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

NCT06535997 | Completed

• 1 other identifier: 69HCL24_0473
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 2

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

Keywords

Cancer; carbonetherapy; descriptive cohort

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (1)

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).

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Patients traited for carbonetherapy outside the PHRC-ETOILE programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients covered by the French Assurance Maladie from 2010 onwards for carbonetherapy treatment outside the PHRC-ETOILE programme

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• Centre François Baclesse, Centre de lutte contre le cancer (CLCC): collaborator

Study Sites (2)

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

Caen, 14076, France

Location

Hôpital Michallon, CHU de Grenoble-Alpes

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Neoplasms; Carcinoma, Adenoid Cystic; Sarcoma; Osteosarcoma; Chondrosarcoma; Lymphoma, Follicular; Chordoma; Hemangiosarcoma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Germ Cell and Embryonal; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: August 2, 2024
• Study Start: May 23, 2025
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

FR (2)