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Compares treatment options for Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and...
Official title Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors
ClinicalTrials.gov ID: NCT02838602
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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...
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Caen, France
- Clermont-Ferrand, France
- Dijon, France
- Grenoble, France
- Lille, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nice, France
- Paris, France
- Pessac, France
- Reims, France
- Rennes, France
- Saint-Herblain, France
- Saint-Priest-en-Jarez, France
- Strasbourg, France
- Toulouse, France
- Vandœuvre-lès-Nancy, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Caen, France; Clermont-Ferrand, France; Dijon, France; Grenoble, France; Lille, France and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.