CancerPRIMHADRONNCT06535997
Descriptive Cohort of French Patients Treated With Carbonetherapy Since October 2010 Outside PHRC-ETOILE
An observational study of Cancer and Cystic Carcinomas, Adenoid, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Since the 1990s, carbonetherapy radiotherapy has been developed in a few sites around the world, mainly to treat inoperable and highly radioresistant tumors. In the absence of a treatment center of this type in France, the French health insurance system and health authorities (DGOS, INCa and HAS) have contributed to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cystic Carcinomas, Adenoid, Soft-tissue Sarcomas
- What is being tested?
- Questionnaire
- How many people
- 62 participants
- Where
- 2 sitesFrance
- Study dates
- 23 May 2025to 14 Jul 2025
- 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 covered by the French Assurance Maladie from 2010 onwards for carbonetherapy treatment outside the PHRC-ETOILE programme
Who may be able to join
- Patients aged ≥ 18 years at the time of inclusion
- Patients treated with Carbonetherapy outside PHRC-ETOILE from October 2010 to December 2023, after validation of their file by the health insurance expert, under an agreement providing for reimbursement for indications similar to those of PHRC-ETOILE for patients unable or unwilling to be included (re-irradiation, rare tumors or tumors of exceptional presentation not included in PHRC-ETOILE inclusion criteria). These include, by way of illustration :
- Unresectable or non-operable cancers, or those with macroscopically incomplete resection (R2)
- Radiation-resistant cancers considered eligible according to the following indicative list:
- Cystic adenoid carcinomas (CAK) of the head and neck (excluding laryngeal and tracheal localizations)
- Soft-tissue sarcomas
Show all 13Show fewer
- Pleiomorphic rhabdomyosarcomas only
- Retroperitoneal sarcomas subject to technical feasibilitý - movement)
- Osteosarcomas of any location and any grade
- Chondrosarcomas (skull base excluded) grade greater than 2
- Chordomas of the axial skeleton and pelvis (excluding skull base)
- Angiosarcomas
- Patients who have not objected to the re-use of medical data for cancer research purposes, and who agree to be contacted by the investigator to complete the quality of life and care pathway questionnaires.
Who cannot join
- Refusal by the living patient to participate in research
- Failure to carry out initially planned carbon therapy treatment
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre François Baclesse, Centre de lutte contre le cancer (CLCC)
Caen, 14076
Hôpital Michallon, CHU de Grenoble-Alpes
Grenoble, 38043
About this study
Official title: Descriptive Cohort of French Patients Treated With Carbonetherapy Since October 2010 Outside PHRC-ETOILE - PRIMHADRON
Since the 1990s, carbonetherapy radiotherapy has been developed in a few sites around the world, mainly to treat inoperable and highly radioresistant tumors. In the absence of a treatment center of this type in France, the French health insurance system and health authorities (DGOS, INCa and HAS) have contributed to the setting up of a prospective randomized controlled study, PHRC-ETOILE, to evaluate this practice, and have also authorized, on the basis of expert opinion, treatment outside the PHRC of patients who could not be included in the PHRC but whose indications were very similar to those mentioned in the PHRC.
This "out-of-study" cohort began in October 2010, and has continued to grow steadily. By the end of 2022, it had reached 53 patients.
Read more
It is important to study the impact of carbonetherapy on these patients, in order to gain an initial appreciation of the benefits, tolerability and contribution of this practice for patients.
Local control, progression-free survival and overall survival in this cohort will be studied, as well as the role of carbon therapy in the management of these patients, some of whom are very complex. Complications attributable to carbon therapy, care pathways and changes in patients' quality of life will also be analyzed.
This analysis will make a contribution to the overall evaluation of carbonetherapy, assessing its usefulness and therefore the benefit to patients of its application. In our future prospects, some of these cases (around 23) could be used to consolidate the PHRC-ETOILE cohort.
This study will contribute to the development of the case for carbonetherapy, enabling the health authorities to make an informed decision on whether or not to expand access to this therapy.
- PHRC-ETOILE (First Transnational Randomized Prospective Trial Comparing Carbon Therapy versus Non-Carbon Therapy for Radioresistant Tumors)
- PHRC (Hospital clinical research programme)
- Conditions
- Cancer, Cystic Carcinomas, Adenoid, Soft-tissue Sarcomas, Rhabdomyosarcoma Pleomorphic, Sarcoma,Soft Tissue, Osteosarcomas
- Being tested
- Questionnaire
- Keywords
- Cancer, carbonetherapy, descriptive cohort
- Medical subject headings
- Neoplasms, Carcinoma, Adenoid Cystic, Sarcoma, Osteosarcoma, Chondrosarcoma, Lymphoma, Follicular, Chordoma, Hemangiosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
For patients alive only at the time of inclusion, completion of a quality-of-life questionnaire and a medico-economic interview (prospective).
| Study group | Role | What they receive |
|---|---|---|
| Patients traited for carbonetherapy outside the PHRC-ETOILE programme | Collection of clinical-biological data from medical records (retrospective). For patients alive, completion of a quality-of-life questionnaire and a medico-economic interview (prospective). Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Defined as the time elapsed between the start of carbonbased therapy and the date of the first event, i.e. 1st progression, 1st relapse or death (whatever the cause). Patients with no events by 12/31/2023 will be censored at the date of their last known tumor evaluation.
Measured: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start23 May 2025
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Centre François Baclesse, Centre de lutte contre le cancer (CLCC)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535997
- Sponsor's protocol ID
- 69HCL24_0473
- Acronym
- PRIMHADRON
- Status last verified
- Aug 2025
- First submitted
- 12 Jul 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No final decision has been made yet regarding IPD sharing. The sponsor is currently reviewing institutional policies, data protection requirements and publication strategies. A plan may be implemented in the future depending on scientific interest and feasibility.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Cohort of French Patients Treated With Carbonetherapy Since October 2010 Outside PHRC-ETOILE - PRIMHADRON
- ClinicalTrials.gov ID
- NCT06535997
- Acronym / sponsor ID
- PRIMHADRON / 69HCL24_0473
- Conditions
- Cancer, Cystic Carcinomas, Adenoid, Soft-tissue Sarcomas, Rhabdomyosarcoma Pleomorphic, Sarcoma,Soft Tissue, Osteosarcomas
- Keywords
- Cancer, carbonetherapy, descriptive cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Centre François Baclesse, Centre de lutte contre le cancer (CLCC)
- Study start
- 23 May 2025 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 2 Aug 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.
Since the 1990s, carbonetherapy radiotherapy has been developed in a few sites around the world, mainly to treat inoperable and highly radioresistant tumors. In the absence of a treatment center of this type in France, the French health insurance system and health authorities (DGOS, INCa and HAS) have contributed to the setting up of a prospective randomized controlled study, PHRC-ETOILE, to evaluate this practice, and have also authorized, on the basis of expert opinion, treatment outside the PHRC of patients who could not be included in the PHRC but whose indications were very similar to those mentioned in the PHRC.
This "out-of-study" cohort began in October 2010, and has continued to grow steadily. By the end of 2022, it had reached 53 patients.
It is important to study the impact of carbonetherapy on these patients, in order to gain an initial appreciation of the benefits, tolerability and contribution of this practice for patients.
Local control, progression-free survival and overall survival in this cohort will be studied, as well as the role of carbon therapy in the management of these patients, some of whom are very complex. Complications attributable to carbon therapy, care pathways and changes in patients' quality of life will also be analyzed.
This analysis will make a contribution to the overall evaluation of carbonetherapy, assessing its usefulness and therefore the benefit to patients of its application. In our future prospects, some of these cases (around 23) could be used to consolidate the PHRC-ETOILE cohort.
This study will contribute to the development of the case for carbonetherapy, enabling the health authorities to make an informed decision on whether or not to expand access to this therapy.
- PHRC-ETOILE (First Transnational Randomized Prospective Trial Comparing Carbon Therapy versus Non-Carbon Therapy for Radioresistant Tumors)
- PHRC (Hospital clinical research programme)
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients traited for carbonetherapy outside the PHRC-ETOILE programme | – | Other: QuestionnaireCollection of clinical-biological data from medical records (retrospective). For patients alive, completion of a quality-of-life questionnaire and a medico-economic interview (prospective). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients covered by the French Assurance Maladie from 2010 onwards for carbonetherapy treatment outside the PHRC-ETOILE programme
Key inclusion criteria (13 listed)
- Patients aged ≥ 18 years at the time of inclusion
- Patients treated with Carbonetherapy outside PHRC-ETOILE from October 2010 to December 2023, after validation of their file by the health insurance expert, under an agreement providing for reimbursement for indications similar to those of PHRC-ETOILE for patients unable or unwilling to be included (re-irradiation, rare tumors or tumors of exceptional presentation not included in PHRC-ETOILE inclusion criteria). These include, by way of illustration :
- Patients who have not objected to the re-use of medical data for cancer research purposes, and who agree to be contacted by the investigator to complete the quality of life and care pathway questionnaires.
Key exclusion criteria (2 listed)
- Refusal by the living patient to participate in research
- Failure to carry out initially planned carbon therapy treatment
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 |
|---|---|---|
| QuestionnaireFor patients alive only at the time of inclusion, completion of a quality-of-life questionnaire and a medico-economic interview (prospective). | Other | Patients traited for carbonetherapy outside the PHRC-ETOILE programme |
Primary outcome
Progression-free survival (PFS)
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Defined as the time elapsed between the start of carbonbased therapy and the date of the first event, i.e. 1st progression, 1st relapse or death (whatever the cause). Patients with no events by 12/31/2023 will be censored at the date of their last known tumor evaluation.
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 6 Aug 2025.
- Individual participant dataSharing planned: Undecided. No final decision has been made yet regarding IPD sharing. The sponsor is currently reviewing institutional policies, data protection requirements and publication strategies. A plan may be implemented in the future depending on scientific interest and feasibility.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Cystic Carcinomas, Adenoid, run by Hospices Civils de Lyon at 2 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 13 inclusion and 2 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 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Progression-free survival (PFS) (time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 6 Aug 2025.