Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors

Not Applicable

Recruiting

• Conditions: Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma
• Interventions: Radiation: Carbon ions therapy; Radiation: Advanced external radiotherapy by Xrays or protons

• Registration Number: NCT02838602
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-20
• Study Start: 2017-12-23
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-02
• Primary Completion: 2026-12-23
• Study Completion: 2026-12-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbon ions therapy	Carbon ions therapy	Radical and exclusive carbon ions radiotherapy
Conventional radiotherapy	Advanced external radiotherapy by Xrays or protons	Radical radiotherapy by Xrays and / or protons

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	up to 5 years or loss of follow-up	Starting point for PFS measurement is the randomization date

Secondary Outcome Measures

Name	Time	Method
Local progression free survival	up to 5 years or loss of follow-up	takes account of the local progression of the tumor in the planning target volume (PTV)
Grades of the CTCAE-V4.02 classification	up to 5 years or loss of follow-up	Tolerance
EQ-5D questionnaire	up to 5 years or loss of follow-up	Quality of life
Metastases free survival	up to 5 years or loss of follow-up	takes account of any site of relapse outside of the PTV
Overall survival	up to 5 years or loss of follow-up	delay of death of any cause accounted starting from randomization

Trial Locations

Locations (21)

Radiothérapie, Hôpital A. Michallon, CHU de Grenoble; 🇫🇷 Grenoble, France

Radiothérapie, CRLCC GF Leclerc; 🇫🇷 Dijon, France

Radiothérapie, Institut Gustave Roussy; 🇫🇷 Villejuif, France

Institut Curie, site Hôpital de Paris et site d'Orsay (Centre de protonthérapie); 🇫🇷 Paris, France

Radiothérapie, CHU Pitié-Salpétrière; 🇫🇷 Paris, France

Radiothérapie, CRLCC Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Radiothérapie, CRLCC René Gauducheau; 🇫🇷 Saint-Herblain, France

Institut universitaire du cancer de Toulouse - Oncopole, Institut Claudius Regaud; 🇫🇷 Toulouse, France

Radiothérapie, CRLCC Oscar Lambret; 🇫🇷 Lille, France

Radiothérapie, Institut de Cancérologie de Lorraine Alexis Vautrin; 🇫🇷 Vandœuvre-lès-Nancy, France

Radiothérapie, CRLCC Léon Bérard; 🇫🇷 Lyon, France

Radiothérapie, CRLCC Institut Paoli Calmettes; 🇫🇷 Marseille, France

Radiothérapie, Hôpital de Haut Lévêque, CHU Bordeaux; 🇫🇷 Pessac, France

Radiothérapie, Institut de Cancérologie de la Loire Lucien Neuwirtz; 🇫🇷 St Priest en Jarez, France

CHU Amiens - Hôpital Sud; 🇫🇷 Amiens, France

Radiothérapie, CLCC François Baclesse; 🇫🇷 Caen, France

Pôle de radiothérapie, Centre Antoine-Lacassagne; 🇫🇷 Nice, France

Radiothérapie, Institut Régional du Cancer Montpellier, ICM Val d'Aurelle; 🇫🇷 Montpellier, France

Radiothérapie, CRLCC Institut Jean Godinot; 🇫🇷 Reims, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Radiothérapie, CRLCC Paul Strauss; 🇫🇷 Strasbourg, France