Clinical trial · Interventional
Sentinel. Ambulatory. Oral Cavity. Oropharynx (S.A.C.O)
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
NCT03545256CI-TRIAL-00095976SACOrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer T1-N0 or T2-N0 of the Oral Cavity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- T1-N0 or T2-N0 cancers of the oral cavity
- description
- outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search
- interventionNames
- Procedure: outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search
Primary outcomes (1)
- 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
- description
- 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
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- RESULTBurcia 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. PMID 20304284
- RESULTGarrel 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. PMID 27842990
- RESULTSchilling 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. PMID 26597442
- RESULTLee 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. PMID 22035652