Actively Recruiting
Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors
Led by Hospices Civils de Lyon · Updated on 2021-09-02
250
Participants Needed
21
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a transnational prospective randomized trial comparing definitive carbon ion therapy versus photon or combined photon and protontherapy as standard treatment for unresectable or macroscopically uncompleted resected radioresistant tumors. Eligible tumors are axial chordoma (except of base of skull), adenoid cystic carcinoma of head and neck (except of trachea) and sarcomas of any site (except chondrosarcoma of the skull base), non previously irradiated and without pre-planned surgery or chemotherapy after the clinical trial procedure. Randomization is balanced 1 for 1. Patients of the experimental arm are treated in carbon ions centers in Europe and patients of the standard arm are treated in France in their closest participating radiotherapy center. An accrual of 250 patients is needed and an absolute difference of 20% of relapse free survival at five years is awaited. The main endpoint is the progression free survival at five years. The trial is supported by the French program of clinical research and the national health insurance. Two associated studies are carried out: a radiobiological one looking for radioresistance markers in the sarcomas biopsies, and the second one is about medico economics.
CONDITIONS
Official Title
Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- No severe comorbidities and life expectancy over 10 years
- Tumor that is unresectable, inoperable, or incompletely resected (R2 resection)
- Diagnosed with eligible radioresistant tumors including adenoid cystic carcinoma of head and neck (excluding larynx and trachea), soft tissue sarcoma, pleomorphic rhabdomyosarcoma (excluding alveolar and embryonal forms), retroperitoneal sarcoma if technically feasible, osteosarcoma of any grade and location (excluding Ewing sarcoma), chondrosarcoma (grade 2 or higher, excluding skull base), axial skeleton or pelvic chordoma (excluding skull base), or angiosarcoma
- No epidermal invasion of the tumor (hypodermic invasion allowed with skin fixation but no true epidermal permeation)
- Planned treatment volume (PTV) less than 25 cm
- ECOG Performance Status 0 to 2 or Karnovsky index 60 or higher
- Not pregnant and no possibility of pregnancy during treatment
- Have health insurance
- Provide signed informed consent
- Confirmed indication for carbon ion therapy assessed by medical team and able to start treatment within two months of registration
You will not qualify if you...
- Complete tumor removal by surgery (R0 or R1 resection)
- Previous radiation therapy in the treatment area
- Presence of metastatic disease
- Disease not suitable for curative treatment, such as rapidly progressing disease resistant to medical treatment especially for sarcoma
- Any contraindication to radiation therapy by X-ray or particle therapy
- Planned surgery or chemotherapy after radiotherapy without sufficient spacing (except if spacer can be inserted)
- Presence of permanent metallic material in the treatment area (carbon fiber materials allowed)
- History of concurrent cancers except in situ cervical carcinoma, cured basal cell skin cancer, or any cured cancer with no relapse for 5 years
- Unable to commit to follow-up for 5 years
AI-Screening
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Trial Site Locations
Total: 21 locations
1
CHU Amiens - Hôpital Sud
Amiens, France, 80054
Actively Recruiting
2
Radiothérapie, CLCC François Baclesse
Caen, France, 14076
Actively Recruiting
3
Radiothérapie, CRLCC Jean Perrin
Clermont-Ferrand, France, 63011
Not Yet Recruiting
4
Radiothérapie, CRLCC GF Leclerc
Dijon, France, 21034
Actively Recruiting
5
Radiothérapie, Hôpital A. Michallon, CHU de Grenoble
Grenoble, France, 38043
Actively Recruiting
6
Radiothérapie, CRLCC Oscar Lambret
Lille, France, 59020
Actively Recruiting
7
Radiothérapie, CRLCC Léon Bérard
Lyon, France, 69373
Actively Recruiting
8
Radiothérapie, CRLCC Institut Paoli Calmettes
Marseille, France, 13009
Not Yet Recruiting
9
Radiothérapie, Institut Régional du Cancer Montpellier, ICM Val d'Aurelle
Montpellier, France, 34298
Actively Recruiting
10
Pôle de radiothérapie, Centre Antoine-Lacassagne
Nice, France, 06189
Actively Recruiting
11
Radiothérapie, CHU Pitié-Salpétrière
Paris, France, 75013
Not Yet Recruiting
12
Institut Curie, site Hôpital de Paris et site d'Orsay (Centre de protonthérapie)
Paris, France, 75231
Not Yet Recruiting
13
Radiothérapie, Hôpital de Haut Lévêque, CHU Bordeaux
Pessac, France, 33604
Not Yet Recruiting
14
Radiothérapie, CRLCC Institut Jean Godinot
Reims, France, 51726
Actively Recruiting
15
Centre Eugene Marquis
Rennes, France, 35000
Not Yet Recruiting
16
Radiothérapie, CRLCC René Gauducheau
Saint-Herblain, France, 44805
Not Yet Recruiting
17
Radiothérapie, Institut de Cancérologie de la Loire Lucien Neuwirtz
Saint-Priest-en-Jarez, France, 42270
Actively Recruiting
18
Radiothérapie, CRLCC Paul Strauss
Strasbourg, France, 67065
Actively Recruiting
19
Institut universitaire du cancer de Toulouse - Oncopole, Institut Claudius Regaud
Toulouse, France, 31059
Actively Recruiting
20
Radiothérapie, Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
21
Radiothérapie, Institut Gustave Roussy
Villejuif, France, 94805
Not Yet Recruiting
Research Team
P
Pascal POMMIER, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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