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NCT02838602Recruiting

Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors

Transnational Randomized Study Comparing Carbon Ions Therapy Versus Conventional Radiotherapy - Including Protontherapy - for the Treatment of Radioresistant Tumors

Source: ClinicalTrials.gov · Last updated 2 Sept 2021 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
250 (estimated)
First submitted
18 Jul 2016
Start date
Dec 2017
Primary completion date
Dec 2026
Lead sponsor
Hospices Civils de Lyon
Diseases
Sarcoma
NCT number
NCT02838602

What you commit to

  • Study type: Interventional
  • Planned participants: 250
  • From Dec 2017 to the primary completion date, Dec 2026
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Complete macroscopic or microscopic surgical resection (R0 or R1)
  • previous irradiation in the volume to be treated
  • any contra-indication to undergo a radiation therapy by Xray or particle therapy
  • planned surgery or chemotherapy to take place after completion of radiotherapy (example : absence of enough space between an organ risk and the target volume (at least 5 mm) except the possibility of a spacer insertion)
  • planned surgery or chemotherapy after radiotherapy

Other illness

  • metastatic disease
  • disease not candidate to a curative approach (example accelerated progressive diseaseresistant to nay medical treatment especially for sarcoma)
  • history of concomittant (except in situ cervix carcinoma; or any cured basocellular cutaneous cancer tor any cured cancer with no sign of relapse during 5 years))

Other

  • Presence in the target volume of metallic material which cannot be removed (carbon fibres matreial authorized)
  • impossible follow-up over 5 years

Who the study is looking for

  • age ≥ 18 years
  • No severe comorbidity, life expectancy above 10 years
  • Unresectable or inoperable or R2 resection of the tumor
  • Eligible radioresistant tumor according to the limitative list as following:
    • adenoid cystic carcinoma of head and neck (larynx and trachea excluded)
    • soft tissue sarcoma
    • pleomorphic rhabdomyosarcoma only (alveolar and embryonal forms excluded)
    • retroperitoneal sarcoma under condition of technical feasibility (movement)
    • osteosarcoma of any grade and localisation (Ewing excluded)
    • chondrosarcoma (except of skull base) OMS grade \>= 2
    • chordoma axial skeleton or pelvis (except of skull base)
    • angiosarcoma
  • Absence of epidermal invasion (a hypodermic invasion is accepted with fixity of cutaneous plan but not true epidermal permeation)
  • Larger volume to be irradiated (PTV) less than 25 cm
  • ECOG Performance Status ≤ 2 or Karnovsky index ≥ 60
  • no pregnancy of possibility of pregnancy during the treatment
  • having an health insurance
  • signature of a written informed consent
  • validation of the randomization criteria: namely, a carbon ions therapy indication assessed by the medical team of a hadrontherapy center and able to by treated within two month from registration.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU AMIENS - Hôpital Sud
Coordinator of this site? Confirm its status
AmiensFranceRecruiting
Radiothérapie, CLCC François Baclesse
Coordinator of this site? Confirm its status
CaenFranceRecruiting
Radiothérapie, CRLCC Jean Perrin
Coordinator of this site? Confirm its status
Clermont-FerrandFranceNot yet recruiting
Radiothérapie, CRLCC GF Leclerc
Coordinator of this site? Confirm its status
DijonFranceRecruiting
Radiothérapie, Hôpital A. Michallon, CHU de Grenoble
Coordinator of this site? Confirm its status
GrenobleFranceRecruiting
Radiothérapie, CRLCC Oscar Lambret
Coordinator of this site? Confirm its status
LilleFranceRecruiting
Radiothérapie, CRLCC Léon Bérard
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Radiothérapie, CRLCC Institut Paoli Calmettes
Coordinator of this site? Confirm its status
MarseilleFranceNot yet recruiting
Radiothérapie, Institut Régional du Cancer Montpellier, ICM Val d'Aurelle
Coordinator of this site? Confirm its status
MontpellierFranceRecruiting
Pôle de radiothérapie, Centre Antoine-Lacassagne
Coordinator of this site? Confirm its status
NiceFranceRecruiting
Radiothérapie, CHU Pitié-Salpétrière
Coordinator of this site? Confirm its status
ParisFranceNot yet recruiting
Institut Curie, site Hôpital de Paris et site d'Orsay (Centre de protonthérapie)
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ParisFranceNot yet recruiting
Radiothérapie, Hôpital de Haut Lévêque, CHU Bordeaux
Coordinator of this site? Confirm its status
PessacFranceNot yet recruiting
Radiothérapie, CRLCC Institut Jean Godinot
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ReimsFranceRecruiting
Centre Eugène Marquis
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RennesFranceNot yet recruiting
Radiothérapie, CRLCC René Gauducheau
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Saint-HerblainFranceNot yet recruiting
Radiothérapie, Institut de Cancérologie de la Loire Lucien Neuwirtz
Coordinator of this site? Confirm its status
Saint-Priest-en-JarezFranceRecruiting
Radiothérapie, CRLCC Paul Strauss
Coordinator of this site? Confirm its status
StrasbourgFranceRecruiting
Institut universitaire du cancer de Toulouse - Oncopole, Institut Claudius Regaud
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
Radiothérapie, Institut de Cancérologie de Lorraine Alexis Vautrin
Coordinator of this site? Confirm its status
Vandœuvre-lès-NancyFranceRecruiting
Radiothérapie, Institut Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.