. Walker

Aru Panwar

Jennifer R. Cracchiolo

Dylan F. Roden

Ryan P. McSpadden

Umamaheswar Duvvuri

Jamie A. Ku

Amit Agrawal

Rusha J. Patel

Nitya Alluri

Nicholas Purdy

David M. Cognetti

Mark Kubik

Daniel Almquist

William C. Spanos

John P. Gleysteen

Michael C. Topf

Ann M. Gillenwater

Vlad C. Sandulache

Mirabelle Sajisevi

John R. de Almeida

Stephen Y Lai

This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.

PRIMARY OBJECTIVES:

I. To determine if patient-reported neck and shoulder function and related quality of life (QOL) at 6 months after surgery using the Neck Dissection Impairment Index (NDII) is superior with sentinel lymph node (SLN) biopsy compared to elective neck dissection (END) for treatment of early-stage oral cavity squamous cell carcinoma (OCSCC) (cT1-2N0). (Phase II) II. To determine if disease-free survival (DFS) is non-inferior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III) III. To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using NDII is superior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III)

SECONDARY OBJECTIVES:

I. To compare patterns of failure (local-regional relapse and distant metastasis) between surgical arms.

II. To measure and compare overall survival (OS) between surgical arms. III. To measure and compare the toxicity of the two surgical arms.

IV. To measure longitudinal patient-reported neck and shoulder function and related QOL between surgical arms, using the following instruments:

IVa. Neck Dissection Impairment Index (NDII). IVb. Abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH). IVc. Functional Assessment of Cancer Therapy-Head and Neck (FACT-H\&N). V. To assess the length of hospitalization, post-operative drain placement, and operative morbidity between arms.

VI. To estimate the negative predictive rate of fludeoxyglucose F-18 (FDG)-positron emission tomography/computed tomography (PET/CT) for N0 neck in patients with T1 and T1-2 oral cavity squamous cell cancer (OCSCC) patients in the END arm.

VII. To assess nodal metastases rates between arms. VIII. To assess the pathologic false omission rate (FOR) in the SLN biopsy arm. IX. To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using the NDII is superior with the SLN biopsy compared to the END in low-risk patients.

EXPLORATORY OBJECTIVES:

I. To compare changes in patient-reported outcomes (European Quality of Life Five Dimension Five Level Scale Questionnaire \[EQ-5D-5L\]) between surgical arms.

II. To collect biospecimens for future translational science studies. III. To assess the DFS between arms in low-risk patients.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive an imaging agent via injection and undergo planar imaging and single photo emission computed tomography/computed tomography (SPECT/CT) over 1-2 hours. Patients then undergo SLN biopsy.

GROUP II: Patients undergo standard END.

After completion of study treatment, patients are followed up 3 weeks after surgery, every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, then yearly thereafter.

Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer

Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer

Will be evaluated and compared using the Neck Dissection Impairment Index (NDII), a 10-item tool between the two treatment arms. It is assumed that a 7.5-point (change from Baseline to 6 months) between arm difference is clinically meaningful. The hypothesis of no between-arm difference in 6-month NDII scores will be tested using the ANCOVA model at one-sided significance level of 0.10. Point estimates and 95% confidence intervals (CIs) for the mean NDII scores at 6 months for each treatment arm and for the between-arm difference at 6-months based on the proposed model will be provided.

An event for disease-free survival is local recurrence, regional recurrence, distant metastasis, or death due to any cause. Disease-free survival time is randomization date to the date of event or last known follow-up (censoring). Rates will be estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test.

An event for overall survival is death due to any cause. Overall survival time is randomization date to date of event or last known follow-up (censoring). Rates will be estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test.

An event for local-regional failure is local or regional recurrence. Local-regional failure time is randomization date to date of event, precluding event, or last known follow-up (censoring). Rates will be estimated using the cumulative incidence method and between arm differences compared using cause-specific log-rank test.

An event is the occurrence of distant metastasis. Distant metastasis time is randomization to date of event, precluding event, or last known follow-up (censoring). Rates will be estimated using the cumulative incidence method and between-arm differences compared using cause-specific log-rank test.

Patient reported using Abbreviated Disabilities of the Arm, Shoulder, and Hand (QuickDASH) with scores of 0-100. A higher score indicates greater disability.

Will be measured using the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H\&N) to measure Functional Assessment of Cancer Therapy-Head and Neck-Trial Outcome Index (FACT-TOI) scores on a scale from 0-96. A higher score indicates better quality of life.

Defined as the proportion of patients with pathologic positive nodes using the pathology results.

Measured within the sentinel lymph node biopsy (SLN) arm only. Defined as the proportion of patients with false negative results among negative SLN patients.

Measured by NDII in low-risk oral cavity squamous cell carcinoma patients using ANCOVA comparison model.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ultrasound in Tongue Cancer- a Help to Decide Depth of Invasion and to Improve the Surgical Margin	NCT04059861	Tongue Cancer Floor of Mouth ...	Ultrasound	18 Years -	Region Örebro County
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer	NCT04333537	Buccal Mucosa S... Floor of Mouth ... Gingival Squamo... Hard Palate Squ... Lip Squamous Ce... Lower Alveolar ... Oral Cavity Squ... Retromolar Trig... Stage I Lip and... Stage II Lip an... Tongue Squamous... Upper Alveolar ...	Computed Tomogr... Imaging Agent Neck Dissection Planar Imaging Sentinel Lymph ... Single Photon E...	18 Years -	NRG Oncology
Ultrasound in Tongue Cancer- a Help to Decide Depth of Invasion and to Improve the Surgical Margin	NCT04059861	Tongue Cancer Floor of Mouth ...	Ultrasound	18 Years -	Region Örebro County

Spots Global Cancer Trial Database for floor of mouth squamous cell carcinoma