Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Central Nervous System Depressants

All Drugs and Chemicals

Coagulants

Anesthetics

Hemostatics

Tumor resection will be star first this accomplish with 1- 2 cm safety margin, Simultaneous neck dissection will be performed in all patient.

Flap dissection begins from the opposite side of the pedicle in the subplatysmal plane. Then the level 1a is dissected, the distal facial artery and facial vein to the branching point of the submental pedicle are ligated. The anterior belly of the digastric muscle on ipsilateral to the pedicle and strip of mylohyoid muscle will dissected off the mandible and the hyoid bone and included with the flap. This results in complete mobilization of the flap.A tunnel will be created between the defect and the donor site and the skin paddle of the flap will be transported through it intraorally and the flap is insetted.

contralateral submental flap for tongue cancer defect

Under general anesthesia the tumor will be resected with Preserving floor of mouth mucosa as much as possible to avoid restriction of tongue mobility. After Obtaining meticulous hemostasis, the tongue defect will be closed in layers.

primary closure for tongue cancer defect

Omer M Jamali, phd student

The purpose of this study is to compare the oncological and functional results of the contralateral submental flap with primary closure for reconstruction of tongue squamous cell carcinoma.

Resection of tongue malignancies remains one of most surgical challenges because of its adverse effects on speech articulation, swallowing, and eventual quality of life.

A variety of local flaps such as infrahyoid flap and the Platysma flap, and free flaps like the radial forearm and anterolateral thigh (ALT) flap have been available for reconstruction of tongue. However, all these options have their shortcomings.

When reconstructing particular oral cavity defect the tissue used should be reliable; functional and cosmetically acceptable with minimum donor site morbidity and match the recipient site in terms of color, texture and thickness. The submental island flap (SMI-flap) which has been first introduced by Martin et al in 1990, meets all these requirements and due to its optimal location, ease of harvest, and favorable arc of rotation, the SMI-flap has gained acceptance as a simple, reliable and convenient to repair defects of tongue and oral cavity cancer.

The oncological safety of submental flap in oral cancer patient still debate, this is due to its proximity to the main nodal basins of levels 1A and 1B and the possibility of transfer of occult metastatic lymph node to the recipient site during reconstruction.

in addition some authors has not been recommended submental flap for cases with clinically or radiologically established nodal disease as it might compromise the oncological resection and continuity of neck dissection and so alternative options should be considered. The contralateral submental island flap (CSMI-flap) is believed to offer such alternate option for patient with contralateral negative node.

our a priori-hypothesis is that utilization of the CSMI-flap is not related to an altered prognosis in tongue squamous cell carcinoma patients. In order to test this hypothesis, we will compare the oncological outcome of group of patients receive CSMI-flap with the results of another group of patients not receive CSMI-flap and close tongue defect by primary closure, which is another well-established concept of management tongue cancer defect.

Because the two interventions used in this trial are clearly different and easly recognized by the participants and investigators, neither investigators nor Participants can be blinded.

The statistician will be blinded.

Oncological Outcome of Contralateral Submental Artery Island Flap Versus Primary Closure in Tongue Squamous Cell Carcinoma

Oncological Outcome of Contralateral Submental Artery Island Flap Versus Primary Closure in Tongue Squamous Cell Carcinoma (Randomize Noninferiority Clinical Trial)

Cairo University

principal investigator

Mouth and Tooth Diseases

Rare Diseases

Mouth Neoplasms

Squamous Cell Carcinoma of Head and Neck

Lip Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Squamous Cell Carcinoma

Oral Cancer

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.

National Cancer Institute (NCI)

NRG Oncology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oncological Outcome of Contralateral Submental Artery Island Flap Versus Primary Closure in Tongue Squamous Cell Carcinoma	NCT03440151	Tongue Squamous...	contralateral s... primary closure...	-	Cairo University
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
Oncological Outcome of Contralateral Submental Artery Island Flap Versus Primary Closure in Tongue Squamous Cell Carcinoma	NCT03440151	Tongue Squamous...	contralateral s... primary closure...	-	Cairo University

Spots Global Cancer Trial Database for tongue squamous cell carcinoma