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Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors

Sponsor: Hospices Civils de Lyon · NCT02838602 on ClinicalTrials.gov ↗

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Conditions studied

Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma

What it tests

  • Carbon ions therapyradiation
  • Advanced external radiotherapy by Xrays or protonsradiation

Where it's running21 sites

21 international sites

  • CHU Amiens - Hôpital Sud

    Amiens, France 80054

    Recruiting now
    • Claude KRZISCH, MD(contact)
    • Claude KRZISCH, MD(principal investigator)

  • Radiothérapie, CLCC François Baclesse

    Caen, France 14076

    Recruiting now
    • Juliette THARIAT, MD(contact)
    • Juliette THARIAT, MD(principal investigator)
    • Dinu STEFAN, MD(sub investigator)
    • Delphine LEROUGE, MD(sub investigator)
    • Bernard GERY, MD(sub investigator)
    • Laura MOISE, MD(sub investigator)
    • Sabine NOAL, MD(sub investigator)
    • Jacques BALOSSO, MD(sub investigator)

  • Radiothérapie, CRLCC Jean Perrin

    Clermont-Ferrand, France 63011

    Opening soon
    • Fanny MARTIN(contact)
    • Fanny MARTIN, MD(principal investigator)
    • Michel LAPEYRE, MD(sub investigator)
    • Jessica MIROIR, MD(sub investigator)

  • Radiothérapie, CRLCC GF Leclerc

    Dijon, France 21034

    Recruiting now
    • Gilles TRUC, MD(contact)03.80.73.75.18
    • Gilles TRUC, MD(principal investigator)
    • Noémie VULQUIN, MD(sub investigator)
    • David THIBOUW, MD(sub investigator)
    • Caroline AMOYAL, MD(sub investigator)

  • Radiothérapie, Hôpital A. Michallon, CHU de Grenoble

    Grenoble, France 38043

    Recruiting now
    • Camille, Olivier VERRY, MD(contact)04.76.76.54.35
    • Camille, Olivier VERRY, MD(principal investigator)
    • Julie VILLA, MD(sub investigator)
    • Jacques BALOSSO, MD(sub investigator)
    • Carole IRIART, MD(sub investigator)
    • Violaine BRUN-BARONNAT, MD(sub investigator)

  • Radiothérapie, CRLCC Oscar Lambret

    Lille, France 59020

    Recruiting now
    • Xavier MIRABEL, MD(contact)03.20.29.55.98
    • Xavier MIRABEL, MD(principal investigator)
    • Raphaëlle MOUTTET-AUDOUARD, MD(sub investigator)
    • Abel CORDOBA, MD(sub investigator)
    • Xavier LIEM, MD(sub investigator)
    • David PASQUIER, MD(sub investigator)

  • Radiothérapie, CRLCC Léon Bérard

    Lyon, France 69373

    Recruiting now
    • Pascal POMMIER, MD(contact)(0)4 78 78 51 66[email protected]
    • Pascal POMMIER, MD(principal investigator)
    • Marie-Pierre SUNYACH, MD(sub investigator)
    • Vincent GREGOIRE, MD(sub investigator)

  • Radiothérapie, CRLCC Institut Paoli Calmettes

    Marseille, France 13009

    Opening soon
    • Laurence MOUREAU-ZABOTTO, MD(contact)04.91.22.36.37
    • Laurence MOUREAU-ZABOTTO, MD(principal investigator)

  • Radiothérapie, Institut Régional du Cancer Montpellier, ICM Val d'Aurelle

    Montpellier, France 34298

    Recruiting now
    • Pierre BOISSELIER, MD(contact)
    • Pierre BOISSELIER, MD(principal investigator)

  • Pôle de radiothérapie, Centre Antoine-Lacassagne

    Nice, France 06189

    Recruiting now
    • Alexander FALK, MD(contact)
    • Alexander FALK, MD(principal investigator)
    • Jérôme DOYEN, MD(sub investigator)
    • Pierre-Yves BONDIAU, MD(sub investigator)
    • Karen BENEZERY, MD(sub investigator)

  • Radiothérapie, CHU Pitié-Salpétrière

    Paris, France 75013

    Opening soon
    • Loïc FEUVRET(contact)01.42.17.81.71
    • Loïc FEUVRET, MD(principal investigator)

  • Institut Curie, site Hôpital de Paris et site d'Orsay (Centre de protonthérapie)

    Paris, France 75231

    Opening soon
    • Rémi DENDALE, MD(contact)
    • Rémi DENDALE, MD(principal investigator)
    • Claire ALAPETITE, MD(sub investigator)

  • Radiothérapie, Hôpital de Haut Lévêque, CHU Bordeaux

    Pessac, France 33604

    Opening soon
    • Charles DUPIN, MD(contact)
    • Charles DUPIN, MD(principal investigator)
    • Huchet AYMERI, MD(sub investigator)

  • Radiothérapie, CRLCC Institut Jean Godinot

    Reims, France 51726

    Recruiting now
    • Stéphanie SERVAGI-VERNAT, MD(contact)
    • Stéphanie SERVAGI-VERNAT, MD(principal investigator)

  • Centre Eugene Marquis

    Rennes, France 35000

    Opening soon
    • Joël CASTELLI, MD(contact)
    • Joël CASTELLI, MD(principal investigator)

  • Radiothérapie, CRLCC René Gauducheau

    Saint-Herblain, France 44805

    Opening soon
    • Augustin MERVOYER, MD(contact)02.40.67.99.30
    • Augustin MERVOYER, MD(principal investigator)
    • Nadia WIAZZANE, MD(sub investigator)

  • Radiothérapie, Institut de Cancérologie de la Loire Lucien Neuwirtz

    Saint-Priest-en-Jarez, France 42270

    Recruiting now
    • Nicolas MAGNE, MD(contact)
    • Nicolas MAGNE, MD(principal investigator)
    • Amel REHAILIA-BLANCHARD, MD(sub investigator)
    • Grégoire PIGNE, MD(sub investigator)

  • Radiothérapie, CRLCC Paul Strauss

    Strasbourg, France 67065

    Recruiting now
    • Georges NOEL, MD(contact)03.88.25.24.71
    • Georges NOEL, MD(principal investigator)

  • Institut universitaire du cancer de Toulouse - Oncopole, Institut Claudius Regaud

    Toulouse, France 31059

    Recruiting now
    • Anne DUCASSOU, MD(contact)
    • Anne DUCASSOU, MD(principal investigator)
    • Anne LAPRIE, MD(principal investigator)
    • Martine DELANNES, MD(sub investigator)

  • Radiothérapie, Institut de Cancérologie de Lorraine Alexis Vautrin

    Vandœuvre-lès-Nancy, France 54500

    Recruiting now
    • Guillaume VOGIN, MD(contact)03.83.59.84.27
    • Guillaume VOGIN, MD(principal investigator)
    • Sophie RENARD, MD(sub investigator)

  • Radiothérapie, Institut Gustave Roussy

    Villejuif, France 94805

    Opening soon
    • Cécile LE PECHOUX, MD(contact)01.42.11.42.11
    • Cécile LE PECHOUX, MD(principal investigator)
    • Stéphanie BOLLE, MD(sub investigator)
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Complete macroscopic or microscopic surgical resection (R0 or R1)
* previous irradiation in the volume to be treated
* metastatic disease
* disease not candidate to a curative approach (example accelerated progressive diseaseresistant to nay medical treatment especially for sarcoma)
* 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
* Presence in the target volume of metallic material which cannot be removed (carbon fibres matreial authorized)
* 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))
* impossible follow-up over 5 years

Updated 2021-09-02 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.