NCT06029218

Brief Summary

Thanks to the intrinsic qualities of the proton beam, proton therapy will reduce adverse effects of irradiation. The Proteus®One is the latest generation of proton therapy equipment, enabling the Centre Antoine Lacassagne to expand its range of treatments by carrying out new proton therapy treatments. It has an innovative compact isocentric rotating head (Gantry) that allows the radiation beam to be directed at different angles around the patient. In some cases, two beams are used to treat tumours, and by convention, both beams are delivered during the same session. However, it is necessary to position the patient before each beam, which is time-consuming because 2 beams have to be positioned very precisely each day. The aim of this study is therefore to assess the toxicity of proton therapy delivered by a single daily beam compared with proton therapy delivered by two daily beams, which is the conventional technique.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
66mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Sep 2023Oct 2031

First Submitted

Initial submission to the registry

July 25, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

September 13, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2031

Last Updated

September 25, 2024

Status Verified

August 1, 2024

Enrollment Period

3 years

First QC Date

July 25, 2023

Last Update Submit

September 23, 2024

Conditions

ChordomaChondrosarcomaEwing SarcomaOsteosarcoma

Keywords

protontherapy

Outcome Measures

Primary Outcomes (1)

  • To evaluate the frequency of occurrence of toxicities in the group of patients treated with two daily beams (2DB) and in the group of patients treated with one daily beams (1DB).

    Assessment of the incidence of grade ≥2 medical device-related toxicities assessed according to CTCAE version 5.0 in each of the two treatment arms.

    During 2 to 7 weeks of protontherapy treatment and during 5 years follow-up

Secondary Outcomes (5)

  • Determining the effectiveness of proton therapy

    5-year follow-up visits

  • Determining the effectiveness of proton therapy

    5-year follow-up visits

  • Determining the effectiveness of proton therapy

    5 years follow-up

  • Quality of life assessment

    During 2-7 weeks of protontherapy treatment and during 5 years follow-up

  • Evaluate the time saving between the two arms 1DB and 2DB

    2-7 weeks of protontherapy treatment

Study Arms (2)

1DB

EXPERIMENTAL

One daily Beam treatment

Radiation: Proteus ONE one daily beam

2DB

ACTIVE COMPARATOR

Two daily beam goldstandard

Radiation: Proteus ONE two daily beam

Interventions

Proteus ONE one daily beamRADIATION

A single daily beam is used, doubling the dose delivered for this treatment incidence.

1DB
Proteus ONE two daily beamRADIATION

two daily beams are used, in accordance with the initial treatment plan and the patient's standard of care

2DB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chordoma, chondrosarcoma of the skull base and spine, Ewing's sarcoma, and osteosarcoma meeting the criteria for treatment by proton therapy
  • Tumour requiring 2 beams
  • MRI less than one month old
  • PS 0-2.
  • Patient who has read the patient information note and signed the consent form.
  • Patient with healthcare insurance cover.
  • Age over 18 years.
  • For women of childbearing age, negative urine pregnancy test and effective contraception in place for the duration of treatment and for six months following the end of treatment.

You may not qualify if:

  • Persons deprived of their liberty or under guardianship.
  • Unable to undergo the medical follow-up of the clinical investigation for geographical, social or psychological reasons.
  • Patient eligible for symptom reduction surgery Vulnerable populations and participants defined in Articles 64 to 68 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Antoine lacassagne

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

ChordomaChondrosarcomaSarcoma, EwingOsteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueSarcomaNeoplasms, Bone Tissue

Central Study Contacts

Clement DEVIC, PhD

CONTACT

0492031511clement.devic@nice.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

September 8, 2023

Study Start

September 13, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2031

Last Updated

September 25, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)