ChondrosarcomaPhase 2CHONRADNCT02008019
A Phase II Study of EVEROLIMUS in Patients With Primary or Relapsed Chondrosarcomas
A Phase 2 study testing Everolimus 2.5 mg/day and Everolimus 10 mg/day in people with Chondrosarcoma, run by Centre Leon Berard at 12 sites in France.
Trial summary
The mainstay of chondrosarcoma treatment is a wide surgical resection. Unfortunately, this is a rare occurrence, and patients with incomplete resection have very poor therapeutic options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chondrosarcoma
- What is being tested?
- Everolimus 2.5 mg/day and Everolimus 10 mg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 12 sitesFrance
- Study dates
- 14 Aug 2014to Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female ≥ 18 years
- Histopathologically confirmed diagnosis of primary or relapsed conventional CHS of the bone (with or without metastases), CHS of any size on MRI if relapse OR size ≥ 10 cm on MRI at diagnosis OR CHS < 10 cm if R0 resection with adequate margins is not feasible at 1st examination (localization, tumor infiltration within surrounding tissues).
- Patient with life expectancy > 6 months
- Planned surgery between D32- D40 after inclusion
- Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2
- No contra-indication to Everolimus as per Summary of Product Characteristics (SPC)
Show all 18Show fewer
- Adequate bone marrow, liver and renal functions including the following:
- Hemoglobin > 9 g/dL
- Neutrophil count ≥ 1500 x 109/L
- Platelets ≥ 100 x 109/L
- Total bilirubin ≤ 1,5x upper limit of normal (ULN)
- Serum Glutamate Oxaloacetate Transaminase (SGOT) and Serum Glutamate Pyruvate Transaminase (SGPT) ≤ 3 x ULN
- Alkaline Phosphatase ≤ 2,5 x ULN
- Serum creatinine < 110 µmol/L or creatinine clearance > 55 ml/min (estimated by Cockcroft Formula)
- Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
- Ability to understand and willingness to sign a written informed consent
- In accordance with French Regulatory Authorities: Patients with French Social Security in compliance with the French law relating to biomedical research (Huriet Law 88-1128 and related decrees)
- Women of child-bearing potential and men must agree to use adequate double contraception prior to study entry, for the duration of study participation and 30 days after the last study drug intake.
Who cannot join
- Mesenchymal, dedifferentiated, clear cell subtype chondrosarcoma, and soft tissues chondrosarcoma
- Tumor tissue sample not available for pathological review/or correlative studies
- Patients may not be receiving any other investigational agents
- Prior treatment with mTOR inhibitors
- Symptomatic congestive heart failure of New York heart Association Class III or IV
- Uncontrolled diabetes as defined by fasting serum glucose >160 mg/dl or 8.9 mmol/l
Show all 13Show fewer
- Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
- Chemotherapy within the last 4 weeks before inclusion; radiotherapy, or any other investigational agent within 14 days or 5 half-lives, whichever is longer prior to the first dose of study drug
- Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
- Impaired cardiac function or clinically significant cardiac diseases, or liver, respiratory or hepatic disease
- Known diagnosis of HIV infection
- Patient with ongoing toxicity Grade ≥ 2 according to the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0
- Pregnant or breast feeding women (a pregnancy test will be performed within 7 days before inclusion).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Institut Bergonié
Bordeaux, Gironde, 33076
Centre Oscar Lambret
Lille, Nord, 59000
CHRU de Lille - Hôpital Roger Salengro
Lille, Nord, 59037
Centre Hospitalier Universitaire de Limoges, Hôpital Dupuytren
Limoges, Haute Vienne, 87042
Centre Léon Bérard
Lyon, Rhône, 69373
Institut Régional du Cancer de Montpellier
Montpellier, Hérault, 34298
Centre Hospitalier Universitaire de Nantes, Hôtel Dieu
Nantes, Loire Atlantique, 44093
Institut de Cancérologie de l'Ouest - René Gauducheau
Saint-Herblain, Loire Atlantique, 44805
Institut Claudius Regaud
Toulouse, Haute Garonne, 31052
Centre Hospitalier Régional Universitaire de Tours, Hôpital Trousseau
Tours, Indre et Loire, 37044
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Meurthe et Moselle, 54511
Institut Gustave Roussy
Villejuif, Val de Marne, 94805
About this study
Official title: A Randomized Prospective, Multicentric, Open Label, Phase II Study Aiming to Evaluate the Efficacity and Safety of EVEROLIMUS as Neo-adjuvant Therapy in Patients With Primary or Relapsed Chondrosarcomas
The mainstay of chondrosarcoma treatment is a wide surgical resection. Unfortunately, this is a rare occurrence, and patients with incomplete resection have very poor therapeutic options. In this context, it becomes important to find new therapeutic strategies to slow down tumor progression and to reduce tumor size before resection.
Pre-clinical and clinical data suggest that EVEROLIMUS should be efficient as adjuvant and neo-adjuvant therapy in chondrosarcoma.
Read more
Then, investigators propose a phase II, randomized, open label study compounded by 3 arms (1:1:1) to assess efficiency of EVEROLIMUS as neo-adjuvant therapy in patients with primary or relapsed chondrosarcomas :
ARM 1 = No treatment; ARM 2 = 2,5 mg Everolimus/day; ARM 3 = 10 mg Everolimus/day.
The treatments will be taken for 4 weeks before surgery, apart from any premature withdrawn
Read the detailed description
Chondrosarcomas (CHS) represent 25% of bone sarcomas and are the second most frequent primary malignant type of bone tumor. No effective systemic treatment has been identified in advanced or adjuvant phases for CHS. As CHS are relatively resistant to chemo- and radiotherapy, surgery remains the primary treatment of this tumor type. The aim of tumor resection is to obtain complete removal of the malignant lesion with adequate margins taking into account tumor control and functional reconstruction. However, considering the particular localizations of CHS, a wide resection (i.e. R0 clear margins) is rarely achieved. Unfortunately, therapeutic options are limited for patients with incomplete resection. In this context, new therapeutic strategies are needed to slow down tumor progression and to reduce tumor size before surgery.
Increasing knowledge of the signal transduction pathways involved in oncogenesis has led to speculation that components of signalling pathways could be envisaged as novel targets for cancer therapy. Mammalian Target of Rapamycin (mTOR), which lies downstream of the Phosphatidylinositol 3-kinase/B kinase protein (PI3K/Akt) pathway, plays a central role in the regulation of cancer cell growth, suggesting that mTOR could be an attractive target for anti-cancer therapy. The PI3K-Akt-mTOR signaling pathway is intimately implicated in sarcoma development and progression. Indeed, mutations and/ or overexpression of one or several components of the PI3K-Akt-mTOR pathway are often observed in sarcoma. These alterations, located both upstream and downstream of mTOR, lead to dysregulation of the mTOR pathway. mTOR inhibitor evaluation as anticancer agents has began with rapamycin analogues (called rapalogs). Currently, mTOR inhibitors under clinical development include temsirolimus (CCI-779, Torisel®, Wyeth Pharmaceuticals), everolimus (RAD001, Afinitor®, Novartis Pharmaceuticals), and ridaforolimus (AP23573, ARIAD Pharmaceuticals). mTOR inhibitors were found to be efficient in various preclinical cancer models, for example in a preclinical mouse model of follicular thyroid cancer, everolimus induced a significant decrease in proliferation of cancer cells.
Two sets of recent data suggest that inhibition of mTOR pathway could be an effective systemic treatment for chondrosarcoma. The first one is a case report describing an impressive tumor response in a patient with myxoid chondrosarcoma treated by rapamycin in combination with cyclophosphamide. The second one concerns nonclinical data generated by our institution. Using an orthotopic rat chondrosarcoma model, we have shown that monotherapy with everolimus inhibits chondrosarcoma proliferation as evaluated by Ki67 expression and significantly reduced tumor volume. Importantly, when given in a "pseudo-adjuvant" setting following R1 resection of the implanted tumor, everolimus significantly delayed tumor recurrence. These preclinical data provide a strong rationale to evaluate the therapeutic potential of everolimus in both the neo-adjuvant and adjuvant settings in patients with chondrosarcoma.
In this context, the proposal of the investigators is to perform a multicenter, randomized, Phase II study in patients with a primary or relapsed chondrosarcoma in neo-adjuvant setting
- Conditions
- Chondrosarcoma
- Being tested
- Everolimus 2.5 mg/day, Everolimus 10 mg/day
- Keywords
- Chondrosarcoma, Neoadjuvant therapy, Phase II, Everolimus, Success Rate, Progression Free Survival, Overall Survival, Safety, Quality of Life, Molecular study (ancillary study)
- Medical subject headings
- Chondrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus 2.5 mg/dayDrug
Also called Afinitor; Votubia; RAD-001
Comparison between 2,5 mg/day of Everolimus per os to 10 mg/day, or to no treatment, taken during 30 days before chondrosarcoma surgery
Everolimus 10 mg/dayDrug
Also called Afinitor; Votubia; RAD-001
Comparison between 10 mg/day of Everolimus per os to 2.5 mg/day, or to no treatment taken during 30 days before chondrosarcoma surgery
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No intervention | No Everolimus treatment before surgery |
| Everolimus 2,5 mg/day | Experimental | Everolimus treatment at 2,5 mg/day for 30 days Receives: Drug: Everolimus 2.5 mg/day |
| Everolimus 10 mg/day | Experimental | Everolimus treatment at 10 mg/day for 30 days Receives: Drug: Everolimus 10 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate obtained per arm
A success is defined as a variation (decrease) of Ki67 expression > 10% during treatment
Measured: 4 weeks after inclusion
Secondary outcomes (4)
Progression-Free Survival (PFS)
PFS = Time from randomization until the date of event defined as the first documented progression or death due to any cause. Patients without any progression at the end of the 3 years follow up will be censured at this date.
Measured: At time of progression in the course of the 3 years follow up after randomization
Safety
Based on the frequency of Adverse Events according to common toxicity criteria (CTC V4.0), taking to account post operative complications and functional outcomes
Measured: In the course of the 3 years after randomization
Overall Survival
Patients who are alive at the end of the 3 years follow up will be censured at this date.
Measured: At time of death if occuring during the 3 years of follow up after randomization
Quality of Life
Data collected from a questionnaire at inclusion, surgery, 3th month, 6th month, 12th month, 24th month and 36th month after surgery
Measured: From randomization to the end of the 3 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study start14 Aug 2014
- Primary completionAug 2018 (estimated)
- Study completionAug 2019 (estimated)
Why it stopped: The study was suspended since july 27th 2016 because of unavailability of Everolimus
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for ChondrosarcomaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Yves Blay, Professor, Principal investigator, Centre Léon Bérard, LyonFrançois Gouin, Professor, Principal investigator, Centre Hospitalier Universitaire de Nantes, Hôtel Dieu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008019
- Sponsor's protocol ID
- CHONRAD
- Acronym
- CHONRAD
- Status last verified
- Aug 2017
- First submitted
- 6 Dec 2013
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lichtenstein L, Jaffe HL. Chondrosarcoma of Bone. Am J Pathol. 1943 Jul;19(4):553-89. No abstract available.
PubMed 19970709Dahlin DC, Unni KK Bone tumors: general aspects and data on 8542 cases. Fourth ed. Sprinfield, Illinois: Charles C Thomas,1986.
Enneking WF. Musculoskeletal tumor surgery. Vol 2. New York, Churchill Livingstone, 1983: 875-997.
O'NEAL LW, ACKERMAN LV. Chondrosarcoma of bone. Cancer. 1952 May;5(3):551-77. doi: 10.1002/1097-0142(195205)5:33.0.co;2-z. No abstract available.
PubMed 14925925Fiorenza F, Abudu A, Grimer RJ, Carter SR, Tillman RM, Ayoub K, Mangham DC, Davies AM. Risk factors for survival and local control in chondrosarcoma of bone. J Bone Joint Surg Br. 2002 Jan;84(1):93-9. doi: 10.1302/0301-620x.84b1.11942.
PubMed 11837841Lee FY, Mankin HJ, Fondren G, Gebhardt MC, Springfield DS, Rosenberg AE, Jennings LC. Chondrosarcoma of bone: an assessment of outcome. J Bone Joint Surg Am. 1999 Mar;81(3):326-38. doi: 10.2106/00004623-199903000-00004.
PubMed 10199270Pritchard DJ, Lunke RJ, Taylor WF, Dahlin DC, Medley BE. Chondrosarcoma: a clinicopathologic and statistical analysis. Cancer. 1980 Jan 1;45(1):149-57. doi: 10.1002/1097-0142(19800101)45:13.0.co;2-a.
PubMed 7350999Gitelis S, Bertoni F, Picci P, Campanacci M. Chondrosarcoma of bone. The experience at the Istituto Ortopedico Rizzoli. J Bone Joint Surg Am. 1981 Oct;63(8):1248-57.
PubMed 7287795Evans HL, Ayala AG, Romsdahl MM. Prognostic factors in chondrosarcoma of bone: a clinicopathologic analysis with emphasis on histologic grading. Cancer. 1977 Aug;40(2):818-31. doi: 10.1002/1097-0142(197708)40:23.0.co;2-b. No abstract available.
PubMed 890662Pring ME, Weber KL, Unni KK, Sim FH. Chondrosarcoma of the pelvis. A review of sixty-four cases. J Bone Joint Surg Am. 2001 Nov;83(11):1630-42.
PubMed 11701784Miser JS, Pappo AS, Triche TJ et al. In: Pizzo PA, Poplack DG, eds. Principles and Practice of Pediatric Oncology. Other soft tissue sarcomas of childhood. Philadelphia, PA: Lippincott Williams & Wilkins, 2002:1017-1050.
Marina N, Gebhardt M, Teot L, Gorlick R. Biology and therapeutic advances for pediatric osteosarcoma. Oncologist. 2004;9(4):422-41. doi: 10.1634/theoncologist.9-4-422.
PubMed 15266096Fingar DC, Blenis J. Target of rapamycin (TOR): an integrator of nutrient and growth factor signals and coordinator of cell growth and cell cycle progression. Oncogene. 2004 Apr 19;23(18):3151-71. doi: 10.1038/sj.onc.1207542.
PubMed 15094765Hay N, Sonenberg N. Upstream and downstream of mTOR. Genes Dev. 2004 Aug 15;18(16):1926-45. doi: 10.1101/gad.1212704.
PubMed 15314020Faivre S, Kroemer G, Raymond E. Current development of mTOR inhibitors as anticancer agents. Nat Rev Drug Discov. 2006 Aug;5(8):671-88. doi: 10.1038/nrd2062.
PubMed 16883305
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective, Multicentric, Open Label, Phase II Study Aiming to Evaluate the Efficacity and Safety of EVEROLIMUS as Neo-adjuvant Therapy in Patients With Primary or Relapsed Chondrosarcomas
- ClinicalTrials.gov ID
- NCT02008019
- Acronym / sponsor ID
- CHONRAD / CHONRAD
- Conditions
- Chondrosarcoma
- Keywords
- Chondrosarcoma, Neoadjuvant therapy, Phase II, Everolimus, Success Rate, Progression Free Survival, Overall Survival, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study was suspended since july 27th 2016 because of unavailability of Everolimus
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 14 Aug 2014 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The mainstay of chondrosarcoma treatment is a wide surgical resection. Unfortunately, this is a rare occurrence, and patients with incomplete resection have very poor therapeutic options. In this context, it becomes important to find new therapeutic strategies to slow down tumor progression and to reduce tumor size before resection.
Pre-clinical and clinical data suggest that EVEROLIMUS should be efficient as adjuvant and neo-adjuvant therapy in chondrosarcoma.
Then, investigators propose a phase II, randomized, open label study compounded by 3 arms (1:1:1) to assess efficiency of EVEROLIMUS as neo-adjuvant therapy in patients with primary or relapsed chondrosarcomas :
ARM 1 = No treatment; ARM 2 = 2,5 mg Everolimus/day; ARM 3 = 10 mg Everolimus/day.
The treatments will be taken for 4 weeks before surgery, apart from any premature withdrawn
Detailed description
Chondrosarcomas (CHS) represent 25% of bone sarcomas and are the second most frequent primary malignant type of bone tumor. No effective systemic treatment has been identified in advanced or adjuvant phases for CHS. As CHS are relatively resistant to chemo- and radiotherapy, surgery remains the primary treatment of this tumor type. The aim of tumor resection is to obtain complete removal of the malignant lesion with adequate margins taking into account tumor control and functional reconstruction. However, considering the particular localizations of CHS, a wide resection (i.e. R0 clear margins) is rarely achieved. Unfortunately, therapeutic options are limited for patients with incomplete resection. In this context, new therapeutic strategies are needed to slow down tumor progression and to reduce tumor size before surgery.
Increasing knowledge of the signal transduction pathways involved in oncogenesis has led to speculation that components of signalling pathways could be envisaged as novel targets for cancer therapy. Mammalian Target of Rapamycin (mTOR), which lies downstream of the Phosphatidylinositol 3-kinase/B kinase protein (PI3K/Akt) pathway, plays a central role in the regulation of cancer cell growth, suggesting that mTOR could be an attractive target for anti-cancer therapy. The PI3K-Akt-mTOR signaling pathway is intimately implicated in sarcoma development and progression. Indeed, mutations and/ or overexpression of one or several components of the PI3K-Akt-mTOR pathway are often observed in sarcoma. These alterations, located both upstream and downstream of mTOR, lead to dysregulation of the mTOR pathway. mTOR inhibitor evaluation as anticancer agents has began with rapamycin analogues (called rapalogs). Currently, mTOR inhibitors under clinical development include temsirolimus (CCI-779, Torisel®, Wyeth Pharmaceuticals), everolimus (RAD001, Afinitor®, Novartis Pharmaceuticals), and ridaforolimus (AP23573, ARIAD Pharmaceuticals). mTOR inhibitors were found to be efficient in various preclinical cancer models, for example in a preclinical mouse model of follicular thyroid cancer, everolimus induced a significant decrease in proliferation of cancer cells.
Two sets of recent data suggest that inhibition of mTOR pathway could be an effective systemic treatment for chondrosarcoma. The first one is a case report describing an impressive tumor response in a patient with myxoid chondrosarcoma treated by rapamycin in combination with cyclophosphamide. The second one concerns nonclinical data generated by our institution. Using an orthotopic rat chondrosarcoma model, we have shown that monotherapy with everolimus inhibits chondrosarcoma proliferation as evaluated by Ki67 expression and significantly reduced tumor volume. Importantly, when given in a "pseudo-adjuvant" setting following R1 resection of the implanted tumor, everolimus significantly delayed tumor recurrence. These preclinical data provide a strong rationale to evaluate the therapeutic potential of everolimus in both the neo-adjuvant and adjuvant settings in patients with chondrosarcoma.
In this context, the proposal of the investigators is to perform a multicenter, randomized, Phase II study in patients with a primary or relapsed chondrosarcoma in neo-adjuvant setting
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No treatment | No intervention | –No Everolimus treatment before surgery |
| Everolimus 2,5 mg/day | Experimental | Drug: Everolimus 2.5 mg/dayEverolimus treatment at 2,5 mg/day for 30 days |
| Everolimus 10 mg/day | Experimental | Drug: Everolimus 10 mg/dayEverolimus treatment at 10 mg/day for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or Female ≥ 18 years
- Histopathologically confirmed diagnosis of primary or relapsed conventional CHS of the bone (with or without metastases), CHS of any size on MRI if relapse OR size ≥ 10 cm on MRI at diagnosis OR CHS < 10 cm if R0 resection with adequate margins is not feasible at 1st examination (localization, tumor infiltration within surrounding tissues).
- Patient with life expectancy > 6 months
- Planned surgery between D32- D40 after inclusion
- Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2
Key exclusion criteria (13 listed)
- Mesenchymal, dedifferentiated, clear cell subtype chondrosarcoma, and soft tissues chondrosarcoma
- Tumor tissue sample not available for pathological review/or correlative studies
- Patients may not be receiving any other investigational agents
- Prior treatment with mTOR inhibitors
- Symptomatic congestive heart failure of New York heart Association Class III or IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everolimus 2.5 mg/dayAlso: Afinitor; Votubia; RAD-001Comparison between 2,5 mg/day of Everolimus per os to 10 mg/day, or to no treatment, taken during 30 days before chondrosarcoma surgery | Drug | Everolimus 2,5 mg/day |
| Everolimus 10 mg/dayAlso: Afinitor; Votubia; RAD-001Comparison between 10 mg/day of Everolimus per os to 2.5 mg/day, or to no treatment taken during 30 days before chondrosarcoma surgery | Drug | Everolimus 10 mg/day |
Primary outcome
Success Rate obtained per arm
Time frame: 4 weeks after inclusion
A success is defined as a variation (decrease) of Ki67 expression > 10% during treatment
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: At time of progression in the course of the 3 years follow up after randomization
Safety
Time frame: In the course of the 3 years after randomization
Overall Survival
Time frame: At time of death if occuring during the 3 years of follow up after randomization
Quality of Life
Time frame: From randomization to the end of the 3 years follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Background: PubMed 19970709Lichtenstein L, Jaffe HL. Chondrosarcoma of Bone. Am J Pathol. 1943 Jul;19(4):553-89. No abstract available.
- BackgroundDahlin DC, Unni KK Bone tumors: general aspects and data on 8542 cases. Fourth ed. Sprinfield, Illinois: Charles C Thomas,1986.
- BackgroundEnneking WF. Musculoskeletal tumor surgery. Vol 2. New York, Churchill Livingstone, 1983: 875-997.
- Background: PubMed 14925925O'NEAL LW, ACKERMAN LV. Chondrosarcoma of bone. Cancer. 1952 May;5(3):551-77. doi: 10.1002/1097-0142(195205)5:33.0.co;2-z. No abstract available.
- Background: PubMed 11837841Fiorenza F, Abudu A, Grimer RJ, Carter SR, Tillman RM, Ayoub K, Mangham DC, Davies AM. Risk factors for survival and local control in chondrosarcoma of bone. J Bone Joint Surg Br. 2002 Jan;84(1):93-9. doi: 10.1302/0301-620x.84b1.11942.
- Background: PubMed 10199270Lee FY, Mankin HJ, Fondren G, Gebhardt MC, Springfield DS, Rosenberg AE, Jennings LC. Chondrosarcoma of bone: an assessment of outcome. J Bone Joint Surg Am. 1999 Mar;81(3):326-38. doi: 10.2106/00004623-199903000-00004.
- Background: PubMed 7350999Pritchard DJ, Lunke RJ, Taylor WF, Dahlin DC, Medley BE. Chondrosarcoma: a clinicopathologic and statistical analysis. Cancer. 1980 Jan 1;45(1):149-57. doi: 10.1002/1097-0142(19800101)45:13.0.co;2-a.
- Background: PubMed 7287795Gitelis S, Bertoni F, Picci P, Campanacci M. Chondrosarcoma of bone. The experience at the Istituto Ortopedico Rizzoli. J Bone Joint Surg Am. 1981 Oct;63(8):1248-57.
- Background: PubMed 890662Evans HL, Ayala AG, Romsdahl MM. Prognostic factors in chondrosarcoma of bone: a clinicopathologic analysis with emphasis on histologic grading. Cancer. 1977 Aug;40(2):818-31. doi: 10.1002/1097-0142(197708)40:23.0.co;2-b. No abstract available.
- Background: PubMed 11701784Pring ME, Weber KL, Unni KK, Sim FH. Chondrosarcoma of the pelvis. A review of sixty-four cases. J Bone Joint Surg Am. 2001 Nov;83(11):1630-42.
- BackgroundMiser JS, Pappo AS, Triche TJ et al. In: Pizzo PA, Poplack DG, eds. Principles and Practice of Pediatric Oncology. Other soft tissue sarcomas of childhood. Philadelphia, PA: Lippincott Williams & Wilkins, 2002:1017-1050.
- Background: PubMed 15266096Marina N, Gebhardt M, Teot L, Gorlick R. Biology and therapeutic advances for pediatric osteosarcoma. Oncologist. 2004;9(4):422-41. doi: 10.1634/theoncologist.9-4-422.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Yves Blay, Professor principal investigator
Centre Léon Bérard, Lyon
François Gouin, Professor principal investigator
Centre Hospitalier Universitaire de Nantes, Hôtel Dieu
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Everolimus 2.5 mg/day and Everolimus 10 mg/day in people with Chondrosarcoma, run by Centre Leon Berard at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate obtained per arm (time frame: 4 weeks after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02008019, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.