OsteosarcomaPhase 2NCT01002092
A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
A Phase 2 study testing Chemotherapy and Endostar in people with Osteosarcoma, run by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd at 4 sites in China.
Trial summary
Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Chemotherapy and Endostar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesChina
- Study dates
- Feb 2009to Dec 2014
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with histologically confirmed osteosarcoma, who have no evidence of metastasis
- At least one measurable lesion
- Life expectancy > 3 months
- ECOG performance status 0-2
- Adequate hematologic, cardiac, renal, and hepatic function
- Patients with prior chemotherapy should have at least 4 weeks clearance period before entering this study
Who cannot join
- Evidence of metastasis
- Serious infection
- Evidence of bleeding diathesis
- Significant cardiovascular disease
- Pregnant or lactating woman
- Allergic to E.coli preparation
Trial locations and contacts
4 sites in 1 country.
China4 sites
The Military General Hospital of Beijing PLA
Beijing, 100700
General Hospital of Jinan Military Command
Jinan, Shandong, 250031
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu, 210002
Xijing Hospital
Xi’an, Shanxi, 710032
About this study
Official title: A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.
- Conditions
- Osteosarcoma
- Being tested
- Chemotherapy, Endostar
- Keywords
- Osteosarcoma, Endostar, Chemotherapy
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Week 1 day 1 MTX 8 g/m2; Week 3 day 1-2 CDP 100-120 mg/m2 day 1 ADM/THP 60 mg/m2; Week 5 day 1-6 IFO 2 g/day; Week 7 rest; Week 8 surgery; Two weeks after the surgery repeat the chemotherapy cycle 3 times (6 weeks per cycle).
EndostarDrug
In each cycle, Week 1-2 day 1-14 endostar 7.5 mg/m2/day; Week 5-6 day 1-14 endostar 7.5 mg/m2/day
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Active comparator | Not described Receives: Drug: Chemotherapy |
| Endostar plus Chemotherapy | Experimental | Not described Receives: Drug: Chemotherapy; Drug: Endostar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 5 years
Secondary outcomes (5)
Limb Salvage Rate
Measured: end of the first cycle
Overall Survival
Measured: 5 years
Clinical Response Rate
Measured: end of the first cycle
Clinical Benefit Response
Measured: end of the first cycle
Quality of Life
Measured: after 4 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sujia Wu, Dr., Principal investigator, Nanjing PLA General HospitalXin Shi, Dr., Principal investigator, Nanjing PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002092
- Sponsor's protocol ID
- SIM-65
- Status last verified
- Aug 2014
- First submitted
- 25 Oct 2009
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
- ClinicalTrials.gov ID
- NCT01002092
- Acronym / sponsor ID
- SIM-65
- Conditions
- Osteosarcoma
- Keywords
- Osteosarcoma, Endostar, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shandong Simcere-Medgenn Bio-pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 27 Oct 2009 (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.
Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Active comparator | Drug: Chemotherapy |
| Endostar plus Chemotherapy | Experimental | Drug: Chemotherapy, Drug: Endostar |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients with histologically confirmed osteosarcoma, who have no evidence of metastasis
- At least one measurable lesion
- Life expectancy > 3 months
- ECOG performance status 0-2
- Adequate hematologic, cardiac, renal, and hepatic function
Key exclusion criteria (6 listed)
- Evidence of metastasis
- Serious infection
- Evidence of bleeding diathesis
- Significant cardiovascular disease
- Pregnant or lactating woman
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 |
|---|---|---|
| ChemotherapyWeek 1 day 1 MTX 8 g/m2; Week 3 day 1-2 CDP 100-120 mg/m2 day 1 ADM/THP 60 mg/m2; Week 5 day 1-6 IFO 2 g/day; Week 7 rest; Week 8 surgery; Two weeks after the surgery repeat the chemotherapy cycle 3 times (6 weeks per cycle). | Drug | Chemotherapy, Endostar plus Chemotherapy |
| EndostarIn each cycle, Week 1-2 day 1-14 endostar 7.5 mg/m2/day; Week 5-6 day 1-14 endostar 7.5 mg/m2/day | Drug | Endostar plus Chemotherapy |
Primary outcome
Progression Free Survival
Time frame: 5 years
5 secondary outcomes
Limb Salvage Rate
Time frame: end of the first cycle
Overall Survival
Time frame: 5 years
Clinical Response Rate
Time frame: end of the first cycle
Clinical Benefit Response
Time frame: end of the first cycle
Quality of Life
Time frame: after 4 cycles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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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.
Sujia Wu, Dr. principal investigator
Nanjing PLA General Hospital
Xin Shi, Dr. principal investigator
Nanjing PLA General Hospital
4 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 Chemotherapy and Endostar in people with Osteosarcoma, run by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd at 4 sites 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 6 inclusion and 6 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 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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?
Progression Free Survival (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 3 Sep 2014.