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Starting soon Not applicable

Assessing the Ompact of Neutral Pelvic Positioning on Bone Repositioning Quality in Pelvic Radiotherapy Patients

NCT06687200 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-11-15
Last updated
2024-11-13

Condition(s) studied

RadiotherapyRepositonning PelvicNeutral Pelvic Positioning

Investigational drug(s) / intervention(s)

Setup with neutral pelvic positioning techniqueStandard setup

Setup with neutral pelvic positioning technique: Setup with neutral pelvic positioning technique (from dosimetry onward and at each session) and daily IGRT (CBCT or MVCT Mega Voltage Computed Tomography)

Standard setup: Standard setup (from dosimetry onward and at each session) and daily IGRT (CBCT or MVCT)

Study summary

This study explores whether achieving a neutral pelvic position improves bone repositioning quality for patients undergoing pelvic radiotherapy. While Intensity-Modulated Radiotherapy (IMRT) and Image-Guided Radiotherapy (IGRT) have enhanced target volume precision and reduced side effects, effective patient positioning remains crucial. However, rotational adjustments are limited without a specialized robotic table. Current immobilization devices, customizable or not, show limited impact on positioning accuracy, with mixed results on the use of knee and foot supports. A pilot study identified significant rotational variation, and to address this, a "glute bridge" maneuver is proposed to ensure a neutral pelvic position. This randomized study will evaluate the impact of this maneuver on positioning quality when combined with immobilization and skin markers.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: I1. Female, aged ≥ 18 years; I2. Patient scheduled for intensity-modulated radiotherapy for pelvic cancer, with an irradiation field extending at least up to L5-S1 on an accelerator equipped with a 3D imaging system (CBCT or MVCT) with automatic registration; I3. Patient affiliated with a social security scheme or equivalent; I4. Dated and signed informed consent. Exclusion Criteria: E1. Patient unable or unwilling to lift the pelvis; E2. Patient with anal or vulvar carcinoma; E3. Patient with unstable spondylolisthesis; E4. Patient with an unhealed lumbar or pelvic fracture; E5. Patient with a recent muscle injury in the relevant muscle groups; E6. Patient with an ECOG performance status ≥ 2; E7. Pregnant or breastfeeding patient.

Primary outcome measure(s)

  • The rate of images with RX > 3° will be calculated for each patient as the number of sessions with a repositioning image where RX is > 3°, relative to the total number of sessions performed. — At to 3 months

Trial sites (4)

FacilityCityRegionStatus
Centre Leon Berard Lyon France
Institut de Cancérologie de Lorraine Nancy France
Centre Eugène Marquis Rennes France
Institut de Cancérologie de l'Ouest - Saint-Herblain Saint-Herblain France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06687200 on ClinicalTrials.gov ↗ ← All trials in France