Clinical trial · Interventional
Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum
Presurgical Chemotherapy Compared With Immediate Surgery and Adjuvant Chemotherapy for Nonmetastatic Osteosarcoma of the Pelvis and Sacrum
NCT03360760CI-TRIAL-00034613unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma of Pelvis | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| definitive surgery | Procedure | — | UNRESOLVED |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| pre surgical chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pre surgical Chemotherapy
- description
- Immediate pre surgical chemotherapy treated with four drugs including doxorubicin, cisplatin, high-dose methotrexate (MTX) and ifosfamide in eleven weeks, and then definitive surgery followed by adjuvant chemotherapy according to chemotherapy regimen in Peking University People's Hospital(PKUPH).
- interventionNames
- Drug: Doxorubicin
- Drug: Cisplatin
- Drug: Methotrexate
- Drug: Ifosfamide
- Procedure: definitive surgery
- Other: pre surgical chemotherapy
- type
- OTHER
- label
- Immediate Surgery
- description
- Immediate definitive surgery, and then post operative chemotherapy based on doxorubicin, cisplatin, high-dose MTX and ifosfamide according to chemotherapy regimen in PKUPH.
- interventionNames
- Drug: Doxorubicin
- Drug: Cisplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>10 years and \<40 years; * High-grade nonmetastatic osteosarcoma in pelvis or sacrum; * Diagnosis confirmed histologically and reviewed centrally; * No evidence of metastatic disease with computed tomography scan of the chest and radionuclide bone scan, or Positron Emission Tomography (PET/CT) within 2 weeks of entry; * No prior therapy; * Eastern Cooperative Oncology Group performance status 0-1; * Life expectancy \>3 months; * Adequate renal, hepatic, and hemopoietic function; Exclusion Criteria: * Previously treated by chemotherapy or unplanned surgery in other hospital; * Have had other kinds of malignant tumors at the same time; * Uncontrolled complications, such as diabetes mellitus and so on; * Intravascular tumor thrombus on enhanced CT or magnetic resonance (MR); * Unresectable disease evaluated by surgeons.
References
Publications (0)
Data not yet available
No reference posted for this study.