Radiotherapy of multiple extracranial metastases simultaneously according to a common radiation plan vs sequentially according to a radiation plan per metastasis

Switzerland (ICTRP)

ICTRP Studien-ID
NCT06230666 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
SINGLE-ISOCENTER SBRT VS MULTIPLE-ISOCENTER SBRT FOR MULTIPLE EXTRACRANIAL METASTASES: a randomized controlled non-inferiority clinical trial (BASEC)

Wissenschaftlicher Titel
Single-isocenter SBRT vs. Multiple-isocenter SBRT for Multiple Extracranial Metastases: a Randomized Controlled Non-inferiority Clinical Trial (ICTRP)

Öffentlicher Titel
Single-isocenter SBRT vs. Multiple-isocenter SBRT for Multiple Extracranial Metastases (ICTRP)

Untersuchte Krankheit(en)

Metastatic Cancer

(ICTRP)

Untersuchte Intervention

Radiation: SBRT

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Studientyp
Interventional (ICTRP)

Studiendesign

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

(ICTRP)

Ein-/Ausschlusskriterien

Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

• Written informed consent according to Swiss law and ICH/GCP regulations signed and dated by the participant and the investigator before any trial specific procedures (Informed Consent Form);
• Distant extracranial metastases (lung, mediastinal/cervical lymph node, liver, bone including spinal/paraspinal and abdominal/pelvic) from histologically confirmed cancer;
• Distant metastases confirmed by imaging:
• CT is required in all cases;
• MRI is required for spinal and recommended for liver metastases;
• PET/CT is recommended for tumors showing high uptake of 18F-FDG, 11Ccholine, 68Ga- or 18F-PSMA;
• At least 2 distant metastases that are amendable to treat with a single isocenter approach according to the judgment of the treating clinician;
• Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures.

Exclusion Criteria:

• Prior radiotherapy for distant metastases if overlapping previous and current treatment plans leads to excessive dose to OARs;
• Distant metastases with extension into the gastrointestinal tract, skin;
• Large inter-lesion distance and location of distant metastases in different organs with different motion patterns;
• Women who are pregnant or breast feeding;
• Intention to become pregnant during the course of the trial;
• Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases;
• Known or suspected non-compliance, drug or alcohol abuse;
• Inability to follow the procedures of the trial, e.g. due to language problems of the participant;
• Enrolment of the investigator, his/her family members, employees and other dependent persons.

Female participants who underwent hysterectomy and/or bilateral oophorectomy or
postmenopausal for longer than 2 years are not considered as being of child bearing
potential.

(ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte

Freedom from local disease progression at the site of treated metastases

(ICTRP)

Acute adverse events (AEs);Late adverse events (AEs);Overall survival;Progression-free survival;Overall treatment time

(ICTRP)

Registrierungsdatum
nicht verfügbar

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
nicht verfügbar

Weitere Kontakte
Indira Madani, MD, PhD, indira.madani@usz.ch, +41 44 255 37 68 (ICTRP)

Sekundäre IDs
2023-01904 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06230666 (ICTRP)