Pelvis TumorsBoost_PelvisNCT03206385
IMRT Followed by CyberKnife Boost Focused on the Gross Residual Pelvic Tumor Volume
An observational study of Pelvis Tumors, run by Centre Francois Baclesse, Luxembourg at 1 site in Luxembourg.
Trial summary
The present register has been designed to confirm the hypothesis that while using high quality Intensity Modulated Radiation Techniques (IMRT) and a reduced external beam stereotactic boost component it would be possible to maintain the late severe toxicity rates under the 5 % level in situations where brachytherapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvis Tumors
- What is being tested?
- Radiation treatment and CK Boost Pelvis
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteLuxembourg
- Study dates
- 31 May 2017to 31 Dec 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with any kind of non-resected pelvic cancer for which a brachytherapy Gross Tumor Volume (GTV) boost is non indicated
Who may be able to join
- any kind of locally advanced pelvic tumor, non-operable for any reason
- signed informed consent
- concomitant chemotherapy or hormonotherapy unless gemcitabine will not be contraindicated during the treatment
Who cannot join
- possibility to easily offer the patient a brachytherapy boost
- extra pelvic tumor dissemination above the L3 vertebra
- collagenoses
- any bowel tumor when the digestive tract is not definitely and locally bypassed
- any biologic targeted therapy or anti angiogenic therapy within the 6 weeks preceding the initiation of the radiation treatment, for the first 20 patients. This point will be revisited afterwards and will conduct to an amendment in case of protocol modification
- gemcitabine chemotherapy within the 6 weeks preceding the initiation of the radiation treatment or during the treatment
- hip prostheses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensity Modulated Radiation Treatments Followed by A Stereotactic CyberKnife Boost Focused on the Gross Residual Pelvic Tumor Volume
The present register has been designed to confirm the hypothesis that while using high quality Intensity Modulated Radiation Techniques (IMRT) and a reduced external beam stereotactic boost component it would be possible to maintain the late severe toxicity rates under the 5 % level in situations where brachytherapy could not be proposed as a boost.
Read the detailed description
This register concerned patients with any kind of non-resected pelvic cancer for which a brachytherapy Gross Tumor Volume (GTV) boost is non indicated.
- Placement of fiducials First of all, fiducials will be placed near or inside the Gross Tumor Volume (GTV).
- Radiation treatment The radiation treatment will be delivered by Varian Rapid ARC accelerators. 50 Gy will be delivered in the Planning Tumor Volume (PTV) 1 and 60 Gy in the PTV 2 simultaneously in 28 fractions (5 fractions a week) in no more than 40 days. Anytime, 95% of the prescribed dose will have to cover at least 90% of the PTV 1 and PTV 2.
- CK Boost pelvis In the following 14 days after the external beam treatment, two high CyberKnife dose sessions will deliver a pelvic boost of 6.5 Gy each to the initial GTV or eventually to the residual GTV in case of too close vicinity of the organs at risk (OAR). This boost will be planned according to a recent paper, using a new CT scan and MRI scan for planimetric purposes. 95% of the prescribed dose will have to cover at least 90% of the PTV. The maximal CyberKnife tolerated doses to the OAR for a 6.5 Gy dose will be 5 Gy to 2cc of the bladder, rectum or sigmoid structures and 2.5 Gy to 5 cc of the small bowel. The protocol will not require a dose summation of the different steps of the treatment. The total duration of the whole treatment will have to be inferior to 55 days.
4 Follow-up The clinical follow up will be planed weekly during the radiation treatments, and at 2, 4 and 6 months thereafter. The patients will be then followed up every 4 months during the first 2 years and twice yearly thereafter.
A medical imaging using PET Scanner and MRI when possible will be performed at least at 6 months intervals during the first 2 years.
- Conditions
- Pelvis Tumors
- Being tested
- Radiation treatment, CK Boost Pelvis
- Medical subject headings
- Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation treatmentRadiation
50 Gy will be delivered in the PTV 1 and 60 Gy in the PTV 2 simultaneously in 28 fractions (5 fractions a week) in no more than 40 days. Anytime, 95% of the prescribed dose will have to cover at least 90% of the PTV 1 and PTV 2.
CK Boost PelvisRadiation
Two high CyberKnife dose sessions will deliver a pelvic boost of 6.5 Gy each to the initial GTV or eventually to the residual GTV in case of too close vicinity of the OAR
| Study group | Role | What they receive |
|---|---|---|
| CK Boost pelvis | Not described Receives: Radiation: Radiation treatment; Radiation: CK Boost Pelvis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe toxicity
The objective is to confirm an expected toxicity level of severe toxicity < 5%
Measured: follow up during 3 years after patient inclusion
Secondary outcomes (3)
Local clinical control rates
Ths objective is to study the local control rates defined by a study panel board including at least a radiologist specially trained to review the imaging data after high radiation doses per fraction and the coordinator of the register, using PET Scanner, MRI and clinical data
Measured: follow up during 3 years after patient inclusion
Extra pelvic dissemination rates
The objective is to study the dissemination data of the disease above the pelvis
Measured: follow up during 3 years after patient inclusion
Ability of the multi leaf collimator to better cover the PTVs and to help shortening the delivery times
Using the different Conformal Index modalities, the objective is to compare the treatment planning with or without using the multi leaf collimator
Measured: follow up during 3 years after patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start31 May 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvis TumorsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse, Luxembourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206385
- Sponsor's protocol ID
- CK Boost Pelvis
- Acronym
- Boost_Pelvis
- Status last verified
- Jun 2022
- First submitted
- 30 Jun 2017
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity Modulated Radiation Treatments Followed by A Stereotactic CyberKnife Boost Focused on the Gross Residual Pelvic Tumor Volume
- ClinicalTrials.gov ID
- NCT03206385
- Acronym / sponsor ID
- Boost_Pelvis / CK Boost Pelvis
- Conditions
- Pelvis Tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Francois Baclesse, LuxembourgUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Jul 2017 (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.
The present register has been designed to confirm the hypothesis that while using high quality Intensity Modulated Radiation Techniques (IMRT) and a reduced external beam stereotactic boost component it would be possible to maintain the late severe toxicity rates under the 5 % level in situations where brachytherapy could not be proposed as a boost.
Detailed description
This register concerned patients with any kind of non-resected pelvic cancer for which a brachytherapy Gross Tumor Volume (GTV) boost is non indicated.
- Placement of fiducials First of all, fiducials will be placed near or inside the Gross Tumor Volume (GTV).
- Radiation treatment The radiation treatment will be delivered by Varian Rapid ARC accelerators. 50 Gy will be delivered in the Planning Tumor Volume (PTV) 1 and 60 Gy in the PTV 2 simultaneously in 28 fractions (5 fractions a week) in no more than 40 days. Anytime, 95% of the prescribed dose will have to cover at least 90% of the PTV 1 and PTV 2.
- CK Boost pelvis In the following 14 days after the external beam treatment, two high CyberKnife dose sessions will deliver a pelvic boost of 6.5 Gy each to the initial GTV or eventually to the residual GTV in case of too close vicinity of the organs at risk (OAR). This boost will be planned according to a recent paper, using a new CT scan and MRI scan for planimetric purposes. 95% of the prescribed dose will have to cover at least 90% of the PTV. The maximal CyberKnife tolerated doses to the OAR for a 6.5 Gy dose will be 5 Gy to 2cc of the bladder, rectum or sigmoid structures and 2.5 Gy to 5 cc of the small bowel. The protocol will not require a dose summation of the different steps of the treatment. The total duration of the whole treatment will have to be inferior to 55 days.
4 Follow-up The clinical follow up will be planed weekly during the radiation treatments, and at 2, 4 and 6 months thereafter. The patients will be then followed up every 4 months during the first 2 years and twice yearly thereafter.
A medical imaging using PET Scanner and MRI when possible will be performed at least at 6 months intervals during the first 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CK Boost pelvis | – | Radiation: Radiation treatment, Radiation: CK Boost Pelvis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with any kind of non-resected pelvic cancer for which a brachytherapy Gross Tumor Volume (GTV) boost is non indicated
Key inclusion criteria (3 listed)
- any kind of locally advanced pelvic tumor, non-operable for any reason
- signed informed consent
- concomitant chemotherapy or hormonotherapy unless gemcitabine will not be contraindicated during the treatment
Key exclusion criteria (7 listed)
- possibility to easily offer the patient a brachytherapy boost
- extra pelvic tumor dissemination above the L3 vertebra
- collagenoses
- any bowel tumor when the digestive tract is not definitely and locally bypassed
- any biologic targeted therapy or anti angiogenic therapy within the 6 weeks preceding the initiation of the radiation treatment, for the first 20 patients. This point will be revisited afterwards and will conduct to an amendment in case of protocol modification
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 |
|---|---|---|
| Radiation treatment50 Gy will be delivered in the PTV 1 and 60 Gy in the PTV 2 simultaneously in 28 fractions (5 fractions a week) in no more than 40 days. Anytime, 95% of the prescribed dose will have to cover at least 90% of the PTV 1 and PTV 2. | Radiation | CK Boost pelvis |
| CK Boost PelvisTwo high CyberKnife dose sessions will deliver a pelvic boost of 6.5 Gy each to the initial GTV or eventually to the residual GTV in case of too close vicinity of the OAR | Radiation | CK Boost pelvis |
Primary outcome
Severe toxicity
Time frame: follow up during 3 years after patient inclusion
The objective is to confirm an expected toxicity level of severe toxicity < 5%
3 secondary outcomes
Local clinical control rates
Time frame: follow up during 3 years after patient inclusion
Extra pelvic dissemination rates
Time frame: follow up during 3 years after patient inclusion
Ability of the multi leaf collimator to better cover the PTVs and to help shortening the delivery times
Time frame: follow up during 3 years after patient inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvis Tumors, run by Centre Francois Baclesse, Luxembourg at 1 site in Luxembourg.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Luxembourg. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe toxicity (time frame: follow up during 3 years after patient inclusion). 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 22 Jun 2022.