Cancer T1-N0 or T2-N0 of the Oral CavitySACONCT03545256
Sentinel. Ambulatory. Oral Cavity. Oropharynx (S.A.C.O)
A study testing outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search in people with Cancer T1-N0 or T2-N0 of the Oral Cavity, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer T1-N0 or T2-N0 of the Oral Cavity
- What is being tested?
- outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2018to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Gui de Chauliac Hospital, ENT Department 80 rue Augustin Fliche
Montpellier, Hérault, 34295
Angelina MARTINEZ, Site Study Coordinator, +33 467-336-156, angelina-martinez@chu-montpellier.fr
Claire LEMAIRE, Study Nurse Manager, +33 467 336 896, c-lemaire@chu-montpellier.fr
About this study
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
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.
Read the 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.
- Conditions
- Cancer T1-N0 or T2-N0 of the Oral Cavity
- Being tested
- outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search
- Keywords
- Outpatient, head neck cancer, Lymph node metastasis, surgery, Quality of life, economical study
- Medical subject headings
- Head and Neck Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node searchProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| T1-N0 or T2-N0 cancers of the oral cavity | Other | outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search Receives: Procedure: outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Day 0 to 10 days post surgery
Secondary outcomes (7)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start31 May 2018
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cancer T1-N0 or T2-N0 of the Oral CavityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renaud GARREL, ENT, Principal investigator, CHU Montpellier Gui de Chauliac Hospital, Neuroscience Head and Neck Pole, ENT Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545256
- Sponsor's protocol ID
- RECHMPL17_0165
- Acronym
- SACO
- Status last verified
- Sep 2025
- First submitted
- 7 May 2018
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 20304284Garrel 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.
PubMed 27842990Schilling 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.
PubMed 26597442Lee 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.
PubMed 22035652
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03545256
- Acronym / sponsor ID
- SACO / RECHMPL17_0165
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 31 May 2018 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| T1-N0 or T2-N0 cancers of the oral cavity | Other | Procedure: outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node searchoutpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node searchThe 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. | Procedure or surgery | T1-N0 or T2-N0 cancers of the oral cavity |
Primary outcome
Conversion rate in complete hospitalization or re-hospitalization within 10 days following the surgical procedure (D0)
Time frame: From Day 0 to 10 days post surgery
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
7 secondary outcomes
Acceptance rate of outpatient surgery
Time frame: inclusion visit
Description of complications attributable to outpatient care taken on Day 0, Day 10 and Month1
Time frame: From Day 0 to Month 1 post surgery
Quality of life at inclusion visit
Time frame: Inclusion visit
Quality of life at Day 0 visit
Time frame: Day 0 visit
Quality of life at Day 10 post surgery
Time frame: Day 10 visit post surgery
Quality of life at month 1 post surgery
Time frame: Month 1 visit post surgery
Evaluation of the cost of the strategy at Month 1
Time frame: Month 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Results publication: PubMed 20304284Burcia 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.
- Results publication: PubMed 27842990Garrel 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.
- Results publication: PubMed 26597442Schilling 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.
- Results publication: PubMed 22035652Lee 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Renaud GARREL, ENT principal investigator
CHU Montpellier Gui de Chauliac Hospital, Neuroscience Head and Neck Pole, ENT Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search in people with Cancer T1-N0 or T2-N0 of the Oral Cavity, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renaud GARREL, ENT (+33 467-336-920, r-garrel@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate in complete hospitalization or re-hospitalization within 10 days following the surgical procedure (D0) (time frame: From Day 0 to 10 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03545256, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.