Pulmonary Resectable Metastases of Osteosarcoma With Anti-angiogenics and CHemotherapy

Browse trials for

• Neoplasm Metastasis 3,517
• Osteosarcoma 437

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 43 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Study arms

• Experimental
  Apatinib + GD group

  Apatinib + GD regimen. For unilateral metastases,3 cycles before metastasectomy, and 4 cycles after. For bilateral metastases, 3 cycles before first metastasectomy, 1 cycle inbetween, and then second metastasectomy followed by 4 cycles. Apatinib monotherapy is then maintained until 1 year following complete resection.

  Drug: Apatinib · Drug: GD regimen

Interventions

• DrugApatinib

  Apatinib 250mg tablet by mouth, bid. 48 hrs break before and 96 hrs after the surgical resection of the pulmonary metastases.

  Also known as: VEGFR Inhibitor

• DrugGD regimen

  One cycle: gemcitabine 900 mg/m\^2 over 90 min on Day 1, and gemcitabine 900 mg/m\^2 and docetaxel 75 mg/m\^2 on Day 8. Every 21 days were eligible. 1\~2 -week break before and 2-week break after the surgical resection of the pulmonary metastases is taken.

  Also known as: Chemotherapy

Primary outcomes

1. 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

   Time frame: 12 months from the recruitment of the study

Secondary outcomes

1. Overall survival (OS)

   calculated from the date of treatment start until last follow-up or death, whichever comes first.

   Time frame: Baseline until death, followed through study completion, an average of 2 years

2. Total resectability

   The number of patients undergoing pre-planned metastasectomy divided by the number of patients considered resectable at baseline

   Time frame: after neoadjuvant systemic therapy, an average of 8~9 weeks

3. 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

   Time frame: through study completion, an average of 1 years

4. Objective response rate (ORR)

   Complete Response(CR)+Partial Response(PR) after neoadjuvant systemic therapy

   Time frame: after neoadjuvant systemic therapy, an average of 8~9 weeks

5. Clinical benefit rate (CBR)

   CR+PR+stable disease (SD) after neoadjuvant systemic therapy

   Time frame: after neoadjuvant systemic therapy, an average of 8~9 weeks

6. Progression free survival (PFS)

   Progression free survival according to RECIST 1.1

   Time frame: Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years)

7. OS rate

   the proportion of OS at 12, 24 months

   Time frame: 12 and 24 months from baseline

Other outcomes

1. 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)

   Time frame: Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years)

2. 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

   Time frame: Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years)

3. 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)

   Time frame: Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years)

4. 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

   Time frame: Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years)

5. 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.

   Time frame: Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years)

6. 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.

   Time frame: Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years)

7. 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

   Time frame: Baseline until disease progression or death, whichever occurs first (followed through study completion, an average of 1.5 years)

Individual participant data

Plan to share: No — The data of IPD is available to researcher's upon reasonable request, in accordance to the local legislator's policy ( such as genetic sequencing data)