An observational study in Cancer, Cystic Carcinomas, Adenoid and Soft-tissue Sarcomas, sponsored by Hospices Civils de Lyon. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by Hospices Civils de Lyon · Observational
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 62 is below the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Patients covered by the French Assurance Maladie from 2010 onwards for carbonetherapy treatment outside the PHRC-ETOILE programme
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 :
Exclusion Criteria:
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).
Other: Questionnaire
For patients alive only at the time of inclusion, completion of a quality-of-life questionnaire and a medico-economic interview (prospective).
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.
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
Plan to share: 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.
No publications or documents are linked to this record.
Ran from May 2025 to primary completion in Jul 2025, 1 month.
Of 1,098 non-industry observational studies under Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 227. This study's 1 month is below that.
Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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