CraniopharyngiomaPhase 2NCT02842723
Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy (Craniopharyngioma)
A Phase 2 study testing Protontherapy in people with Craniopharyngioma, run by Institut Curie at 3 sites in France.
Trial summary
Prospective, open labelled, phase II, monocenter trial to combine partial surgery resection and protontherapy to management paediatric craniopharyngioma. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Craniopharyngioma
- What is being tested?
- Protontherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2010to 2 Feb 2021
- Phase
- Phase 2
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Histologically documented craniopharyngioma
- Age range between 3 and 16 years
- Landsky performance status > 60
- Incomplete surgical resection or simple biopsy
- Solid and/or cystic aspect on imaging
- Irradiation performed at the time of presentation or of local progression
- Signed informed consent by parents or by legal representative (with copy to each participating center)
Who cannot join
- Previous history of radiotherapy (including stereotactic) administered to the head and neck region
- Severe vasculopathy
- Participation to a concurrent study
- Contra-indication to general anesthesia in children below 5 years
- Patient non-compliant to a minimum 30 mn immobilisation
- Patient deprived of freedom or under guardianship
- Patient not expected to be followed in a long run
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut Curie
Paris, 75005
Groupe Hospitalier Necker Enfants Malades
Paris, 75015
Gustave Roussy
Villejuif, 94800
About this study
Official title: Phase II Study on the Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy
Prospective, open labelled, phase II, monocenter trial to combine partial surgery resection and protontherapy to management paediatric craniopharyngioma.
Read the detailed description
This study is phase II prospective, open labelled, phase ii, monocenter. The main objective is to evaluate the fractionated high precision radiotherapy with a dose of 59,5 Gy (1,7 Gy daily, 5 fractions per week).
- Conditions
- Craniopharyngioma
- Being tested
- Protontherapy
- Keywords
- craniopharyngioma, protontherapy
- Medical subject headings
- Craniopharyngioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProtontherapyRadiation
59,5 Gy (1,7 Gy daily, 5 fractions per week).
| Study group | Role | What they receive |
|---|---|---|
| Protontherapy | Experimental | Not described Receives: Radiation: Protontherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy
Measured: at 3 years
Secondary outcomes (1)
visual pathway tolerance according to NCI-CTC v3.0 scale
Measured: through study completion, up to 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startMar 2010
- Primary completion13 Nov 2018
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniopharyngiomaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842723
- Sponsor's protocol ID
- IC 2008-01
- Status last verified
- Jan 2024
- First submitted
- 11 Jul 2016
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study on the Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy
- ClinicalTrials.gov ID
- NCT02842723
- Acronym / sponsor ID
- IC 2008-01
- Conditions
- Craniopharyngioma
- Keywords
- craniopharyngioma, protontherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- Mar 2010 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 25 Jul 2016 (estimated)
- 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.
Prospective, open labelled, phase II, monocenter trial to combine partial surgery resection and protontherapy to management paediatric craniopharyngioma.
Detailed description
This study is phase II prospective, open labelled, phase ii, monocenter. The main objective is to evaluate the fractionated high precision radiotherapy with a dose of 59,5 Gy (1,7 Gy daily, 5 fractions per week).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protontherapy | Experimental | Radiation: Protontherapy |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Histologically documented craniopharyngioma
- Age range between 3 and 16 years
- Landsky performance status > 60
- Incomplete surgical resection or simple biopsy
- Solid and/or cystic aspect on imaging
Key exclusion criteria (7 listed)
- Previous history of radiotherapy (including stereotactic) administered to the head and neck region
- Severe vasculopathy
- Participation to a concurrent study
- Contra-indication to general anesthesia in children below 5 years
- Patient non-compliant to a minimum 30 mn immobilisation
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 |
|---|---|---|
| Protontherapy59,5 Gy (1,7 Gy daily, 5 fractions per week). | Radiation | Protontherapy |
Primary outcome
local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy
Time frame: at 3 years
1 secondary outcome
visual pathway tolerance according to NCI-CTC v3.0 scale
Time frame: through study completion, up to 9 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Protontherapy in people with Craniopharyngioma, run by Institut Curie at 3 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 7 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: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy (time frame: at 3 years). 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 31 Jan 2024.