SPECT-CT Guided ELEctive Contralateral Neck Treatment in Lateralized Oropharyngeal Cancer

NCT07241273 | Not Yet Recruiting DMC

• 2 other identifiers: UC-RAD-25062025-A00913-46
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 12

Brief 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. 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.

Conditions

Oropharyngeal Cancers; Oropharyngeal Carcinoma; Head and Neck; Head and Neck Cancer; Head and Neck Cancers; Oropharyngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  At 2 years after treatment

Secondary Outcomes (8)

• Disease free survival

  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)

  From randomization to the date of death from any cause, up to 3 years after treatment.

• Isolated Contralateral Neck Failure (iCNF)

  From randomization to the date of iCNF, up to 3 years after treatment.

• Local-regional failure (LRF)

  From randomization to the date of any local or regional failure, up to 3 years after treatment.

• Distant metastases (DM)

  From randomization until clear evidence of distant metastasis, up to 3 years after treatment.

Study Arms (2)

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

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

Radiation: Bilateral neck radiotherapy

Interventions

Lymphatic mapping with SPECT-CT OTHER

Lymphatic mapping with SPECT-CT

Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy

Bilateral neck radiotherapy RADIATION

Patients will receive definitive radiotherapy to the primary tumour and bilateral neck nodes.

Bilateral neck radiotherapy

Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy RADIATION

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.

Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• UNICANCER: lead
• National Cancer Institute, France: collaborator

Study Sites (12)

CHU Brest

Brest, France

Location

Centre François Baclesse

Caen, France

Location

CHU Caen

Caen, France

Location

Centre Georges François Leclerc

Dijon, France

Location

Centre de Radiothérapie Guillaume Le Conquérant

Le Havre, France

Location

Centre Oscar Lambret

Lille, France

Location

Institut Régional du Cancer de Montpellier

Montpellier, France

Location

Hôpital Tenon

Paris, France

Location

Centre Henri Becquerel

Rouen, France

Location

Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

Strasbourg, France

Location

Institut de Cancérologie Strasbourg Europe

Strasbourg, France

Location

CHRU Tours - Hôpital Bretonneau

Tours, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Oropharyngeal Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Sébastien THUREAU, MD

  Centre Henri Becquerel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 21, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2031
• Last Updated: March 24, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)