Clinical trial NCT03545256: Sentinel. Ambulatory. Oral Cavity. Oropharynx (S.A.C.O)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer T1-N0 or T2-N0 of the Oral Cavity
Keywords: Outpatient
head neck cancer
Lymph node metastasis
surgery
Quality of life
economical study
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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, nanocolloide labeled with technetium99, around the primary tumor.

- 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.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Conversion rate in complete hospitalization or re-hospitalization within 10 days following the surgical procedure (D0)
timeFrame: From Day 0 to 10 days post surgery
Secondary outcomes:
measure: Acceptance rate of outpatient surgery
timeFrame: inclusion visit
measure: Description of complications attributable to outpatient care taken on Day 0, Day 10 and Month1
timeFrame: From Day 0 to Month 1 post surgery
measure: Quality of life at inclusion visit
timeFrame: Inclusion visit
measure: Quality of life at Day 0 visit
timeFrame: Day 0 visit
measure: Quality of life at Day 10 post surgery
timeFrame: Day 10 visit post surgery
measure: Quality of life at month 1 post surgery
timeFrame: Month 1 visit post surgery
measure: Evaluation of the cost of the strategy at Month 1
timeFrame: Month 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Gui de Chauliac Hospital, ENT Department 80 rue Augustin Fliche
state: Hérault
Study officials:
affiliation: CHU Montpellier Gui de Chauliac Hospital, Neuroscience Head and Neck Pole, ENT Department
name: Renaud GARREL, ENT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.