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

NCT06687200 | Not Yet Recruiting DMC

• 1 other identifier: Pelvtilt-RT ET23-309
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Radiotherapy; Repositonning Pelvic; Neutral Pelvic Positioning

Keywords

Neutral pelvic positioning; Radiotherapy; Image-Guided Radiotherapy; Glutes bridge

Outcome Measures

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.

  At to 3 months

Secondary Outcomes (9)

• 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 imaging

  At to 3 months

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

  At to 24 months

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

  Up to 24 months

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

  At to 24 months

Study Arms (2)

Experimental Arm: Setup with neutral pelvic positioning technique

EXPERIMENTAL

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

Other: Setup with neutral pelvic positioning technique

Control Arm: Standard setup

ACTIVE COMPARATOR

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

Other: Standard setup

Interventions

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)

Experimental Arm: Setup with neutral pelvic positioning technique

Standard setup OTHER

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

Control Arm: Standard setup

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (4)

Centre Leon Berard

Lyon, 69373, France

Location

Institut de Cancérologie de Lorraine

Nancy, 30519, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Institut de Cancérologie de l'Ouest - Saint-Herblain

Saint-Herblain, 44805, France

Location

Central Study Contacts

Alexandra BOUCAUD

CONTACT

0478782828; alexandra.boucaud@lyon.unicancer.fr

Anne-Agathe SERRE

CONTACT

0478782828; anne-agathe.serre@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 13, 2024

Record last verified: 2024-11

Locations

FR (4)