Head and Neck TumorsSentiMERORLNCT02855723
Randomized, Open-label Economic and Medical Study on the Lymph Node Management of Squamous Cell Carcinoma of the Oral Cavity and Oropharynx Tumor Stage 1 or 2, Nodes 0 (T1-T2 N0) Operable
A study testing Surgery: GS strategy and Surgery: Classic strategy in people with Head and Neck Tumors, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Currently, patients with cancer of oral cavity or oropharynx T1-T2N0 classified, are treated surgically with systematic lymph node dissection while in 70%, there is no lymph node metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Tumors
- What is being tested?
- Surgery: GS strategy and Surgery: Classic strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2008to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Man or woman age over 18 without upper age limit
- Social Insured
- Patient Information and Informed Consent signed by the patient
- Patient not participating in another trial since the legal time
- Absence of any previous treatment for cancer of the Upper AeroDigestive Tract (VADS)
- Patient with primary squamous cell carcinoma of the oral cavity or oropharynx documented by biopsy with histopathologic analysis not older than 1 month
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- curable or operable tumor with radiation under the Tumor, Nodes, Metastasis (TNM) stage, location and the patient's general condition
- Stage T1 and T2
- Tumor listed N0 satisfying the following conditions (21 days validity period): A) absence of lymphadenopathy palpable on clinical examination of the ENT investigator. B) CT scan or MRI with injection of contrast product: lack of suspicious adenomegaly for metastasis = node size less than one centimeter and 1.5 cm for the group IIa, ovoid, homogeneous, not taking contrast and showing no signs of lymph perinodal invasion ( hyperdensity fat, vascular adhesion), absence of lymph node group (> 3)
- Systematic ENT endoscopy eliminating a second synchronous tumor and precisely establishing the T (21 days validity period)
- Absence of metastasis: M0
Who cannot join
- Failure of one of the inclusion criteria
- Other cancer being treated
- Non-invasive tumor: high-grade dysplasia, carcinoma in situ
- Inadequate tumor excision: margins invaded without further recovery in safe zone
- Contraindications to surgery such sentinel node or lymph node dissection
- Contraindications to radiotherapy
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- Contraindications to performing a scan:
- Known allergy or intolerance to the injected product and particularly with Technetium-99
- Pregnancy
- Refusal to accept the full treatment regardless of the strategy
- Follow-up not possible
- Refusal to accept the described follow-up and / or provide the necessary information for the study
- Patient already treated for the tumor outside an excision biopsy
- Patient who previously had chemotherapy or immunotherapy for another cancer outside VADS within less than 6 months
- Patient undergoing cervical or VADS radiotherapy whatever the cause or time
- Patient who have had cervical spine surgery regardless of the cause or time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open-label Economic and Medical Study on the Lymph Node Management of Squamous Cell Carcinoma of the Oral Cavity and Oropharynx T1-T2N0 Operable : Comparison of the Reference Strategy Based on a the Systematic Lymph Node Dissection Versus the Strategy Based on the Technique of Sentinel Lymph Node.
Currently, patients with cancer of oral cavity or oropharynx T1-T2N0 classified, are treated surgically with systematic lymph node dissection while in 70%, there is no lymph node metastasis. The technique of identifying the sentinel node (GS) is validated for these tumors because the status of the sentinel node is predictive of the other nodes status in the neck. This helps to diagnose the presence of metastases without lymph node dissection and thus select patients requiring a treatment node. However, the oncological and functional results of a therapeutic strategy based on identifying the GS is unknown.
This open-label randomized multicenter clinical trial aims to compare the oncologic and functional outcome of two strategies : the current management versus the management based on the sentinel lymph node.
Read more
The hypothesis is based on a nodal control difference at 2 years in both arms not exceeding 10%. The medico-economic analysis will be conducted in two stages : a classic stage on 2 years with estimated incremental cost-effectiveness and incremental cost-utility, then a step with log term modeling.
A reduction in morbidity and treatment costs in the sentinel node arm are expected in this study.
Read the detailed description
This study schedules the screening visit (V0) and then 9 follow-up visits during 24 months.
At the screening, after verification of the eligibility criteria and signature of the informed consent form, the subject will be randomized in one of 2 arms. At the inclusion the following exams have to be done : clinical exam, panendoscopy, cytologic and histologic analysis and CT-Scan (or MRI). For each visit, the investigator will perform a clinical exam and the subjects should complete some questionnaires themselves from V0 to V3, V6 (12 months) and V9. At the last visit (24 months) the patients will have a CTC-Scan ou MRI.
At the end of the follow-up period (24 months), the data of subjects survival will be recorded during three years.
- Conditions
- Head and Neck Tumors
- Being tested
- Surgery: GS strategy, Surgery: Classic strategy
- Keywords
- Squamous carcinoma of oral cavity and oropharynx, Sentinel lymph node, Lymph node dissection, Equivalence
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery: GS strategyOther
sentinel node biopsy
Surgery: Classic strategyOther
systematic lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| GS strategy | Active comparator | sentinel node biopsy Receives: Other: Surgery: GS strategy |
| Classic strategy | Other | systematic lymphadenectomy Receives: Other: Surgery: Classic strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nodal recurrence rate
The absence of recurrence at 2 years will be affirmed by the absence of clinical signs confirmed by a medical imaging exam.
Measured: 24 months after the surgery
Secondary outcomes (5)
Evaluation of quality of life with Head and Neck 35 (H&N35)
Evaluate quality of life on the two years of the follow up
Measured: At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery
Evaluation of the costs
The costs will be collected Under usual forms as the direct, indirect and intangible costs, directly to the relevant services and patients themselves
Measured: At the inclusion, and at 2, 4, 6, 8, 10, 12 16, 20 and 24 months after the surgery
Evaluation of quality of life with Quality of Life Questionnaire Core 30 (QLQ-C30)
Evaluate quality of life on the two years of the follow up
Measured: At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery
Evaluation of quality of life with EuroQOL 5D (EQ 5D)
Evaluate quality of life on the two years of the follow up
Measured: At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery
Evaluation of quality of life with Short Form 36 (SF36))
Evaluate quality of life on the two years of the follow up
Measured: At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startApr 2008
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck TumorsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855723
- Sponsor's protocol ID
- UF 5023
- Other IDs
- 2007- AO1191-52
- Acronym
- SentiMERORL
- Status last verified
- Jul 2016
- First submitted
- 19 Jul 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Garrel R, Poissonnet G, Moya Plana A, Fakhry N, Dolivet G, Lallemant B, Sarini J, Vergez S, Guelfucci B, Choussy O, Bastit V, Richard F, Costes V, Landais P, Perriard F, Daures JP, de Verbizier D, Favier V, de Boutray M. Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer. J Clin Oncol. 2020 Dec 1;38(34):4010-4018. doi: 10.1200/JCO.20.01661. Epub 2020 Oct 14.
PubMed 33052754
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label Economic and Medical Study on the Lymph Node Management of Squamous Cell Carcinoma of the Oral Cavity and Oropharynx T1-T2N0 Operable : Comparison of the Reference Strategy Based on a the Systematic Lymph Node Dissection Versus the Strategy Based on the Technique of Sentinel Lymph Node.
- ClinicalTrials.gov ID
- NCT02855723
- Acronym / sponsor ID
- SentiMERORL / UF 5023
- Conditions
- Head and Neck Tumors
- Keywords
- Squamous carcinoma of oral cavity and oropharynx, Sentinel lymph node, Lymph node dissection, Equivalence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Aug 2016 (estimated)
- 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.
Currently, patients with cancer of oral cavity or oropharynx T1-T2N0 classified, are treated surgically with systematic lymph node dissection while in 70%, there is no lymph node metastasis. The technique of identifying the sentinel node (GS) is validated for these tumors because the status of the sentinel node is predictive of the other nodes status in the neck. This helps to diagnose the presence of metastases without lymph node dissection and thus select patients requiring a treatment node. However, the oncological and functional results of a therapeutic strategy based on identifying the GS is unknown.
This open-label randomized multicenter clinical trial aims to compare the oncologic and functional outcome of two strategies : the current management versus the management based on the sentinel lymph node.
The hypothesis is based on a nodal control difference at 2 years in both arms not exceeding 10%. The medico-economic analysis will be conducted in two stages : a classic stage on 2 years with estimated incremental cost-effectiveness and incremental cost-utility, then a step with log term modeling.
A reduction in morbidity and treatment costs in the sentinel node arm are expected in this study.
Detailed description
This study schedules the screening visit (V0) and then 9 follow-up visits during 24 months.
At the screening, after verification of the eligibility criteria and signature of the informed consent form, the subject will be randomized in one of 2 arms. At the inclusion the following exams have to be done : clinical exam, panendoscopy, cytologic and histologic analysis and CT-Scan (or MRI). For each visit, the investigator will perform a clinical exam and the subjects should complete some questionnaires themselves from V0 to V3, V6 (12 months) and V9. At the last visit (24 months) the patients will have a CTC-Scan ou MRI.
At the end of the follow-up period (24 months), the data of subjects survival will be recorded during three years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GS strategy | Active comparator | Other: Surgery: GS strategysentinel node biopsy |
| Classic strategy | Other | Other: Surgery: Classic strategysystematic lymphadenectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Man or woman age over 18 without upper age limit
- Social Insured
- Patient Information and Informed Consent signed by the patient
- Patient not participating in another trial since the legal time
- Absence of any previous treatment for cancer of the Upper AeroDigestive Tract (VADS)
Key exclusion criteria (16 listed)
- Failure of one of the inclusion criteria
- Other cancer being treated
- Non-invasive tumor: high-grade dysplasia, carcinoma in situ
- Inadequate tumor excision: margins invaded without further recovery in safe zone
- Contraindications to surgery such sentinel node or lymph node 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 |
|---|---|---|
| Surgery: GS strategysentinel node biopsy | Other | GS strategy |
| Surgery: Classic strategysystematic lymphadenectomy | Other | Classic strategy |
Primary outcome
Nodal recurrence rate
Time frame: 24 months after the surgery
The absence of recurrence at 2 years will be affirmed by the absence of clinical signs confirmed by a medical imaging exam.
5 secondary outcomes
Evaluation of quality of life with Head and Neck 35 (H&N35)
Time frame: At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery
Evaluation of the costs
Time frame: At the inclusion, and at 2, 4, 6, 8, 10, 12 16, 20 and 24 months after the surgery
Evaluation of quality of life with Quality of Life Questionnaire Core 30 (QLQ-C30)
Time frame: At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery
Evaluation of quality of life with EuroQOL 5D (EQ 5D)
Time frame: At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery
Evaluation of quality of life with Short Form 36 (SF36))
Time frame: At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Derived from this study: PubMed 33052754Garrel R, Poissonnet G, Moya Plana A, Fakhry N, Dolivet G, Lallemant B, Sarini J, Vergez S, Guelfucci B, Choussy O, Bastit V, Richard F, Costes V, Landais P, Perriard F, Daures JP, de Verbizier D, Favier V, de Boutray M. Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer. J Clin Oncol. 2020 Dec 1;38(34):4010-4018. doi: 10.1200/JCO.20.01661. Epub 2020 Oct 14.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery: GS strategy and Surgery: Classic strategy in people with Head and Neck Tumors, 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 11 inclusion and 16 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: finished, as of the sponsor's last update on 4 Aug 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nodal recurrence rate (time frame: 24 months after the 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 NCT02855723, which also lists 1 linked publication.
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 4 Aug 2016.