Osteosarcoma of PelvisNCT03360760
Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum
A study testing Doxorubicin, Cisplatin and Methotrexate in people with Osteosarcoma of Pelvis, run by Peking University People's Hospital at 1 site in China.
Trial summary
To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Osteosarcoma of Pelvis
- What is being tested?
- Doxorubicin, Cisplatin and Methotrexate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to Feb 2025
- Phase
- Interventional
- 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 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100034
Jie Xu, M.D., 86 15901040835, xujie_pkuph@sina.com
About this study
Official title: Presurgical Chemotherapy Compared With Immediate Surgery and Adjuvant Chemotherapy for Nonmetastatic Osteosarcoma of the Pelvis and Sacrum
To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum.
Read the detailed description
Successful therapeutic interventions to prevent disease progression in patients with nonmetastatic osteosarcoma of pelvis and sacrum have included surgery with adjuvant chemotherapy. Pre-surgical chemotherapy has been advocated for these patients because of putative improvement in event-free survival (EFS). The advantages of pre-surgical chemotherapy include early administration of systemic chemotherapy, shrinkage of primary tumor, and pathologic identification of risk groups. The theoretic disadvantage is that it exposes a large tumor burden to marginally effective chemotherapy, especially in the axial region. The contribution of chemotherapy and surgery timing has not been tested rigorously. To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum, we conducted multicenter randomized trial to determine whether chemotherapy administered before definitive resection of primary tumors improved EFS and overall survival compared with traditional resection of the primary tumor followed by adjuvant chemotherapy.
- Conditions
- Osteosarcoma of Pelvis
- Being tested
- Doxorubicin, Cisplatin, Methotrexate, Ifosfamide, definitive surgery
- Keywords
- osteosarcoma, pelvis, sacrum
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Also called Adriamycin
60mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
CisplatinDrug
Also called cisplatinum, platamin
100mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
MethotrexateDrug
Also called HD-MTX
High dose of methotrexate (8-12g/m^2), in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
IfosfamideDrug
Also called ifosphamide
12g/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
definitive surgeryProcedure or surgery
Including limb-sparing procedure and amputation
pre surgical chemotherapyOther
Also called neoadjuvant chemotherapy
chemotherapy that given before definitive surgery
| Study group | Role | What they receive |
|---|---|---|
| Pre surgical Chemotherapy | Experimental | 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). Receives: Drug: Doxorubicin; Drug: Cisplatin; Drug: Methotrexate; Drug: Ifosfamide; Procedure: definitive surgery; Other: pre surgical chemotherapy |
| Immediate Surgery | Other | Immediate definitive surgery, and then post operative chemotherapy based on doxorubicin, cisplatin, high-dose MTX and ifosfamide according to chemotherapy regimen in PKUPH. Receives: Drug: Doxorubicin; Drug: Cisplatin; Drug: Methotrexate; Drug: Ifosfamide; Procedure: definitive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Calculated from the date of treatment start until death, whichever comes first.
Measured: 5 years
Secondary outcomes (2)
Progression-free survival (PFS)
Calculated from the date of treatment start until the time of disease progression or death, whichever comes first.
Measured: 5 years
Tumor necrosis rate
The percentage of tumor necrosis calculated in the resected specimen in Arm 2.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Aug 2018
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteosarcoma of PelvisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUO WEI, Peking University People's Hospital
- Investigators
- Wei Guo, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360760
- Sponsor's protocol ID
- PKUPH-sarcoma 04
- Status last verified
- Aug 2018
- First submitted
- 26 Nov 2017
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presurgical Chemotherapy Compared With Immediate Surgery and Adjuvant Chemotherapy for Nonmetastatic Osteosarcoma of the Pelvis and Sacrum
- ClinicalTrials.gov ID
- NCT03360760
- Acronym / sponsor ID
- PKUPH-sarcoma 04
- Conditions
- Osteosarcoma of Pelvis
- Keywords
- osteosarcoma, pelvis, sacrum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 4 Dec 2017 (actual)
- 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.
To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum.
Detailed description
Successful therapeutic interventions to prevent disease progression in patients with nonmetastatic osteosarcoma of pelvis and sacrum have included surgery with adjuvant chemotherapy. Pre-surgical chemotherapy has been advocated for these patients because of putative improvement in event-free survival (EFS). The advantages of pre-surgical chemotherapy include early administration of systemic chemotherapy, shrinkage of primary tumor, and pathologic identification of risk groups. The theoretic disadvantage is that it exposes a large tumor burden to marginally effective chemotherapy, especially in the axial region. The contribution of chemotherapy and surgery timing has not been tested rigorously. To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum, we conducted multicenter randomized trial to determine whether chemotherapy administered before definitive resection of primary tumors improved EFS and overall survival compared with traditional resection of the primary tumor followed by adjuvant chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre surgical Chemotherapy | Experimental | Drug: Doxorubicin, Drug: Cisplatin, Drug: Methotrexate, Drug: Ifosfamide, Procedure: definitive surgery, Other: pre surgical chemotherapyImmediate 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). |
| Immediate Surgery | Other | Drug: Doxorubicin, Drug: Cisplatin, Drug: Methotrexate, Drug: Ifosfamide, Procedure: definitive surgeryImmediate definitive surgery, and then post operative chemotherapy based on doxorubicin, cisplatin, high-dose MTX and ifosfamide according to chemotherapy regimen in PKUPH. |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| DoxorubicinAlso: Adriamycin60mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH | Drug | Immediate Surgery, Pre surgical Chemotherapy |
| CisplatinAlso: cisplatinum, platamin100mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH | Drug | Immediate Surgery, Pre surgical Chemotherapy |
| MethotrexateAlso: HD-MTXHigh dose of methotrexate (8-12g/m^2), in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH | Drug | Immediate Surgery, Pre surgical Chemotherapy |
| IfosfamideAlso: ifosphamide12g/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH | Drug | Immediate Surgery, Pre surgical Chemotherapy |
| definitive surgeryIncluding limb-sparing procedure and amputation | Procedure or surgery | Immediate Surgery, Pre surgical Chemotherapy |
| pre surgical chemotherapyAlso: neoadjuvant chemotherapychemotherapy that given before definitive surgery | Other | Pre surgical Chemotherapy |
Primary outcome
Overall survival (OS)
Time frame: 5 years
Calculated from the date of treatment start until death, whichever comes first.
2 secondary outcomes
Progression-free survival (PFS)
Time frame: 5 years
Tumor necrosis rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Individual participant dataSharing planned: Undecided. Undecided
Related trials for Osteosarcoma of Pelvis
RecruitingObservational study
Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for Management of Pelvic Sarcomas Involving the Bone
Bone Sarcoma, Chondrosarcoma
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.
Wei Guo principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxorubicin, Cisplatin and Methotrexate in people with Osteosarcoma of Pelvis, run by Peking University People's Hospital at 1 site in China.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
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?
Contact Jie Xu, M.D. (86 15901040835, xujie_pkuph@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2018.