Descriptive Cohort of French Patients Treated With Carbonetherapy Since October 2010 Outside PHRC-ETOILE

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)

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Key information

Conditions

Cancer Adenocarcinoma Angiosarcomas Carcinoma Carcinoma, Adenoid Cystic Chondrosarcoma Chondrosarcoma, Grade 3 Chordoma Cystic Carcinomas, Adenoid Hemangiosarcoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Vascular Tissue Osteosarcoma Osteosarcomas Rhabdomyosarcoma Pleomorphic Sarcoma Sarcoma,Soft Tissue Soft-tissue Sarcomas

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre François Baclesse, Centre de lutte contre le cancer (CLCC), Caen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
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.

Exclusion criteria

Refusal by the living patient to participate in research
Failure to carry out initially planned carbon therapy treatment

Treatment and study plan

Questionnaire

Other

For patients alive only at the time of inclusion, completion of a quality-of-life questionnaire and a medico-economic interview (prospective).

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

Centre François Baclesse, Centre de lutte contre le cancer (CLCC)

Registry information

Official study title

Descriptive Cohort of French Patients Treated With Carbonetherapy Since October 2010 Outside PHRC-ETOILE - PRIMHADRON

Acronym: PRIMHADRON

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Aug 2, 2024
Registry last updated: Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed