Cancer of Head and NeckPhase 2RoboCUPNCT04767048
Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy
A Phase 2 study testing bilateral mucosectomy + tonsillectomy and tonsillectomy in people with Cancer of Head and Neck and Adenopathy, run by Centre Francois Baclesse at 5 sites in France.
Trial summary
We are proposing a randomized phase II study to assess the benefit of bilateral robot-assisted or laser basal tongue mucosectomy in combination with tonsillectomy in the assessment of prevalent cervical lymphadenopathy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck, Adenopathy
- What is being tested?
- bilateral mucosectomy + tonsillectomy and tonsillectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 5 sitesFrance
- Study dates
- 30 Jun 2021to Mar 2029
- Phase
- Phase 2
- 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
- Patient with a prevalent head and neck lymphadenopathy with positive or non-contributory fine needle aspiration, or having had an adenectomy revealing a metastasis of squamous cell carcinoma, a PET examination, an injected cervico-thoracic CT and an ENT work-up (nasofibroscopy) not finding a primary tumor
- Performance Status < 2
- Patient aged 18 or over
- Patient affiliated with social security system
- Informed consent signed
Who cannot join
- History of squamous cell carcinoma of the VADS or skin of the face.
- History of cervico-facial radiotherapy
- Primary tumor discovering during pan-endoscopy
- Inexposable patient lead not to possible mucosectomy
- Uncontrollable hemostasis disorders (contraindication to tonsillectomy and basic bilateral mucosectomy of language)
- Distant metastases
Show all 12Show fewer
- Lymphadenopathy inoperable
- Patient with a contraindication to radiotherapy
- Pregnant or breastfeeding woman
- Women of childbearing potential without effective contraception
- Patient under guardianship or unable to give informed consent
- Patient unable to undergo the trial follow-up for geographic, social or psychopathological reasons
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Centre François Baclesse
Caen
LASNE CARDON Audrey, MD, a.lasne-cardon@baclesse.unicancer.fr
- Recruiting
CHU CAEN
Caen
Maxime HUMBERT, MD
- Recruiting
Centre Oscar Lambret
Lille
Samia BOUHIR, MD
- Recruiting
Chru Lille
Lille
Francois Mouawad, MD
- Recruiting
CHU Rouen
Rouen
Sophie DENEUVE, MD
About this study
Official title: Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy: a Randomized Phase II Study
We are proposing a randomized phase II study to assess the benefit of bilateral robot-assisted or laser basal tongue mucosectomy in combination with tonsillectomy in the assessment of prevalent cervical lymphadenopathy
- Conditions
- Cancer of Head and Neck, Adenopathy
- Being tested
- bilateral mucosectomy + tonsillectomy, tonsillectomy
- Keywords
- mucosectomy, tonsil
- Medical subject headings
- Head and Neck Neoplasms, Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral mucosectomy + tonsillectomyProcedure or surgery
Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)
tonsillectomyProcedure or surgery
tonsillectomy (unilateral or bilateral at the choice of the investigator)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator) Receives: Procedure: bilateral mucosectomy + tonsillectomy |
| Control Arm | Active comparator | Tonsillectomy alone (unilateral or bilateral at the choice of the investigator) Receives: Procedure: tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of primary cancer
Proportion of patients with primary cancer detected with surgery
Measured: At surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start30 Jun 2021
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
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 Cancer of Head and NeckStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767048
- Sponsor's protocol ID
- 2020-A00947-32
- Acronym
- RoboCUP
- Status last verified
- Oct 2024
- First submitted
- 19 Feb 2021
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bastit V, Lequesne J, Leconte A, Deneuve S, Mouawad F, Quak E, Jeanne C, Clarisse B, Thariat J. Effectiveness of bilateral tongue base mucosectomy by transoral robotic surgery or transoral laser microsurgery in combination with tonsillectomy in identifying head and neck primary cancer of unknown primary: a randomized phase 2 protocol (RoboCUP trial). BMC Cancer. 2025 Mar 27;25(1):551. doi: 10.1186/s12885-025-13913-7.
PubMed 40148848
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy: a Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT04767048
- Acronym / sponsor ID
- RoboCUP / 2020-A00947-32
- Conditions
- Cancer of Head and Neck, Adenopathy
- Keywords
- mucosectomy, tonsil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 23 Feb 2021 (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.
We are proposing a randomized phase II study to assess the benefit of bilateral robot-assisted or laser basal tongue mucosectomy in combination with tonsillectomy in the assessment of prevalent cervical lymphadenopathy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Procedure: bilateral mucosectomy + tonsillectomyBasic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator) |
| Control Arm | Active comparator | Procedure: tonsillectomyTonsillectomy alone (unilateral or bilateral at the choice of the investigator) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with a prevalent head and neck lymphadenopathy with positive or non-contributory fine needle aspiration, or having had an adenectomy revealing a metastasis of squamous cell carcinoma, a PET examination, an injected cervico-thoracic CT and an ENT work-up (nasofibroscopy) not finding a primary tumor
- Performance Status < 2
- Patient aged 18 or over
- Patient affiliated with social security system
- Informed consent signed
Key exclusion criteria (12 listed)
- History of squamous cell carcinoma of the VADS or skin of the face.
- History of cervico-facial radiotherapy
- Primary tumor discovering during pan-endoscopy
- Inexposable patient lead not to possible mucosectomy
- Uncontrollable hemostasis disorders (contraindication to tonsillectomy and basic bilateral mucosectomy of language)
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 |
|---|---|---|
| bilateral mucosectomy + tonsillectomyBasic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator) | Procedure or surgery | Experimental Arm |
| tonsillectomytonsillectomy (unilateral or bilateral at the choice of the investigator) | Procedure or surgery | Control Arm |
Primary outcome
Detection of primary cancer
Time frame: At surgery
Proportion of patients with primary cancer detected with surgery
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 15 Oct 2024.
- Derived from this study: PubMed 40148848Bastit V, Lequesne J, Leconte A, Deneuve S, Mouawad F, Quak E, Jeanne C, Clarisse B, Thariat J. Effectiveness of bilateral tongue base mucosectomy by transoral robotic surgery or transoral laser microsurgery in combination with tonsillectomy in identifying head and neck primary cancer of unknown primary: a randomized phase 2 protocol (RoboCUP trial). BMC Cancer. 2025 Mar 27;25(1):551. doi: 10.1186/s12885-025-13913-7.
- Individual participant dataSharing planned: No
Related trials for Cancer of Head and Neck
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bilateral mucosectomy + tonsillectomy and tonsillectomy in people with Cancer of Head and Neck and Adenopathy, run by Centre Francois Baclesse at 5 sites 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 5 inclusion and 12 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Vianney BASTIT, MD (33231455050, v.bastit@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of primary cancer (time frame: At 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 NCT04767048, 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 15 Oct 2024.