Oropharyngeal Squamous Cell CarcinomaSELECT-FRNCT07241273
SPECT-CT Guided ELEctive Contralateral Neck Treatment in Lateralized Oropharyngeal Cancer
A study testing Lymphatic mapping with SPECT-CT, Bilateral neck radiotherapy and Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy in people with Oropharyngeal Squamous Cell Carcinoma and Oropharyngeal Cancers, run by UNICANCER at 12 sites in France.
Trial summary
Oropharyngeal cancer (OPC) is the most common type of head and neck cancer. The current standard treatment for this cancer is radiotherapy (RT) of the tumour and lymph nodes of both sides of the neck, combined with concurrent chemotherapy for advanced stages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Cancers, Oropharyngeal Carcinoma
- What is being tested?
- Lymphatic mapping with SPECT-CT, Bilateral neck radiotherapy and Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 12 sitesFrance
- Study dates
- Sep 2026to Sep 2031
- 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
- Patients must have signed a written informed consent form prior to any trial specific procedures.
- Patients with histologically confirmed T1-T3 M0 lateralized OPC (tonsil, soft palate, pharyngeal wall or base of tongue) not involving or crossing midline. Nodal disease may include no node or single or multiple ipsilateral lymph nodes (largest should be equal or less than 6 cm in maximum diameter) without contralateral nodes involved. For HPV-positive patients, this includes N0-N1. For HPV-negative patients, this includes N0-N2b. Patients with radiologic extranodal extension without clinical signs of extranodal extension (skin invasion, deep nodal fixation, and/or clinical signs of cranial nerve or brachial plexus invasion) will be eligible for participation.
- HPV-positive or -negative (by p16 immunohistochemistry). Tumours will be classified as p16 at local sites based on greater than 70% strong diffuse nuclear or nuclear and cytoplasmic staining.
- Planned definitive bilateral neck radiotherapy with or without concurrent chemotherapy.
- Patients ≥ 18 years old.
- ECOG Performance Status 0-1.
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- The following radiological investigations must have been done within 8 weeks before randomization:
- CT or MRI of the neck (with head imaging as indicated);
- PET-CT scan;
- Chest CT scan.
- Patients who receive a concomitant chemoradiotherapy (cCRT) should have adequate organ and bone marrow function including the following:
- Hematological function (absolute neutrophil count ≥ 1.5 x10⁹/L, platelets ≥ 100 x10⁹/L, hemoglobin ≥ 9 g/dL) measured before cCRT.
- Renal function (creatinine clearance ≥ 50 mL/min per Cockcroft and Gault formula) measured before cCRT.
- Hepatic function (total bilirubin < 1.5 ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2.5 ULN, Alkaline phosphatase < 2.5 ULN) measured before cCRT.
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method up to 90 days after completing radiotherapy.
- Women of childbearing potential must have a negative pregnancy test before the beginning of the trial.
- Treating surgeon must confirm that the patient is a candidate to undergo injection procedure for lymphatic mapping in either the nuclear medicine, ambulatory clinic, or operating room setting.
- Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
- Patients affiliated to (or beneficiary from) the French social security system.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Who cannot join
- Patients with T1-T2 cancers isolated to the tonsil fossa (i.e., without any soft palate, tongue base, posterior pharyngeal wall or posterior tonsil pillar involvement) with no involved lymph nodes or with a single ipsilateral node < 3 cm without extranodal extension.
- Patients with tonsil or tongue base primary squamous cell carcinoma who have previously undergone diagnostic palatine or lingual tonsillectomy with either complete excision or with no clinically apparent residual disease are excluded. However, patients who have had previous deep biopsies or partial excisions with clinically evaluable disease are still eligible.
- Previous head and neck cancer or multiple synchronous primary head and neck cancers.
- Previous induction or neo-adjuvant chemotherapy.
- Previous radiation therapy to the head and neck or comprehensive neck dissection of at least 3 levels on either side (due to potential for disrupted lymphatic channels and drainage pathways). Patients who have had excisional biopsies of involved lymph nodes are, however, still eligible.
- Previous radiotracer allergy. Contraindication in patients with history of hypersensitivity to human albumin-containing products.
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- Patients with severe, active co-morbidity including any of the following:
- Chronic Obstructive Pulmonary Disease or other pulmonary illness requiring hospitalization within 30 days of registration.
- Unstable angina and/or congestive heart failure requiring hospitalization within the 30 days of registration.
- Acute myocardial infarction within 30 days of study registration.
- Diseases precluding RT (e.g., scleroderma).
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, as assessed by the investigator.
- Pregnant or breastfeeding women.
- Patient enrolled in another therapeutic trial within 30 days of registration.
- Persons deprived of their liberty or under protective custody or guardianship.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites
CHU Brest
Brest
Ulrike SCHICK, MD
Centre François Baclesse
Caen
Juliette THARIAT, MD
CHU Caen
Caen
Emmanuel BABIN, MD
Centre Georges François Leclerc
Dijon
Noémie VULQUIN, MD
Centre de Radiothérapie Guillaume Le Conquérant
Le Havre
Laurent MARTIN, MD
Centre Oscar Lambret
Lille
Xavier LIEM, MD
Institut Régional du Cancer de Montpellier
Montpellier
Pierre BOISSELIER, MD
Hôpital Tenon
Paris
Florence HUGUET, MD
Centre Henri Becquerel
Rouen
Sébastien THUREAU, MD
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg
Philippe SCHULTZ, MD
Institut de Cancérologie Strasbourg Europe
Strasbourg
Jordan EBER, MD
CHRU Tours - Hôpital Bretonneau
Tours
Sofia BAKKAR, MD
About this study
Official title: SPECT-CT Guided ELEctive Contralateral Neck Treatment in Lateralized Oropharyngeal Cancer: A Phase II Trial
Oropharyngeal cancer (OPC) is the most common type of head and neck cancer. The current standard treatment for this cancer is radiotherapy (RT) of the tumour and lymph nodes of both sides of the neck, combined with concurrent chemotherapy for advanced stages. Even though a small proportion of patients with this cancer have involvement of the lymph nodes of the neck on the opposite side of the tumour (contralateral involvement) or involvement of the lymph nodes on both sides of the neck (bilateral involvement), bilateral radiotherapy is performed due to the risk of contralateral microscopic involvement, which is invisible on imaging and clinical examination. Bilateral radiotherapy causes more adverse events, leading to a decrease in quality of life.
Lymphatic mapping using Single Photon Emission Computed Tomography-Computed Tomography (SPECT-CT) imaging is a technique that visualises the lymphatic drainage of the tumour and thus determines whether radiotherapy should be delivered unilaterally or bilaterally to the lymph nodes. This technique would therefore reduce adverse events and improve quality of life, while maintaining the efficacy of radiotherapy.
The goal of the clinical trial SELECT-FR is to investigate if the efficacy of a lymphatic drainage mapping with a SPECT-CT-guided approach is acceptable in terms of two-year Disease Free Survival (DFS) rate in patients with lateralized OPC.
Read the detailed description
SELECT-FR is a national, randomized, phase II, non-comparative trial.
Patients aged 18 or over, with lateralized oropharyngeal squamous cell carcinoma (tonsil, soft palate, pharyngeal wall or tongue base) not involving or crossing midline, Human Papilloma Virus (HPV) positive or negative, T1-T3 with no contralateral nodes or nodes > 6 cm on Computed Tomography (CT), Magnetic Resonance Imaging (MRI) or Positron Emission Tomography-Computed Tomography (PET-CT).
Eligible subjects will be randomized at a 1:1 ratio into the experimental and control arms.
- Experimental arm: Patients will receive definitive RT to the primary tumour and ipsilateral neck nodes, while contralateral neck RT treatment will be guided by lymphatic mapping with SPECT-CT.
- Control arm: Patients will receive definitive RT to the primary tumour and bilateral neck nodes (Note: candidates for standard unilateral neck RT are not eligible).
Randomization will be stratified by the following factors:
- Anatomical location of primary tumour: lateral vs. intermediate vs. medial.
- HPV status (p16 immunohistochemistry) and smoking status: p16 positive ≤ 10 pack year vs. p16 positive > 10 pack year vs. p16 negative any.
- Extent of disease: limited vs. other:
- p16 positive: limited [T1-T2, N0-N1 (single node < 3cm without radiologic extranodal extension)] vs. other.
- p16 negative: limited [T1-T2, N0-N1 (without radiologic extranodal extension)] vs. other.
- Use of concurrent systemic therapy: yes vs. no.
In both arms, time from randomization to initiation of RT will be no longer than 6 weeks. Patients will receive RT with or without standard concurrent chemotherapy in either standard fractionation (7 weeks) or altered fractionation (6 weeks).
In both arms, all patients will be followed by local investigator as follow:
- Treatment period: every week.
- Follow-up period: every 3 months until 24 months after treatment and then every 6 months until 36 months after treatment.
- Conditions
- Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Cancers, Oropharyngeal Carcinoma, Head and Neck, Head and Neck Cancer, Head and Neck Cancers
- Being tested
- Lymphatic mapping with SPECT-CT, Bilateral neck radiotherapy, Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphatic mapping with SPECT-CTOther
Lymphatic mapping with SPECT-CT
Bilateral neck radiotherapyRadiation
Patients will receive definitive radiotherapy to the primary tumour and bilateral neck nodes.
Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapyRadiation
Patients will receive definitive radiotherapy to the primary tumour and ipsilateral neck nodes while radiotherapy to the contralateral neck nodes will be guided by lymphatic mapping with SPECT-CT.
| Study group | Role | What they receive |
|---|---|---|
| Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy | Experimental | Radiotherapy of ipsilateral neck nodes \& Radiotherapy of the contralateral neck nodes guided by SPECT-CT Receives: Other: Lymphatic mapping with SPECT-CT; Radiation: Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy |
| Bilateral neck radiotherapy | Active comparator | Radiotherapy of nodes on both sides of the neck Receives: Radiation: Bilateral neck radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-years Disease Free Survival (DFS) rate
The primary endpoint is 2 year-Disease-Free Survival rate (2y-DFS) defined as patients free of disease at two years. Patients without any event before 2 years will be considered as success, patients lost to follow-up before 2 years will be considered as failure.
Measured: At 2 years after treatment
Secondary outcomes (8)
Disease free survival
Disease-free survival (DFS) is defined as time from randomization to the date of first record of any of the following events including local, regional, or distant recurrence or death from any cause. DFS will be censored on the date of last visit with disease assessment.
Measured: From randomization to any of the following events: local, regional, or distant recurrence or death from any cause, up to 3 years after treatment.
Overall survival (OS)
Overall survival (OS) is defined as the time from the date of randomization to the date of death from any cause. The follow-up of subjects still alive will be censored at the date of last visit/contact.
Measured: From randomization to the date of death from any cause, up to 3 years after treatment.
Isolated Contralateral Neck Failure (iCNF)
Isolated Contralateral Neck Failure (iCNF) is defined as the time from the date of randomization to the date of iCNF. Local ipsilateral neck failure, or distant failure diagnosed concurrently with iCNF or before are not considered events of interest but as competing risks events in the analysis of this endpoint. Subjects without any of the listed events (i.e. events of interest or competing risks events) are censored at the date of the most recent follow-up examination.
Measured: From randomization to the date of iCNF, up to 3 years after treatment.
Local-regional failure (LRF)
Local-regional failure (LRF) is defined as the time from the date of randomization to the date of any local or regional failure. Distant recurrence/progression diagnosed before local or regional failure are not considered events of interest, but as competing risks events in the analysis of this endpoint. Subjects without any of the listed events (i.e. events of interest or competing risks events) are censored at the date of the most recent follow-up examination.
Measured: From randomization to the date of any local or regional failure, up to 3 years after treatment.
Distant metastases (DM)
Distant metastases (DM) are defined as clear evidence of distant metastases in the lung, bone, brain, liver or other distant sites. Biopsy is recommended where possible according to local practices. Distant sites can be evaluated by CT scans or PET-CT. Distant metastasis free survival is defined as the time from the date of randomization to the date of distant metastases. All other events are not considered events of interest, but as competing risks events in the analysis of this endpoint.
Measured: From randomization until clear evidence of distant metastasis, up to 3 years after treatment.
Incidence and Severity of Treatment-Related Adverse Events
Toxicities will be measured using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.0). The NCI-CTCAE is a descriptive terminology which can be used for Adverse Event (AE) reporting and it is widely accepted in the community of oncology research as the leading rating scale for adverse events. A grading (severity) scale is provided for each AE term. This scale is divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death"). Toxicities will be measured by the investigator weekly during Radiotherapy (RT), at 1 month and 3 months after completion of RT to assess acute toxicities and then at each follow up visit following completion of RT to assess late toxicities until 36 months post RT.
Measured: Throughout study completion, up to 3 years after treatment.
Incidence and Severity of Treatment-Related Adverse Events reported by patients (using items of PRO-CTCAE)
Patient reported toxicities will be evaluated using selected items of the validated Patient-Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE). It is recognized that clinician-reported adverse events (AEs) may substantially under-report the incidence and severity of symptoms occurring as a consequence of treatment. In response to this awareness, the NCI has developed a set of patient-reported items (called PRO-CTCAE) that complement the CTCAE and capture the patient's perspective on the subjective aspects of adverse events. PRO-CTCAE H\&N information will complement the clinician CTCAE reporting. A collection of 15 specific PRO-CTCAE Head \& Neck (H\&N) items is proposed. Patient reported toxicities will be evaluated at baseline, end of treatment, 12, and 24 months after the end of treatment.
Measured: Throughout study completion, up to 2 years after treatment.
Gastrostomy tube usage
Gastrostomy tube usage will be assessed for the presence of a gastrostomy tube as well as usage of the gastrostomy tube at each visit until tube removal.
Measured: Throughout study completion, up to 3 years after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study startSep 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by UNICANCERThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Sébastien THUREAU, MD, Study chair, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241273
- Sponsor's protocol ID
- UC-RAD-2506
- Other IDs
- 2025-A00913-46
- Acronym
- SELECT-FR
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECT-CT Guided ELEctive Contralateral Neck Treatment in Lateralized Oropharyngeal Cancer: A Phase II Trial
- ClinicalTrials.gov ID
- NCT07241273
- Acronym / sponsor ID
- SELECT-FR / UC-RAD-2506
- Conditions
- Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Cancers, Oropharyngeal Carcinoma, Head and Neck, Head and Neck Cancer, Head and Neck Cancers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 21 Nov 2025 (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.
Oropharyngeal cancer (OPC) is the most common type of head and neck cancer. The current standard treatment for this cancer is radiotherapy (RT) of the tumour and lymph nodes of both sides of the neck, combined with concurrent chemotherapy for advanced stages. Even though a small proportion of patients with this cancer have involvement of the lymph nodes of the neck on the opposite side of the tumour (contralateral involvement) or involvement of the lymph nodes on both sides of the neck (bilateral involvement), bilateral radiotherapy is performed due to the risk of contralateral microscopic involvement, which is invisible on imaging and clinical examination. Bilateral radiotherapy causes more adverse events, leading to a decrease in quality of life.
Lymphatic mapping using Single Photon Emission Computed Tomography-Computed Tomography (SPECT-CT) imaging is a technique that visualises the lymphatic drainage of the tumour and thus determines whether radiotherapy should be delivered unilaterally or bilaterally to the lymph nodes. This technique would therefore reduce adverse events and improve quality of life, while maintaining the efficacy of radiotherapy.
The goal of the clinical trial SELECT-FR is to investigate if the efficacy of a lymphatic drainage mapping with a SPECT-CT-guided approach is acceptable in terms of two-year Disease Free Survival (DFS) rate in patients with lateralized OPC.
Detailed description
SELECT-FR is a national, randomized, phase II, non-comparative trial.
Patients aged 18 or over, with lateralized oropharyngeal squamous cell carcinoma (tonsil, soft palate, pharyngeal wall or tongue base) not involving or crossing midline, Human Papilloma Virus (HPV) positive or negative, T1-T3 with no contralateral nodes or nodes > 6 cm on Computed Tomography (CT), Magnetic Resonance Imaging (MRI) or Positron Emission Tomography-Computed Tomography (PET-CT).
Eligible subjects will be randomized at a 1:1 ratio into the experimental and control arms.
- Experimental arm: Patients will receive definitive RT to the primary tumour and ipsilateral neck nodes, while contralateral neck RT treatment will be guided by lymphatic mapping with SPECT-CT.
- Control arm: Patients will receive definitive RT to the primary tumour and bilateral neck nodes (Note: candidates for standard unilateral neck RT are not eligible).
Randomization will be stratified by the following factors:
- Anatomical location of primary tumour: lateral vs. intermediate vs. medial.
- HPV status (p16 immunohistochemistry) and smoking status: p16 positive ≤ 10 pack year vs. p16 positive > 10 pack year vs. p16 negative any.
- Extent of disease: limited vs. other:
- p16 positive: limited [T1-T2, N0-N1 (single node < 3cm without radiologic extranodal extension)] vs. other.
- p16 negative: limited [T1-T2, N0-N1 (without radiologic extranodal extension)] vs. other.
- Use of concurrent systemic therapy: yes vs. no.
In both arms, time from randomization to initiation of RT will be no longer than 6 weeks. Patients will receive RT with or without standard concurrent chemotherapy in either standard fractionation (7 weeks) or altered fractionation (6 weeks).
In both arms, all patients will be followed by local investigator as follow:
- Treatment period: every week.
- Follow-up period: every 3 months until 24 months after treatment and then every 6 months until 36 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy | Experimental | Other: Lymphatic mapping with SPECT-CT, Radiation: Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapyRadiotherapy of ipsilateral neck nodes \& Radiotherapy of the contralateral neck nodes guided by SPECT-CT |
| Bilateral neck radiotherapy | Active comparator | Radiation: Bilateral neck radiotherapyRadiotherapy of nodes on both sides of the neck |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients must have signed a written informed consent form prior to any trial specific procedures.
- Patients with histologically confirmed T1-T3 M0 lateralized OPC (tonsil, soft palate, pharyngeal wall or base of tongue) not involving or crossing midline. Nodal disease may include no node or single or multiple ipsilateral lymph nodes (largest should be equal or less than 6 cm in maximum diameter) without contralateral nodes involved. For HPV-positive patients, this includes N0-N1. For HPV-negative patients, this includes N0-N2b. Patients with radiologic extranodal extension without clinical signs of extranodal extension (skin invasion, deep nodal fixation, and/or clinical signs of cranial nerve or brachial plexus invasion) will be eligible for participation.
- HPV-positive or -negative (by p16 immunohistochemistry). Tumours will be classified as p16 at local sites based on greater than 70% strong diffuse nuclear or nuclear and cytoplasmic staining.
- Planned definitive bilateral neck radiotherapy with or without concurrent chemotherapy.
- Patients ≥ 18 years old.
Key exclusion criteria (15 listed)
- Patients with T1-T2 cancers isolated to the tonsil fossa (i.e., without any soft palate, tongue base, posterior pharyngeal wall or posterior tonsil pillar involvement) with no involved lymph nodes or with a single ipsilateral node < 3 cm without extranodal extension.
- Patients with tonsil or tongue base primary squamous cell carcinoma who have previously undergone diagnostic palatine or lingual tonsillectomy with either complete excision or with no clinically apparent residual disease are excluded. However, patients who have had previous deep biopsies or partial excisions with clinically evaluable disease are still eligible.
- Previous head and neck cancer or multiple synchronous primary head and neck cancers.
- Previous induction or neo-adjuvant chemotherapy.
- Previous radiation therapy to the head and neck or comprehensive neck dissection of at least 3 levels on either side (due to potential for disrupted lymphatic channels and drainage pathways). Patients who have had excisional biopsies of involved lymph nodes are, however, still eligible.
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 |
|---|---|---|
| Lymphatic mapping with SPECT-CTLymphatic mapping with SPECT-CT | Other | Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy |
| Bilateral neck radiotherapyPatients will receive definitive radiotherapy to the primary tumour and bilateral neck nodes. | Radiation | Bilateral neck radiotherapy |
| Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapyPatients will receive definitive radiotherapy to the primary tumour and ipsilateral neck nodes while radiotherapy to the contralateral neck nodes will be guided by lymphatic mapping with SPECT-CT. | Radiation | Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy |
Primary outcome
Two-years Disease Free Survival (DFS) rate
Time frame: At 2 years after treatment
The primary endpoint is 2 year-Disease-Free Survival rate (2y-DFS) defined as patients free of disease at two years. Patients without any event before 2 years will be considered as success, patients lost to follow-up before 2 years will be considered as failure.
8 secondary outcomes
Disease free survival
Time frame: From randomization to any of the following events: local, regional, or distant recurrence or death from any cause, up to 3 years after treatment.
Overall survival (OS)
Time frame: From randomization to the date of death from any cause, up to 3 years after treatment.
Isolated Contralateral Neck Failure (iCNF)
Time frame: From randomization to the date of iCNF, up to 3 years after treatment.
Local-regional failure (LRF)
Time frame: From randomization to the date of any local or regional failure, up to 3 years after treatment.
Distant metastases (DM)
Time frame: From randomization until clear evidence of distant metastasis, up to 3 years after treatment.
Incidence and Severity of Treatment-Related Adverse Events
Time frame: Throughout study completion, up to 3 years after treatment.
Incidence and Severity of Treatment-Related Adverse Events reported by patients (using items of PRO-CTCAE)
Time frame: Throughout study completion, up to 2 years after treatment.
Gastrostomy tube usage
Time frame: Throughout study completion, up to 3 years after treatment.
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 21 Jul 2026.
- 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.
Sébastien THUREAU, MD study chair
Centre Henri Becquerel
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphatic mapping with SPECT-CT, Bilateral neck radiotherapy and Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy in people with Oropharyngeal Squamous Cell Carcinoma and Oropharyngeal Cancers, run by UNICANCER at 12 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 20 inclusion and 15 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: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
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?
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?
Two-years Disease Free Survival (DFS) rate (time frame: At 2 years after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2026.