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

NCT ID: NCT06535997

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-23
• Study Completion Date: 2025-07-14

Brief 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 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)

Conditions

Cancer; Cystic Carcinomas, Adenoid; Soft-tissue Sarcomas; Rhabdomyosarcoma Pleomorphic; Sarcoma,Soft Tissue; Osteosarcomas; Chondrosarcoma, Grade 3; Chordoma; Angiosarcomas

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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).

Questionnaire

Intervention Type: OTHER

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

Interventions

Questionnaire

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged ≥ 18 years at the time of inclusion

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Caen, , France

Hôpital Michallon, CHU de Grenoble-Alpes

Grenoble, , France

Countries

France

Other Identifiers

69HCL24_0473

Identifier Type: -

Identifier Source: org_study_id