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NCT Number: NCT06687200

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Leon Berard, Lyon, France

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About this study

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 depends on the quality of patient repositioning, ensured through positioning imaging, immobilization devices, and skin markers. Image-Guided Radiotherapy (IGRT) involves using imaging systems to verify the correct positioning of the patient, TVs, and OARs. IGRT has shown substantial benefits in enhancing treatment precision and reducing side effects. Translational adjustments can be applied before treatment, but, except for TomoTherapy®, which can correct roll, other rotations (pitch and yaw) require a 6D robotic table, a technology that is not widely available and limited to 3°.

The immobilization systems available and used in RT departments vary widely, classified into customizable and non-customizable systems. Two publications have shown that using a customizable immobilization system does not improve bone repositioning in these patients. Two teams have compared non-customizable immobilizations consisting of a knee support alone or combined with a foot support. The team of Cartal et al. (2015) found no significant difference in translations. However, using a knee support alone significantly reduced rotations over 3°. Laaksomaa et al. found no difference in performance between the two setups.

A pilot study in our department with 32 patients and nearly 700 images revealed an RX rotation greater than 3° in 19% of the images on average, ranging from 0% to 75% of the positioning images affected by an RX rotation over 3°. These patients were positioned supine with a knee support according to Cartal et al. Data, with a headrest or arm support added if lomboaortic irradiation was needed. Accessories were indexed, and their positions marked during the planning CT for reproducibility across sessions, with skin markers as additional setup aids.

Physical therapists recommend a maneuver called the "glute bridge," where patients bend their legs and lift their pelvis three times before straightening their legs without voluntary movement. For the study, the legs will rest on a reproducibly positioned knee support. This maneuver ensures a neutral pelvic position for each patient, relieving contractures in the lumbopelvic region. The "neutral zone" or "balance point theory," as defined by physiology and biomechanics, describes a state that relieves contractures in the lumbopelvic region and ensures balanced baseline tension across muscle groups. The pelvis lift creates co-contraction of the hamstrings, quadriceps, abdominals, and lumbar spinal muscles, promoting this balance.

In this randomized study, we propose evaluating the benefit of a neutral pelvic positioning setup achieved by the patient, in addition to immobilization devices and skin markers, on the quality of bone repositioning.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Setup with neutral pelvic positioning technique

Other

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

Other

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

Primary outcomes

  1. 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.

    Time frame: At to 3 months

Secondary outcomes

  1. The median, mean, and standard deviation of rotations (RX, RY, and RZ) obtained from the positioning imaging;

    Time frame: At to 3 months

  2. The median, mean, and standard deviation of translations (TX, TY, and TZ) obtained from the positioning imaging

    Time frame: At to 3 months

  3. The calculation of the dose delivered to nodal CTVs and organs at risk, recalculated by simulating the actual rotations observed during treatment

    Time frame: At to 24 months

  4. Gastrointestinal, urinary, and hematological toxicities graded according to NCI-CTCAE v5

    Time frame: Up to 24 months

  5. Systematic error estimation calculated using the Van Herk et al. formula

    Time frame: At to 24 months

  6. Random error estimation calculated using the Van Herk et al. formula

    Time frame: At to 24 months

  7. Estimation of nodal CTV-PTV margins calculated using the Van Herk et al. formula

    Time frame: At to 24 months

  8. 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 image

    Time frame: At to 3 months

    For irradiations including lombo-aortic nodal areas only

  9. 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 tuberosities

    Time frame: At to 24 months

    For irradiations including lombo-aortic nodal areas only

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra BOUCAUD

CONTACT

[email protected]

0478782828

Anne-Agathe SERRE

CONTACT

[email protected]

0478782828

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

Evaluation of the Interest of a "Neutral Pelvic Positioning" on the Quality of Bone Repositioning in Patients Receiving Pelvic Radiotherapy

Acronym: Pelvtilt-RT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 13, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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