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

Not yet recruiting

• Conditions: Cancer; Sarcoma,Soft Tissue; Chordoma; Cystic Carcinomas, Adenoid; Osteosarcomas; Rhabdomyosarcoma Pleomorphic; Soft-tissue Sarcomas; Angiosarcomas; Chondrosarcoma, Grade 3
• Interventions: Other: Questionnaire

• Registration Number: NCT06535997
• Lead Sponsor: Hospices Civils de Lyon

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-31
• Study First Posted: 2024-08-02
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Study Start: 2025-02
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients traited for carbonetherapy outside the PHRC-ETOILE programme	Questionnaire	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).

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	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.

Trial Locations

Locations (2)

Hôpital Michallon, CHU de Grenoble-Alpes; 🇫🇷 Grenoble, France

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