Sentinel. Ambulatory. Oral Cavity. Oropharynx (S.A.C.O) (SACO)

Open Non-randomized Study on the Management of Operable T1-N0 or T2-N0 Oral Cavity and Oropharynx Cancer and Sentinel Lymph Node in Outpatient Surgery

This is a single-center pilot study of open-label, non-randomized interventional research based on the outpatient management of 30 patients with T1-N0 or T2-N0 cancer in the oral cavity or oropharynx.

Study Overview

• Status: Recruiting
• Conditions: Cancer T1-N0 or T2-N0 of the Oral Cavity
• Intervention / Treatment: Procedure: outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search

Detailed Description

Currently, patients with oral cancer or oropharynx T1-N0 or T2-N0 are treated by surgery on the tumor and the neck, both validated techniques are either with a systematic lymph node dissection or a search for lymph sentinel node (GS). The goal on the lymph sentinel nodes is to diagnose the presence of metastasis (s). With the GS technique, the length of hospital stay can be shorter. The limited invasiveness of tumor surgery of the oral cavity and oropharynx and GS and short postoperative monitoring is compatible with outpatient management, so it should be evaluated through a study clinical.

The main objective of this study is to evaluate the rate of conversion to complete hospitalization or re-hospitalization within 10 days of surgery J0. The secondary objectives are the evaluation of the acceptance rate of outpatient surgery by the eligible patient, complications related to outpatient management, the quality of life of the patient and the cost of the strategy over the first month following J0.

The surgical procedure associated with the sentinel lymph node technique is carried out in two stages:

- Lymphoscintigraphy at Day-1 : This is the identification of the lymphatic network of the patient by a prior injection of radioactive tracer, nanocolloids labeled with technetium99, around the primary tumor. A planar or 3-minute CT image acquisition is performed 30 to 60 minutes after injection in anteroposterior and lateral view to identify the sentinel lymph nodes (GS(s)) which are then marked on the skin with an indelible marker. This routine care examination is done in an external act.

- Surgery on D0: The patient is admitted to the hospital at 7:00 am in outpatient unit. He is reviewed by the anesthetist before the intervention and is transferred to the operating room for the intervention under General anesthesia.

The main tumor is operated by mouth. The ganglionic surgical procedure consists of the removal of the GS(s) by a limited cervical approach, following a cervical dissection line. The GS(s) are identified by a gamma detection probe, equipped with a high-resolution collimator whose tip is covered with a sterile disposable sleeve. Exeresis of the GS(s) is performed by removing the peri-ganglionic cellular tissue and avoiding any capsular intrusion. The GS lymph node (s) so taken is sent freshly by special request to the pathologist for final analysis according to the recommended procedure for GS.

The cervical dissection will be performed later if the definitive analysis finds a ganglionic invasion. In this case, the patient will be re-hospitalized in unit full hospitalization for cervical lymph node dissection: the ganglionic areas systematically concerned are the levels I, II, III and IV for tumors of the oral cavity and II, III and IV for the oropharynx. The gesture will be bilateral if the lymphoscintigraphy had found a bilateral drains. The cervical dissection parts are labeled and sent for routine final pathological analysis.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renaud GARREL, ENT; Phone Number: +33 467-336-920; Email: r-garrel@chu-montpellier.fr
• Study Contact Backup: Name: César CARTIER, ENT; Phone Number: +33 467-336-920; Email: c-cartier@chu-montpellier.fr

Study Locations

• France
  • Hérault
    • Montpellier, Hérault, France, 34295
      • Recruiting
      • Gui de Chauliac Hospital, ENT Department 80 rue Augustin Fliche
      • Contact: Angelina MARTINEZ, Site Study Coordinator; Phone Number: +33 467-336-156; Email: angelina-martinez@chu-montpellier.fr
      • Contact: Claire LEMAIRE, Study Nurse Manager; Phone Number: +33 467 336 896; Email: c-lemaire@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female over 18 years old with no upper age limit
• Patient (s) affiliated to a social security system, or beneficiary of such a system
• Patient information and informed consent signed by the patient
• Patient no longer participating in another trial since legal time
• Patient with primary squamous cell carcinoma of the oral cavity or oropharynx documented by biopsy with histological analysis less than 1 month old
• Tumor operable by TNM stage, location and general condition of the patient
• Systematic Oto-Rhino-Laryngology panendoscopy eliminating a second synchronous tumor and establishing precisely the T
• Stage T1 or T2, N0 and M0
• Proposal by a multidisciplinary meeting for tumor surgery and GS technique
• Eligibility criteria for ambulatory surgery present
• Anesthetic criteria for eligibility for outpatient hospitalization (ref AFAR 29 (2010) 67-72, formalized expert recommendations) including ASA I, II and III score stable
• Patient able to understand the nature, purpose and methodology of the study

Exclusion Criteria:

• lack of one of the inclusion criteria
• other cancer being treated
• non-infiltrating tumor: high grade dysplasia, carcinoma in situ
• insufficient tumor excision: invaded margins without complementary recovery in healthy zone
• contraindication to sentinel lymph node surgery or ganglion dissection
• contraindication to radiotherapy
• contraindications to performing a scintigraphy:
• Known allergy or intolerance to the injected product and in particular to Technetium-99
• Pregnancy
• Refusal to accept the entire treatment (nodal diagnosis on GS, lymph node dissection pN + follow-up of adjuvant radiotherapy if necessary)
• impossible to follow over 2 years
• refusal to accept the monitoring described and / or to provide the information necessary for the study
• patient already treated for this tumor outside of an excisional biopsy
• patient who previously had chemotherapy or immunotherapy for another cancer outside the VADS in a period of less than 6 months
• patient who has had cervical or VADS radiotherapy regardless of the cause or delay
• patient who has had previous cervical surgery regardless of cause or delay
• Patient protected by law (patient under guardianship).
• Patient (e) deprived of liberty by administrative decision.
• Pregnant or lactating women according to article L1121-5 of the CSP. An assay of βHCG will be performed routinely to ensure the absence of pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: T1-N0 or T2-N0 cancers of the oral cavity; outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search

Procedure: outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search; The surgical procedure associated with the sentinel lymph node technique is carried out in two stages: - Lymphoscintigraphy at Day-1 : This is the identification of the lymphatic network of the patient by a prior injection of radioactive tracer, nanocolloids labeled with technetium99, around the primary tumor. A planar CT image acquisition is performed to identify the sentinel lymph nodes (Gs(s)) which are then marked on the skin with an indelible marker. Surgery on D0: The patient is admitted to the hospital at 7:00 am in outpatient unit. He is reviewed by the anesthetist before the intervention and is transferred to the operating room for the intervention under AG. The main tumor is operated by mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion rate in complete hospitalization or re-hospitalization within 10 days following the surgical procedure (D0)	the conversion into complete hospitalization on the day of the procedure (Day 0) or re-hospitalization within 10 days following the surgical procedure (Day 0) respectively will be performed in case of medical or surgical complications or according to the doctor's opinion for the release of the patient, or in case of lymph nodes dissection	From Day 0 to 10 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance rate of outpatient surgery	Acceptance rate of outpatient surgery validated by the multidisciplinary meeting and proposed to the patient who meets the eligibility criteria for the inclusion visit	inclusion visit
Description of complications attributable to outpatient care taken on Day 0, Day 10 and Month1	All complications related to outpatient care will be recorded	From Day 0 to Month 1 post surgery
Quality of life at inclusion visit	self-questionnaire completed by the patient at inclusion visit, Score reported by the subjects on the Quality of life questionnaire QLQ-C30. The scores of the different scales are between 0 and 100. A score of the overall health of quality of life (QoL) close to 100 indicates a QoL close to perfect health. Similarly, a score of a functional scale close to 100 represents a level close to perfect capacity.	Inclusion visit
Quality of life at Day 0 visit	self-questionnaire completed by the patient at visit Day 0 visit, Scores reported by the subjects on the Quality of life questionnaires QLQ-H & N35. The questionnaire EORTC QLQ- H & N35 contains 35 questions that incorporate 7 multidimensional scales that assess pain, swallowing, senses (taste and smell), speech, socializing, social contacts, and sexuality during the previous week. It also includes 11 isolated items. The scoring approach for the QLQ-H & N35 questionnaire is identical in principle to that of the QLQC30 questionnaire symptom scales.	Day 0 visit
Quality of life at Day 10 post surgery	self-questionnaire completed by the patient at visit Day 10 visit, Scores reported by the subjects on the Quality of life questionnaires QLQ-H & N35. The questionnaire EORTC QLQ- H & N35 contains 35 questions that incorporate 7 multidimensional scales that assess pain, swallowing, senses (taste and smell), speech, socializing, social contacts, and sexuality during the previous week. It also includes 11 isolated items. The scoring approach for the QLQ-H & N35 questionnaire is identical in principle to that of the QLQC30 questionnaire symptom scales.	Day 10 visit post surgery
Quality of life at month 1 post surgery	self-questionnaire completed by the patient at inclusion Month 1 visit. Scores reported by the subjects on the Quality of life questionnaire SF-36.Score from the worst health condition imaginable (0) to the best state of health imaginable (100).	Month 1 visit post surgery
Evaluation of the cost of the strategy at Month 1	Description: The cost will be evaluated on the first month of outpatient management	Month 1

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Renaud GARREL, ENT, CHU Montpellier Gui de Chauliac Hospital, Neuroscience Head and Neck Pole, ENT Department

Publications and helpful links

General Publications

• Burcia V, Costes V, Faillie JL, Gardiner Q, de Verbizier D, Cartier C, Jouzdani E, Crampette L, Guerrier B, Garrel R. Neck restaging with sentinel node biopsy in T1-T2N0 oral and oropharyngeal cancer: Why and how? Otolaryngol Head Neck Surg. 2010 Apr;142(4):592-7.e1. doi: 10.1016/j.otohns.2009.12.016.
• Garrel R, Poissonnet G, Temam S, Dolivet G, Fakhry N, de Raucourt D. Review of sentinel node procedure in cN0 head and neck squamous cell carcinomas. Guidelines from the French evaluation cooperative subgroup of GETTEC. Eur Ann Otorhinolaryngol Head Neck Dis. 2017 Apr;134(2):89-93. doi: 10.1016/j.anorl.2016.10.004. Epub 2016 Nov 11.
• Schilling C, Stoeckli SJ, Haerle SK, Broglie MA, Huber GF, Sorensen JA, Bakholdt V, Krogdahl A, von Buchwald C, Bilde A, Sebbesen LR, Odell E, Gurney B, O'Doherty M, de Bree R, Bloemena E, Flach GB, Villarreal PM, Fresno Forcelledo MF, Junquera Gutierrez LM, Amezaga JA, Barbier L, Santamaria-Zuazua J, Moreira A, Jacome M, Vigili MG, Rahimi S, Tartaglione G, Lawson G, Nollevaux MC, Grandi C, Donner D, Bragantini E, Dequanter D, Lothaire P, Poli T, Silini EM, Sesenna E, Dolivet G, Mastronicola R, Leroux A, Sassoon I, Sloan P, McGurk M. Sentinel European Node Trial (SENT): 3-year results of sentinel node biopsy in oral cancer. Eur J Cancer. 2015 Dec;51(18):2777-84. doi: 10.1016/j.ejca.2015.08.023. Epub 2015 Nov 18.
• Lee MK, Nalliah RP, Kim MK, Elangovan S, Allareddy V, Kumar-Gajendrareddy P, Allareddy V. Prevalence and impact of complications on outcomes in patients hospitalized for oral and oropharyngeal cancer treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Nov;112(5):581-91. doi: 10.1016/j.tripleo.2011.06.032.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2018
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Outpatient; surgery; Lymph node metastasis; head neck cancer; economical study
• Other Study ID Numbers: 9787

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No