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STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection

27 mai 2026 mis à jour par: Jonsson Comprehensive Cancer Center

STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection for the Treatment of Sporadic Medullary Thyroid Cancer, STAGE-MTC Trial

This clinical trial studies how well thyroid lobectomy with ipsilateral central neck dissection works to treat medullary thyroid cancer (MTC) in patients without a germline RET mutation (sporadic). Currently, sporadic and germline RET (rearranged during transfection) mutation positive MTCs that are limited to the thyroid are managed in the same way, complete surgical removal of the entire thyroid gland (total thyroidectomy) with surgical removal of lymph nodes and other tissues on both sides of the neck (bilateral central neck dissection). Total thyroidectomy and bilateral central neck dissection carry a high risk of complications, and total thyroidectomy requires patients to take lifelong thyroid hormone replacement therapy, which can impact quality of life. Research has shown that patients with sporadic MTC do not have a high risk of developing MTC in the remaining normal thyroid tissue and that they may be able to be managed differently than patients with germline RET mutations. Thyroid lobectomy with ipsilateral central neck dissection is a surgical procedure which removes only the lobe of the thyroid gland that is affected by cancer as well as the lymph nodes and other tissues from the affected side of the neck. Thyroid lobectomy with ipsilateral central neck dissection may be a safer, more tolerable, and/or more effective way to treat sporadic MTC.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

PRIMARY OBJECTIVE:

I. To determine the number of patients that have no biochemical evidence of persistent medullary thyroid cancer following thyroid lobectomy and ipsilateral prophylactic central neck dissection alone versus number of patients with biochemical evidence of persistent MTC that requires completion thyroidectomy.

SECONDARY OBJECTIVES:

I. Determine the short-term oncologic treatment outcomes of a novel staged approach to sporadic medullary thyroid cancer, defined by response to therapy category (excellent, biochemical incomplete, structural incomplete).

II. Determine the prevalence of undetected foci of medullary thyroid cancer in contralateral thyroid lobe and contralateral lymph nodes.

OUTLINE:

Patients undergo thyroid lobectomy with unilateral central neck dissection on study. Patients then undergo blood sample collection for calcitonin and carcinoembryonic antigen (CEA) monitoring with neck ultrasound and/or gallium-68 (Ga-68) or fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/computed tomography (CT) at 3 and 6 month follow-ups. Patients with no biochemical or imaging evidence of persistent disease undergo routine cancer surveillance. Patients with either of the following: 1) Elevated or rising calcitonin and/or CEA plus imaging suggestive of residual disease in the contralateral thyroid lobe or contralateral cervical lymph nodes, or 2) Elevated or rising calcitonin and/or CEA with negative imaging for an alternate source, consistent with biochemical evidence of residual disease in the remaining thyroid lobe, may undergo completion thyroidectomy and/or contralateral neck dissection during follow up. Patients also undergo additional blood sample collection, neck ultrasound, and/or Ga-68 or FDG PET/CT throughout the study.

After completion of study intervention, patients are followed up at day 14 and months 3, 6, 12, 18, and 24.

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • California
      • Los Angeles, California, États-Unis, 90095
        • UCLA / Jonsson Comprehensive Cancer Center
        • Chercheur principal:
          • James Wu, MD
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Male or female ≥ 18 years of age at time of diagnosis

  • Documentation of a medullary thyroid cancer diagnosis as evidenced by:

    • Thyroid fine needle aspiration biopsy with cytologist consistent with medullary thyroid cancer
    • Indeterminate cytology from thyroid fine needle aspiration with elevated serum calcitonin OR thyroid molecular testing consistent with medullary thyroid cancer
  • Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study
  • Appropriate candidate for thyroid lobectomy and/or total thyroidectomy

Exclusion Criteria:

  • Indication for total thyroidectomy unrelated to medullary thyroid cancer:

    • Graves' disease
    • Symptomatic multinodular goiter
    • Contralateral symptomatic benign nodules

  • Ultrasound findings consistent with:

    • Cervical lymphadenopathy involving lateral neck or contralateral central neck

    • Suspicious thyroid nodules > 1 cm that are Thyroid Imaging Reporting and Data Systems 2 (TIRADS2) or higher without fine needle aspiration (FNA)

      • Pure cystic and spongiform nodules do not require FNA
      • Patients with nodules that meet criteria above can elect to undergo FNA, and may enroll in study if benign cytology is noted
  • Identification of germline RET mutation on preoperative genetic testing

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Treatment (thyroid lobectomy, unilateral neck dissection)
Patients undergo thyroid lobectomy with unilateral central neck dissection on study. Patients then undergo blood sample collection for calcitonin and CEA monitoring with neck ultrasound and/or Ga-68 or FDG PET/CT at 3 and 6 month follow-ups. Patients with no biochemical or imaging evidence of persistent disease undergo routine cancer surveillance. Patients with either of the following: 1) Elevated or rising calcitonin and/or CEA plus imaging suggestive of residual disease in the contralateral thyroid lobe or contralateral cervical lymph nodes, or 2) Elevated or rising calcitonin and/or CEA with negative imaging for an alternate source, consistent with biochemical evidence of residual disease in the remaining thyroid lobe, may undergo completion thyroidectomy and/or contralateral neck dissection during follow up. Patients also undergo additional blood sample collection, neck ultrasound, and/or Ga-68 or FDG PET/CT throughout the study.
Procédure: Collecte d'échantillons biologiques
Subir une collecte d'échantillons de sang
Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Procédure: Imagerie échographique
Passer une échographie du cou
Autres noms:
  • Ultrason
  • Imagerie ultrasonore bidimensionnelle en niveaux de gris
  • Imagerie échographique bidimensionnelle
  • 2D-US
  • Échographie
  • Ultrason, Médical
  • NOUS
Procédure: FDG-Positron Emission Tomography and Computed Tomography Scan
Undergo FDG PET/CT
Autres noms:
  • FDG TEP/TDM
Procédure: Ga-68 PET/CT Scan
Undergo Ga-68 PET/CT
Autres noms:
  • Gallium-68 PET/CT Scan
  • Gallium-68 Positron Emission Tomography and Computed Tomography Scan
Procédure: Neck Dissection
Undergo unilateral central neck dissection
Procédure: Neck Dissection
Undergo contralateral neck dissection
Comportemental: Surveillance
Undergo routine cancer surveillance
Autres noms:
  • Épidémiologie / Surveillance
Procédure: Thyroid Lobectomy
Undergo thyroid lobectomy
Autres noms:
  • Lobectomy of Thyroid Gland
  • Unilateral Thyroid Lobectomy
Procédure: Thyroidectomy
Undergo completion thyroidectomy

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of patients who achieve biochemical remission
Délai: Up to 3 months
Will calculate the proportion of patients who achieve biochemical remission at 3 months (normal calcitonin and carcinoembryonic antigen [CEA]). Exact 95% confidence intervals will be provided. Exploratory subgroup analyses (e.g., stratified by baseline calcitonin level, tumor size, or nodal status) may be conducted to generate hypotheses but will not be powered for formal inference.
Up to 3 months
Proportion of patients requiring completion thyroidectomy
Délai: Up to 12 months
Completion thyroidectomy will be indicated in the setting of: Elevated or rising calcitonin and/or CEA plus imaging (neck ultrasound or positron emission tomography [PET]/computed tomography [CT]) suggestive of residual disease in the contralateral thyroid lobe or contralateral cervical lymph nodes; or elevated or rising calcitonin and/or CEA with negative neck ultrasound and PET/CT for an alternate source, consistent with biochemical evidence of residual disease in the remaining thyroid lobe. Exact 95% confidence intervals will be provided. Exploratory subgroup analyses (e.g., stratified by baseline calcitonin level, tumor size, or nodal status) may be conducted to generate hypotheses but will not be powered for formal inference.
Up to 12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Short-term oncologic outcomes
Délai: At 12 months
Short-term oncologic outcomes will be categorized according to the American Thyroid Association ATA) "response to therapy" framework, adapted for medullary thyroid carcinoma. Categories will include: Excellent response: Normal calcitonin and CEA with no structural evidence of disease on imaging; Biochemical incomplete response: Abnormal calcitonin and/or CEA without structural evidence of disease; Structural incomplete response: Evidence of structural disease on imaging, regardless of biochemical status. Will be summarized descriptively. Exact 95% confidence intervals will be reported. Comparisons to baseline disease features (e.g., initial calcitonin levels, tumor size, lymph node involvement) may be explored but will be considered hypothesis-generating only.
At 12 months
Prevalence of occult contralateral disease
Délai: Perioperative/Periprocedural
Among patients who undergo completion thyroidectomy and/or contralateral neck dissection, will assess the prevalence of previously undetected foci of medullary thyroid cancer in the contralateral thyroid lobe and contralateral cervical lymph nodes. Pathologic findings will be reported as proportions with corresponding exact 95% confidence intervals.
Perioperative/Periprocedural

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Jonsson Comprehensive Cancer Center

Collaborateurs

Eli Lilly and Company

Les enquêteurs

  • Chercheur principal: James Wu, MD, UCLA / Jonsson Comprehensive Cancer Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

2 septembre 2026

Achèvement primaire (Estimé)

2 septembre 2031

Achèvement de l'étude (Estimé)

21 avril 2032

Dates d'inscription aux études

Première soumission

18 mai 2026

Première soumission répondant aux critères de contrôle qualité

27 mai 2026

Première publication (Réel)

28 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 25-0553
  • NCI-2026-03211 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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