Patients must have histologically confirmed diagnosis of bone sarcoma (osteosarcoma, Ewing sarcoma of bone, chondrosarcoma or chordoma)
Patients with confirmed disease progression and metastatic disease not amenable to surgical resection or radiation with the intent to cure the disease
Patients must have at least one prior treatment, but no more than two prior chemotherapies for metastatic disease for osteosarcoma, chondrosarcoma and Ewing sarcoma. Previously untreated chordoma patients or chordoma patients with 1 or 2 prior chemotherapies or targeted therapies, but no more than 2 prior lines of treatment.
Overall health status of the patient has to be good (ECOG performance status < 2)
Adequate function of bone marrow, liver and kidneys and normal organ function
WHAT is the key question that this trial is attempting to answer?
This study assesses the safety and efficacy of regorafenib in patients with metastatic bone sarcomas.
WHY patients might want to participate?
This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in bone sarcomas and potentially help other patients with these diseases. The trial might or might not have benefit in your individual case.
WHEN will the trial be open?
The study is open (recruiting)
WHERE is the trial available?
The trial is available in several study centers in France.
For a complete list of trial locations, please see here.
Study contacts:
Jessy DELAYE Phone: +33 (0)144230404 E-Mail: Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.
STUDY DESIGN: What does the study look like?
There will be 2 study arms (groups): all participating patients will be randomly divided (by a computer) in two groups. Two thirds of the patients will be assigned to regorafenib, the other group (one third of the patients) will receive placebo.
The study has 4 cohorts: Ewing Sarcomas, Chondrosarcomas, Osteosarcomas and Chondromas.
Regorafenib will be given at a dose of 160mg once a day, 3 weeks on / 1 week off. Patients, who might progress on placebo can receive/cross-over to the regorafenib arm.
HOW do I get more information?
Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving GIST and/or sarcoma patients. If there are no such organisation in your country, please email us for more information: Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.
SHARE your experience
You want to share your experience on this trial? Send us an e-mail to: Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo. Note that your experience would be helpful for other patients and patient organisations.
RESULTS of the study
No results are available at this time. Future results will be linked here.
Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.
Merken
Targeted Therapies
New insights from molecular biology and biomedicine reveal certain features and characteristics of malignant cells which can be targeted by the development of new, specific drugs. For example, cancer cells usually show changes in their genetic material (= mutations) which lead to altered protein structures where either the cause can be inhibited or the effect can be treated.
Since these characteristics do not (or only rarely) show up in normal cells, targeted therapy specifically fights cancer cells and spares healthy cells. This approach usually makes it both effective and less toxic than chemotherapy.
Osteosarcoma
Osteosarcoma is a cancerous tumor that occurs in the bone. Osteosarcoma is a primary bone cancer. That means the cancer originates in the bone itself.
Most osteosarcomas appear in the long bones of the body, such as the femur (the thigh bone), the tibia (the shinbone) or the humerus (the bone that runs from the shoulder to the elbow), although they can appear in any bones.
Osteosarcoma is the oldest cancer known to man. A fossilized humanoid foot found in South Africa is 1.7m years old and it had osteosarcoma.
Resection
Resection refers to the complete or partial removal of an organ or of tissue during an operation. Tumor resections are divided into the following levels:
R0 resection: Removal of the entire tumor including a rim of normal tissue around it. Using a microscope the pathologist can not find any trace of the tumor around the resection area.
R1 resection: The tumor is macroscopically removed. Pathology shows tumor residue around the resection area.
R2 resection: Tumor tissue can still be seen on the margins of the resection area by the naked eye. In some cases, surgeons cannot fully remove the whole tumor due to its size or location without harming other organs or tissues too much.
GIST
Gastrointestinal stromal tumor (GIST) affects the digestive tract or nearby structures within the abdomen. The most common location is the stomach. GI stromal tumor, or GIST cancer, is a sarcoma.
