RadiotherapyPelvtilt-RTNCT06687200
Assessing the Ompact of Neutral Pelvic Positioning on Bone Repositioning Quality in Pelvic Radiotherapy Patients
A study testing Setup with neutral pelvic positioning technique and Standard setup in people with Radiotherapy and Repositonning Pelvic, run by Centre Leon Berard at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiotherapy, Repositonning Pelvic, Neutral Pelvic Positioning
- What is being tested?
- Setup with neutral pelvic positioning technique and Standard setup
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesFrance
- Study dates
- 15 Nov 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Centre Leon Berard
Lyon, 69373
Alexandra BOUCAUD, 04 78 78 28 48, alexandra.boucaud@lyon.unicancer.fr
Anne-Agathe SERRE, 04 78 78 26 48, anne-agathe.serre@lyon.unicancer.fr
Institut de Cancérologie de Lorraine
Nancy, 30519
Fabienne BONNICHON, 03 83 59 84 27, f.polet@nancy.unicancer.fr
Fabienne BONNICHON
Centre Eugène Marquis
Rennes, 35042
Coralie GEFFROY, 02 99 25 31 39, c.hulot@rennes.unicancer.fr
Julie LESEUR, 02 99 25 30 57, j.leseur@rennes.unicancer.fr
Institut de Cancérologie de l'Ouest - Saint-Herblain
Saint-Herblain, 44805
Augustin MERVOYER, 02 40 67 99 00, augustin.mervoyer@ico.unicancer.fr
Augustin MERVOYER
About this study
Official title: Evaluation of the Interest of a "Neutral Pelvic Positioning" on the Quality of Bone Repositioning in Patients Receiving Pelvic Radiotherapy
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.
Read the 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 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.
- Being tested
- Setup with neutral pelvic positioning technique, Standard setup
- Keywords
- Neutral pelvic positioning, Radiotherapy, Image-Guided Radiotherapy, Glutes bridge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Setup with neutral pelvic positioning techniqueOther
Setup with neutral pelvic positioning technique (from dosimetry onward and at each session) and daily IGRT (CBCT or MVCT Mega Voltage Computed Tomography)
Standard setupOther
Standard setup (from dosimetry onward and at each session) and daily IGRT (CBCT or MVCT)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Standard setup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At to 3 months
Secondary outcomes (9)
The median, mean, and standard deviation of rotations (RX, RY, and RZ) obtained from the positioning imaging;
Measured: At to 3 months
The median, mean, and standard deviation of translations (TX, TY, and TZ) obtained from the positioning imaging
Measured: 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
Measured: At to 24 months
Gastrointestinal, urinary, and hematological toxicities graded according to NCI-CTCAE v5
Measured: Up to 24 months
Systematic error estimation calculated using the Van Herk et al. formula
Measured: At to 24 months
Random error estimation calculated using the Van Herk et al. formula
Measured: At to 24 months
Estimation of nodal CTV-PTV margins calculated using the Van Herk et al. formula
Measured: At 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 image
For irradiations including lombo-aortic nodal areas only
Measured: At to 3 months
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
For irradiations including lombo-aortic nodal areas only
Measured: At to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start15 Nov 2024 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687200
- Sponsor's protocol ID
- Pelvtilt-RT ET23-309
- Acronym
- Pelvtilt-RT
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Interest of a "Neutral Pelvic Positioning" on the Quality of Bone Repositioning in Patients Receiving Pelvic Radiotherapy
- ClinicalTrials.gov ID
- NCT06687200
- Acronym / sponsor ID
- Pelvtilt-RT / Pelvtilt-RT ET23-309
- Keywords
- Neutral pelvic positioning, Radiotherapy, Image-Guided Radiotherapy, Glutes bridge
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: Setup with neutral pelvic positioning technique | Experimental | Other: Setup with neutral pelvic positioning techniqueSetup with neutral pelvic positioning technique (from dosimetry onward and at each session) and daily IGRT (CBCT or MVCT Mega Voltage Computed Tomography). |
| Control Arm: Standard setup | Active comparator | Other: Standard setupStandard setup (from dosimetry onward and at each session) and daily IGRT (CBCT or MVCT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Setup with neutral pelvic positioning techniqueSetup with neutral pelvic positioning technique (from dosimetry onward and at each session) and daily IGRT (CBCT or MVCT Mega Voltage Computed Tomography) | Other | Experimental Arm: Setup with neutral pelvic positioning technique |
| Standard setupStandard setup (from dosimetry onward and at each session) and daily IGRT (CBCT or MVCT) | Other | Control Arm: Standard setup |
Primary outcome
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
9 secondary outcomes
The median, mean, and standard deviation of rotations (RX, RY, and RZ) obtained from the positioning imaging;
Time frame: At to 3 months
The median, mean, and standard deviation of translations (TX, TY, and TZ) obtained from the positioning imaging
Time frame: 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
Time frame: At to 24 months
Gastrointestinal, urinary, and hematological toxicities graded according to NCI-CTCAE v5
Time frame: Up to 24 months
Systematic error estimation calculated using the Van Herk et al. formula
Time frame: At to 24 months
Random error estimation calculated using the Van Herk et al. formula
Time frame: At to 24 months
Estimation of nodal CTV-PTV margins calculated using the Van Herk et al. formula
Time frame: At 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 image
Time frame: At to 3 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Setup with neutral pelvic positioning technique and Standard setup in people with Radiotherapy and Repositonning Pelvic, run by Centre Leon Berard at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra BOUCAUD (0478782828, alexandra.boucaud@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.