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

Not Applicable
Not yet recruiting
Conditions
Registration Number
NCT06687200
Lead Sponsor
Centre Leon Berard
Brief 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 a...

Detailed Description

Radiotherapy (RT) is an integral part of curative treatment for pelvic cancers. Intensity-Modulated Radiotherapy (IMRT) has demonstrated benefits in target volume (TV) coverage and sparing healthy tissues. IMRT achieves a highly conformal dose distribution, with steep dose gradients between the TVs and Organs at Risk (OARs). However, its effectiveness depend...

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
200
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.

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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.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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
Secondary Outcome Measures
NameTimeMethod
The median, mean, and standard deviation of rotations (RX, RY, and RZ) obtained from the positioning imaging;At to 3 months
The median, mean, and standard deviation of translations (TX, TY, and TZ) obtained from the positioning imagingAt to 3 months
The calculation of the dose delivered to nodal CTVs and organs at risk, recalculated by simulating the actual rotations observed during treatmentAt to 24 months
Gastrointestinal, urinary, and hematological toxicities graded according to NCI-CTCAE v5Up to 24 months
Systematic error estimation calculated using the Van Herk et al. formulaAt to 24 months
Random error estimation calculated using the Van Herk et al. formulaAt to 24 months
Estimation of nodal CTV-PTV margins calculated using the Van Herk et al. formulaAt to 24 months
Evaluation of repositioning error in relation to L4, without applying rotations, will be obtained using the mean and standard deviation of measurements between the anterosuperior part of the L4 vertebral body on the reference image and on the daily imageAt to 3 months

For irradiations including lombo-aortic nodal areas only

Evaluation of the RX rotation discrepancy observed after registering the daily image to the reference image, comparing two regions of interest: one defined by L1-L5 and the other defined from the iliac crests to the ischial tuberositiesAt to 24 months

For irradiations including lombo-aortic nodal areas only

Trial Locations

Locations (4)

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

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