Ewing's SarcomaPhase 2NCT00568464
Study on VCD/IE in the Patients With Ewing's Sarcoma Family of Tumors (ESFT)
A Phase 2 study testing VCR, CTX, ADM; IFO, VP-16 in people with Ewing's Sarcoma, run by Fudan University at 1 site in China.
Trial summary
The purpose of this clinical trial was to evaluate the efficacy and tolerability of the sequential therapy of VCD/IE in the patients with ESFT. Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Ewing's Sarcoma
- What is being tested?
- VCR, CTX, ADM; IFO, VP-16
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Mar 2007to Sep 2009
- 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 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age range 10-65 years old
- Histological confirmed ESFT
- No previous therapy
- ECOG performance status less than 2
- Life expectancy of more than 12 weeks
- Normal laboratory values: hemoglobin>8.0g/dl, neutrophil>2×109/L, platelet > 80×109/L, Hb > 80×1012/L, serum creatine < 1×upper limitation of normal(ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN
Who cannot join
- Pregnant or lactating women
- Received treatment for the disease previously
- Serious uncontrolled diseases and intercurrent infection
- The evidence of CNS metastasis and bone marrow involvement
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- History of allergy to the drugs in this trial
- Abnormal LVEF level
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Phase II Study of VCD/IE in the Treatment of the Patients With Ewing's Sarcoma Family of Tumors
The purpose of this clinical trial was to evaluate the efficacy and tolerability of the sequential therapy of VCD/IE in the patients with ESFT.
Read the detailed description
80-90% patients of ESFT will develope disease progression during the period of local treatment (surgery or radiation). The survival has been improved in these 30 years due to chemotherapy. VCD/IE is widely used in the world for the patients with ESFT, but it is rarely used in China due to its high dosage.
- Conditions
- Ewing's Sarcoma
- Being tested
- VCR, CTX, ADM; IFO, VP-16
- Keywords
- ESFT (Ewing's sarcoma family of tumors), Response rate, TTP, OS, Toxicity
- Medical subject headings
- Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCR, CTX, ADM; IFO, VP-16Drug
Also called VCD/IE
VCD: VCR 2 mg d1, CTX 1200 mg/m2 d1, Mesna 240 mg/m2 tid d1, ADM 75mg/m2 d1, G-CSF 300 ug/d d5-11; IE: IFO 1800mg/m2 d1-5,Mesna 360 mg/m2 tid d1-5,VP-16 100 mg/m2 d1-5,G-CSF 300 ug/d d6-12; q3w. Surgery or radiation will be done to the patients with local diseases after four cycles of VCD/IE.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: VCR, CTX, ADM; IFO, VP-16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: every two cycles
Secondary outcomes (1)
Toxicity
Measured: every cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startMar 2007
- Primary completionMay 2009
- Study completionSep 2009 (estimated)
Why it stopped: The enrollment is slower than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ewing's SarcomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Ye Guo, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568464
- Sponsor's protocol ID
- VCD/IE-ESFT
- Status last verified
- Jul 2009
- First submitted
- 5 Dec 2007
- Last updated
- 7 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of VCD/IE in the Treatment of the Patients With Ewing's Sarcoma Family of Tumors
- ClinicalTrials.gov ID
- NCT00568464
- Acronym / sponsor ID
- VCD/IE-ESFT
- Conditions
- Ewing's Sarcoma
- Keywords
- ESFT (Ewing's sarcoma family of tumors), Response rate, TTP, OS, Toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The enrollment is slower than expected
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Sep 2009 (estimated)
- First posted
- 6 Dec 2007 (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.
The purpose of this clinical trial was to evaluate the efficacy and tolerability of the sequential therapy of VCD/IE in the patients with ESFT.
Detailed description
80-90% patients of ESFT will develope disease progression during the period of local treatment (surgery or radiation). The survival has been improved in these 30 years due to chemotherapy. VCD/IE is widely used in the world for the patients with ESFT, but it is rarely used in China due to its high dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: VCR, CTX, ADM; IFO, VP-16 |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age range 10-65 years old
- Histological confirmed ESFT
- No previous therapy
- ECOG performance status less than 2
- Life expectancy of more than 12 weeks
Key exclusion criteria (7 listed)
- Pregnant or lactating women
- Received treatment for the disease previously
- Serious uncontrolled diseases and intercurrent infection
- The evidence of CNS metastasis and bone marrow involvement
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
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 |
|---|---|---|
| VCR, CTX, ADM; IFO, VP-16Also: VCD/IEVCD: VCR 2 mg d1, CTX 1200 mg/m2 d1, Mesna 240 mg/m2 tid d1, ADM 75mg/m2 d1, G-CSF 300 ug/d d5-11; IE: IFO 1800mg/m2 d1-5,Mesna 360 mg/m2 tid d1-5,VP-16 100 mg/m2 d1-5,G-CSF 300 ug/d d6-12; q3w. Surgery or radiation will be done to the patients with local diseases after four cycles of VCD/IE. | Drug | A |
Primary outcome
Response Rate
Time frame: every two cycles
1 secondary outcome
Toxicity
Time frame: every cycle
Results and safety
The study was stopped early (reason given: The enrollment is slower than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2009.
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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.
Ye Guo, M.D. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VCR, CTX, ADM; IFO, VP-16 in people with Ewing's Sarcoma, run by Fudan University 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 7 Jul 2009. 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.
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?
The study was stopped early (reason given: The enrollment is slower than expected). 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?
Response Rate (time frame: every two cycles). 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 7 Jul 2009.