Osteosarcoma Clinical Trial
— PROACHOfficial title:
A Phase II Study of Gemcitabine-docetaxel Chemotherapy With Anti-angiogenic Therapy for Pulmonary Resectable Metastases of Osteosarcoma
Verified date | October 2023 |
Source | Ruijin Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the efficacy and safety of Second-line chemotherapy combined with Apatinib for the patients with resectable pulmonary metastasis of osteosarcoma.
Status | Active, not recruiting |
Enrollment | 43 |
Est. completion date | December 30, 2023 |
Est. primary completion date | November 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 50 Years |
Eligibility | Inclusion Criteria: - age between 10 and 50 years; - diagnosis of histologically confirmed high grade osteosarcoma; - identification of pulmonary metastases without the existence of local recurrence(previous re-resection of local recurrence with wide margin is allowed). - resectable pulmonary nodule(s), defined as nodule(s) that are removable by wedge resection/ segmentectomy/lobectomy without necessitating a pneumonectomy (e.g., nodules immediately adjacent to the main stem bronchus or main pulmonary vessels) - prior treatment consisted of standard National Comprehensive Cancer Network (NCCN) guideline recommended first-line chemotherapy - wide/radical-margin surgical resection of the primary tumor completed at least 4 weeks before enrollment. - Eastern Cooperative Oncology Group(ECOG) performance status 0-2 with a life expectancy >3 months; - adequate renal, hepatic, and hemopoietic function; - normal or controlled blood pressure; - no thoracic comorbidities with adequate pulmonary function eligible for thoracic surgery Exclusion Criteria: - previously exposed to GD chemotherapy or VEGFR2 Tyrosine-kinase inhibitors (TKIs); - existence of local recurrence; - have had other kinds of malignant tumors at the same time; - cardiac insufficiency or arrhythmia; - uncontrolled complications, such as diabetes mellitus and so on; - coagulation disorders or Hemorrhagic diseases ; - metastases considered unresectable or borderline resectable at baseline - intolerable of thoracis surgery - pleural or peritoneal effusion that needs to be handled by surgical treatment; - combined with other infections or wounds - wound dystrophy, poor soft-tissue around implantation or other wound complications risky of non-healing given angiogenesis inhibitor assessed by the investigators |
Country | Name | City | State |
---|---|---|---|
China | Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory outcome: Subgroup analysis of progression-free survival(PFS) | The PFS for each subgroups in terms of clinicopathological characteristics (age, gender, histological type, solitary or multiple metastases, unilateral or bilateral metastases, early or late metastases, calcifying or non-calcifying lesions, with or without lesion cavitation, with or without AEs [especially pneumothorax, hand-foot skin reactions, hair depigmentation], etc) | Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years) | |
Other | Exploratory outcome: The correlation of potential pathological biomarker with PFS | The correlation between the expression of VEGFR2, CD34, Ki-67 and immune cell infiltration by immunohistochemistry and PFS | Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years) | |
Other | Exploratory outcome: Tumor response pre-metastasectomy as a predictor of PFS | to compare the PFS of the three group according to tumor response pre-metastasectomy (group1: CR/PR, group2: SD, group3 PD) | Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years) | |
Other | Exploratory outcome: Tumor cavitation as a prognostic factor for oncological outcome | to compare the predictive value of the Crabb's modified RECIST criteria with the original RECIST 1.1 criteria in terms of PFS and OS | Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years) | |
Other | Exploratory outcome: AEs of the targeted therapy as prognostic factors for oncological outcome, especially pulmonary lesion cavitation/pneumothorax and hair depigmentation | to correlate the incidence of targeted therapy related AEs (especially pneumothorax, hand foot skin reactions, skin and hair depigmentation and fatigue)with the PFS/OS for the treatment arm. | Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years) | |
Other | Correlation of KDR 604 polymorphism with pulmonary lesion cavitation/pneumothorax and with PFS | According to our previous retrospective analysis, we aim the validate the correlation of KDR 604 AA,AG,GG genotype with the incidence of pulmonary lesion cavitation/pneumothorax and PFS among all patients. | Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years) | |
Other | Exploratory outcome: 1.0-mm CT scan for the early identification small lung nodule as pulmonary recurrence | to compare the diagnostic value of the 1.0 mm versus 5.0 mm CT scan for the radiological evaluation of small lung nodule as tumor recurrence | Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years) | |
Primary | 12 months Progression-free survival rate(12mPFR) | The proportion of patients with progression-free survival at 12 months according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). A 12mPFR of 30% or less is considered inactive, while a 12mPFR of 50% or greater is regarded as of interest for additional development | 12 months from the recruitment of the study | |
Secondary | Overall survival (OS) | calculated from the date of treatment start until last follow-up or death, whichever comes first. | Baseline until death, followed through study completion, an average of 2 years | |
Secondary | Total resectability | The number of patients undergoing pre-planned metastasectomy divided by the number of patients considered resectable at baseline | after neoadjuvant systemic therapy, an average of 8~9 weeks | |
Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The occurrence of each adverse events(AEs), severe AEs(SAEs) and death according the CTCAE_5.0 | through study completion, an average of 1 years | |
Secondary | Objective response rate (ORR) | Complete Response(CR)+Partial Response(PR) after neoadjuvant systemic therapy | after neoadjuvant systemic therapy, an average of 8~9 weeks | |
Secondary | Clinical benefit rate (CBR) | CR+PR+stable disease (SD) after neoadjuvant systemic therapy | after neoadjuvant systemic therapy, an average of 8~9 weeks | |
Secondary | Progression free survival (PFS) | Progression free survival according to RECIST 1.1 | Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years) | |
Secondary | OS rate | the proportion of OS at 12, 24 months | 12 and 24 months from baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00026780 -
Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
|
||
Not yet recruiting |
NCT05515068 -
Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
|
||
Completed |
NCT02383901 -
A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX
|
N/A | |
Active, not recruiting |
NCT01758666 -
A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy
|
N/A | |
Completed |
NCT01674101 -
Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy
|
N/A | |
Completed |
NCT01615640 -
Diffusion Study on Patients With Osteosarcoma
|
||
Completed |
NCT00523419 -
Chemotherapy for Patients With Osteosarcoma
|
Phase 2 | |
Completed |
NCT00520936 -
A Study of Pemetrexed in Children With Recurrent Cancer
|
Phase 2 | |
Completed |
NCT00132158 -
ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors
|
Phase 1 | |
Not yet recruiting |
NCT04319874 -
Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma
|
Phase 2 | |
Recruiting |
NCT06029218 -
Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy
|
N/A | |
Recruiting |
NCT05642455 -
SPEARHEAD-3 Pediatric Study
|
Phase 1/Phase 2 | |
Recruiting |
NCT06117878 -
Safety and Efficacy of NK510 to Treat Osteosarcoma and Soft Tissue Sarcoma
|
Early Phase 1 | |
Not yet recruiting |
NCT04316091 -
A Phase I Clinical Trial of Neoadjuvant Chemotherapy With/Without SPIONs/SMF for Patients With Osteosarcoma
|
Phase 1 | |
Recruiting |
NCT03932058 -
Proteomics Research of Osteosarcoma
|
||
Withdrawn |
NCT01236586 -
RO4929097 in Children With Relapsed/Refractory Solid or CNS Tumors, Lymphoma, or T-Cell Leukemia
|
Phase 1 | |
Completed |
NCT00743496 -
A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma
|
Phase 1 | |
Recruiting |
NCT04040205 -
Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration
|
Phase 2 | |
Recruiting |
NCT05970497 -
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT03628209 -
Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma
|
Phase 1/Phase 2 |