Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain (Celiac SRS)

29 juillet 2026 mis à jour par: University Health Network, Toronto

A Prospective Pilot Clinical Trial of Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain

This is a prospective, single-arm, pilot feasibility clinical trial designed to evaluate the feasibility and safety of a simulation-free adaptive radiotherapy workflow to enable single-session celiac plexus SBRT planning and delivery. In this trial, the treatment itself is non-investigational (standard-of-care celiac plexus SBRT) but the treatment workflow (simulation-free, using adaptive radiotherapy to compress treatment planning and delivery into a single session) is novel. Investigators hypothesize the successful completion of the simulation-free ART workflow through treatment delivery in the first on-table treatment attempt for at least 80% of patients.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

A standard treatment for pain caused by cancer affecting the celiac plexus (a group of nerves in the upper abdomen behind the stomach and pancreas) is a type of radiation therapy called stereotactic body radiotherapy (SBRT). In the usual process for this type of radiation treatment, the patient would first have a special radiation planning scan called a computer tomography simulation (CTsim) to create a personalized treatment plan. The planning process usually takes 5 to 10 days, which means treatment may begin up to 2 weeks after the initial CTsim scan. Recent technology has allowed for treatment to be planned without a separate CTsim scan, called a CTsim-free workflow. In this study, investigators will use pre-existing scans (such as diagnostic imaging) to create the patient's treatment plan. On the day of treatment, the care team will use a technique called Adaptive Radiotherapy (ART) to adjust the plan based on the patient body's position and anatomy that day, allowing planning and treatment to happen in a single visit.

Type d'étude

Interventionnel

Inscription (Estimé)

5

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recrutement
        • Princess Margaret Cancer Centre
        • Chercheur principal:
          • Michael Yan

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:

  • Subjects must have histologically or cytologically confirmed cancer that is metastatic or unresectable, and considered appropriate per the treating physician to receive celiac plexus SBRT.
  • Age >18 years. Because no data are currently available on the use of celiac axis SBRT in subjects ≤18 years of age, children are excluded from this study.
  • Performance status: ECOG Performance status ≤ 3
  • Severe retroperitoneal pain syndrome (radiates from the lower back to the upper abdomen, belt- like distribution), intensity of at least 5 on 11-point Brief Pain Inventory (BPI, average pain) scale.
  • Subjects must have anatomical involvement of the celiac plexus on the diagnostic CT, PET/CT, or MRI. This includes: Any pancreatic cancer, any other cancer that on imaging demonstrates either gross involvement of the celiac blood vessels or celiac plexus on imaging OR haziness around the celiac blood vessels that typically implies tumor engulfment.
  • Prior chemotherapy or biological treatment is allowed, but any active oncological treatment should be stopped at least 1 week prior to radiation therapy and renewed at least 1 week following radiation therapy.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.
  • Subjects must have a diagnostic CT of the abdomen and pelvis, with or without contrast, acquired < 28 days prior to the study consent.

Exclusion Criteria:

  • In ability to tolerate lying supine and still for at least 45 minutes.
  • Performance status: ECOG Performance status of 4.
  • Previous radiotherapy to the upper abdomen overlapping with the projected site of treatment.
  • Pregnant or breastfeeding women are excluded from this study.
  • Subjects with conditions associated with increased risk of side effects from radiation such as inflammatory bowel disease and scleroderma.
  • Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol principal investigator, documentation of this exception is sufficient in lieu of a pregnancy test.

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: Sim-free ART workflow
Autre: Treatment plan
Simulation-free radiation treatment planning, in which pre-existing diagnostic images are used to generate a radiation treatment pre-plan (as opposed to acquiring planning-specific image sets). This will be paired with the use of online adaptive radiotherapy (ART) to refine the pre-plan to create a final plan that matches the on-table internal target and gastrointestinal anatomy observed with on-board imaging on the day of treatment. This enables single-session celiac plexus SBRT planning and delivery.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Successful treatment plan workflow of 80% of patients
Délai: 1 year

The feasibility and safety of the simulation-free adaptive radiotherapy workflow for celiac plexus SBRT for clinical use. Feasibility defined as the successful completion of the simulation-free ART workflow through treatment delivery in the first on-table treatment attempt for at least 80% of patients.

All of the following criteria must be met to be deemed feasible:

  • Meets all priority 1 OAR constraints
  • Meets a PTV_Opt_2500 and PTV_Opt_2000 priority 2 constraints
  • Patient specific QA pass as per institutional standards
  • Patient able to tolerate treatment position for CBCT and entirety of treatment process. If a break is required and the patient is repositioned, the ART process must repeat from CBCT acquisition
  • Complete delivery of all planned monitor units
1 year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Component time
Délai: 1 year
Average time required for each component of the simulation-free ART workflow, including but not limited to plan generation using diagnostic imaging, pre-treatment activities (e.g., on-table patient setup/imaging, dose prediction, segmentation of daily contours, plan optimization and evaluation), and treatment delivery.
1 year
Dosimetric comparison of radiation plans
Délai: 1 year
Dosimetric comparison of radiation plans created on traditional offline CBCT images with those created using the simulation-free ART workflow (i.e., comparison of target coverage, sparing of organs-at-risk).
1 year
Frequency of online re-adaptation
Délai: 1 Year
Frequency of online re-adaptation within the sim-free workflow. Readaptation defined as the need to regenerate a treatment plan after an initial plan had been generated that does not satisfy treatment parameters.
1 Year
Patient satisfaction
Délai: 1 year
Overall patient satisfaction with celiac plexus SBRT using a simulation-free, adaptive radiotherapy workflow. This will be assessed using the Radiotherapy Experience Questionnaire (RTEQ) which is a validated RT experience questionnaire that reports patient experiences with the overall treatment process by answering statements on a scale of strongly agree to strongly disagree. Given that this is a novel workflow/process, the results of the questionnaire will shed light on their overall experience.
1 year
TCAE Grade 3+ Toxicity
Délai: 6 weeks
Any CTCAE Grade 3+ Toxicity at 6 weeks related to the SBRT treatment.
6 weeks
Cost of workflow
Délai: 1 year
The overall cost of simulation free workflow compared to select retrospective cases treated on conventional workflow. Timepoints include simulation, planning, treatment, and follow up. Components include planning, therapist, clinician.
1 year
Mean difference between diagnostic and ETHOS plans (COM)
Délai: 1 year
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk. These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel. Rigid registration to spinal column as baseline (or aorta). Metrics will include center of mass (COM).
1 year
Mean difference between diagnostic and ETHOS plans (DTA)
Délai: 1 year
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk. These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel. Rigid registration to spinal column as baseline (or aorta). Metrics will include distance to agreement (DTA).
1 year
Mean difference between diagnostic and ETHOS plans (ASSD)
Délai: 1 year
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk. These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel. Rigid registration to spinal column as baseline (or aorta). Metrics will include average symmetric surface distance (ASSD).
1 year
Mean difference between diagnostic and ETHOS plans (DSC)
Délai: 1 Year
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk. These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel. Rigid registration to spinal column as baseline (or aorta). Metrics will include dice for volume overlap (DSC).
1 Year
Mean difference between diagnostic and ETHOS plans (DVF)
Délai: 1 Year
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk. These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel. Rigid registration to spinal column as baseline (or aorta). Metrics will include deformation vector field (DVF).
1 Year
Change in the Brief Pain Inventory pain scale
Délai: 6 Weeks
Change in Brief Pain Inventory pain scale, where on a scale 0 is "No Pain" and 10 is "Pain as bad as you can imagine", recorded in the pain diary at baseline/screening, day of SBRT prior to treatment, and 6 weeks after sim-free celiac plexus SBRT.
6 Weeks
Change in Amount of Pain Medication
Délai: 6 weeks
Change in the amount of pain medications (Morphine equivalents) recorded in the pain diary at baseline/screening, day of SBRT prior to treatment, and 6 weeks after sim-free celiac plexus SBRT. Patients will record number of medication units taken (unit of medication is a tablet or capsule, a millilitre (mL) of liquid, a suppository, or a patch).
6 weeks

Collaborateurs et enquêteurs

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

Parrainer

University Health Network, Toronto

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 (Réel)

4 juin 2026

Achèvement primaire (Estimé)

1 juin 2027

Achèvement de l'étude (Estimé)

1 juin 2027

Dates d'inscription aux études

Première soumission

26 mai 2026

Première soumission répondant aux critères de contrôle qualité

3 juin 2026

Première publication (Réel)

9 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 25-5377

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

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 .

S'abonner