Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Osteosarcoma

Sarcoma, Ewing

Chondrosarcoma

Chondroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Ewing Sarcoma

For adult patients (≥18 years old) : 160 mg/d once daily for the 3 weeks on / 1 week off plus Best Supportive Care (BSC) until progression (according to RECIST 1.1), intolerance or withdrawal of consent .

For children Age ≥10 years to \<18 years old and BSA ≥1.30 m², regorafenib (82 mg/m²) once daily for the 3 weeks on/1 week off (without exceeding 160 mg/day) plus Best Supportive care (BSC) until progression (according to RECIST 1.1), intolerance or withdrawal of consent.

Placebo plus BCS until progression (according to RECIST V1.1) intolerance or withdrawal of consent. Patients who have received placebo will receive open-label regorafenib after objective tumor progression.

For adults patients and children with BSA ≥1.70 m² : 4 tablets once daily until progression or unacceptable toxicity For children with BSA ≥1.30 and ≤1.69 m² : 3 tablets once daily until progression or unacceptable toxicity

Regorafenib

For adults patients and children with BSA ≥1.70 m² : 4 tablets once daily and switch to regorafenib after confirmed progression For children with BSA ≥1.30 and ≤1.69 m² : 3 tablets once daily and switch to regorafenib after confirmed progression

Placebo

Sabrina YARA

Elsa KALBACHER, MD

Antoine ITALIANO, MD

Corinne DELCAMBRE, MD

Alice HERVIEU, MD

Nicolas PENEL, MD

Jean Yves BLAY, MD PhD

François BERTUCCI, MD PhD

Florence DUFFAUD, MD PhD

Didier CUPISSOL, MD

Antoine THYSS, MD PhD

Pascaline BOUDOU-ROUQUETTE, MD

Sophie PIPERNO-NEUMANN, MD

Christophe PERRIN, MD

Emmanuelle BOMPAS, MD

Olivier COLLARS, MD

Christine CHEVREAU, MD

Helene VEGAS, MD

Maria RIOS, MD

Olivier MIR, MD

INDICATION:

Metastatic bone sarcomas: conventional high grade osteosarcoma, Ewing sarcoma of bone, intermediate or high-grade chondrosarcomas and chordomas and either bone or soft tissue metastatic CIC-rearranged sarcomas

METHODOLOGY:

Randomized, placebo-controlled, multicentric, phase II study -This is a double-blind placebo-controlled trial, with 5 cohorts: cohort A: Osteosarcoma, cohort B: Ewing sarcoma, cohort C: Chondrosarcoma, cohort D : chondroma, cohort E: CIC-rearranged sarcoma. Cohort A, B and C will involve a total of 36 patients (24 Regorafenib + 12 placebo), cohort D a total of 24 evaluable patients (16 Regorafenib + 8 placebo) and cohort E will involve a total of 27 evaluable patients (18 Regorafenib + 9 placebo).

159 patients who meet the eligibility criteria will be randomly assigned in a 2:1 ratio to the following treatment groups :

The Arm A:

Regorafenib (160 mg/d) once daily for the 3 weeks on / 1 week off plus Best Supportive Care (BSC) until progression (according to RECIST 1.1), intolerance or withdrawal of consent .

Patients receiving regorafenib who experience disease progression and for whom in the investigator opinion, treatment with regorafenib is providing clinical benefit, may continue the treatment following consultation with the study coordinator and the sponsor.

The Arm B:

Placebo plus BSC until progression (according to RECIST V1.1) intolerance or withdrawal of consent. Patients who have received placebo will receive open-label regorafenib after objective tumor progression.

Patients will be stratified at randomization according to histology .

A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas

A Randomized Phase II, Placebo-controlled, Multicenter Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas

Proportion of patients without disease progression at the defined timepoint after central radiological review (using RECIST 1.1)

from the date of randomization until the date of radiological progression or death whatever the cause (if death occurs before progression)

complete response (CR) or partial response (PR) according to RECIST 2009, version 1.1, for all cohorts, and CHOI criteria for chordoma

from the date of randomization until the date of death due to any cause

objective response of CR or PR, whichever is noted earlier, to first disease progression or death before progression

the proportion of patients without progression at 3 and 6 months post randomization

from date of randomization until the date of first observation of progression

ratio of time to PD under regorafenib to TTP under previous treatment

according to NCI-CTCAE V4-0 (National Cancer Institut Common Terminology Criteria for Adverse Events)

Progression Free Survival according to Choi criteria for Chordoma

UNICANCER

Musculoskeletal Diseases

Bone Neoplasms

Enchondroma

comparison of two different tumors treated by curettage

curettage (intralesional surgery)

Davide Donati, MD

The purpose of this project is to verify possible clinical and radiological findings with regard to distinguishing enchondroma from low grade chondrosarcoma of the long bones. In addition, this study presents the outcome of patients with enchondroma and low grade chondrosarcoma of the long bones who were treated with curettage (intralesional surgery).

The investigators retrospectively review the records of 65 patients with enchondroma and 37 patients with low grade chondrosarcoma of the limbs treated by curettage between 1988 and 2014 in a single Institution.

Low Grade Chondrosarcoma Versus Enchondroma

Low Grade Chondrosarcoma Versus Enchondroma: Challenges in Diagnosis and Management

publish a paper in international medical journal

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas	NCT02389244	Ewing Sarcomas Chondrosarcomas Osteosarcomas Chondroma CIC-Rearranged ...	Regorafenib Placebo	10 Years -	UNICANCER
Low Grade Chondrosarcoma Versus Enchondroma	NCT02996747	Chondroma Chondrosarcoma	curettage (intr...	-	Istituto Ortopedico Rizzoli
A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas	NCT02389244	Ewing Sarcomas Chondrosarcomas Osteosarcomas Chondroma CIC-Rearranged ...	Regorafenib Placebo	10 Years -	UNICANCER

Spots Global Cancer Trial Database for chondroma

Every month we try and update this database with for chondroma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for chondroma

Every month we try and update this database with for chondroma cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for chondroma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.