AstrocytomasPhase 3NCT00897377
Treatment Strategy for Low-grade Gliomas
A Phase 3 study testing Radiation therapy and Temozolomide in people with Astrocytomas and Oligodendrogliomas, run by Sun Yat-sen University at 1 site in China.
Trial summary
Although the prognosis of patients with low-grade glioma (LGG) is generally good, recurrence seems unavoidable in some patients because of the infiltrative growth of the tumors. How to treat LGGs is still under controversy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Astrocytomas, Oligodendrogliomas, Oligoastrocytoma
- What is being tested?
- Radiation therapy and Temozolomide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Dec 2007to not given
- Phase
- Phase 3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Histologically confirmed newly diagnosed low-grade gliomas
- Karnofsky performance status of 60 or more
Who cannot join
- Previous history of radiation therapy or chemotherapy for gliomas
- Pregnant or breast feeding
- Diagnosis of another malignancy may exclude subject from study
- Evidence or history of bleeding diathesis
- Evidence or history of hypersensitivity to temozolomide
Trial locations and contacts
1 site in 1 country.
About this study
Although the prognosis of patients with low-grade glioma (LGG) is generally good, recurrence seems unavoidable in some patients because of the infiltrative growth of the tumors. How to treat LGGs is still under controversy. The role of radiation therapy and chemotherapy in the treatment of LGG need to be further investigated. The purpose of this study is the following:
- to investigate the role of early radiation therapy in MRI-determined total resected LGGs;
- to compare the efficacy of early radiation therapy and that of initial chemotherapy in the LGGs without total resection.
- Conditions
- Astrocytomas, Oligodendrogliomas, Oligoastrocytoma
- Being tested
- Radiation therapy, Temozolomide
- Medical subject headings
- Astrocytoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
TemozolomideDrug
| Study group | Role | What they receive |
|---|---|---|
| Total resection with early radiation | Experimental | Total resected LGGs treated with early radiation Receives: Radiation: Radiation therapy |
| Total resection without radiation | No intervention | Total resected LGGs treated without radiation |
| Residual LGGs with radiation | Experimental | Residual LGGs treated with early radiation Receives: Radiation: Radiation therapy |
| Residual LGGs with chemo | Experimental | Residual LGGS treated with temozolomide Receives: Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival.
Measured: 10 years
Efficacy of early radiation therapy vs. initial chemotherapy with temozolomide in LGGs without total resection: evaluated as 5-year progression-free survival.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startDec 2007
Why it stopped: Difficulty in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstrocytomasStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Zhongping Chen, M.D., Ph.D., Study chair, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897377
- Sponsor's protocol ID
- YP2008009
- Status last verified
- May 2009
- First submitted
- 8 May 2009
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Strategy for Low-grade Gliomas
- ClinicalTrials.gov ID
- NCT00897377
- Acronym / sponsor ID
- YP2008009
- Conditions
- Astrocytomas, Oligodendrogliomas, Oligoastrocytoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting patients
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2007
- First posted
- 12 May 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.
Although the prognosis of patients with low-grade glioma (LGG) is generally good, recurrence seems unavoidable in some patients because of the infiltrative growth of the tumors. How to treat LGGs is still under controversy. The role of radiation therapy and chemotherapy in the treatment of LGG need to be further investigated. The purpose of this study is the following:
- to investigate the role of early radiation therapy in MRI-determined total resected LGGs;
- to compare the efficacy of early radiation therapy and that of initial chemotherapy in the LGGs without total resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Total resection with early radiation | Experimental | Radiation: Radiation therapyTotal resected LGGs treated with early radiation |
| Total resection without radiation | No intervention | –Total resected LGGs treated without radiation |
| Residual LGGs with radiation | Experimental | Radiation: Radiation therapyResidual LGGs treated with early radiation |
| Residual LGGs with chemo | Experimental | Drug: TemozolomideResidual LGGS treated with temozolomide |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Histologically confirmed newly diagnosed low-grade gliomas
- Karnofsky performance status of 60 or more
Key exclusion criteria (5 listed)
- Previous history of radiation therapy or chemotherapy for gliomas
- Pregnant or breast feeding
- Diagnosis of another malignancy may exclude subject from study
- Evidence or history of bleeding diathesis
- Evidence or history of hypersensitivity to temozolomide
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 |
|---|---|---|
| Radiation therapy | Radiation | Residual LGGs with radiation, Total resection with early radiation |
| Temozolomide | Drug | Residual LGGs with chemo |
Primary outcome
Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival.
Time frame: 10 years
Efficacy of early radiation therapy vs. initial chemotherapy with temozolomide in LGGs without total resection: evaluated as 5-year progression-free survival.
Time frame: 10 years
Results and safety
The study was stopped early (reason given: Difficulty in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 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.
Zhongping Chen, M.D., Ph.D. study chair
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiation therapy and Temozolomide in people with Astrocytomas and Oligodendrogliomas, run by Sun Yat-sen 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 2 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: stopped early, as of the sponsor's last update on 5 Aug 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Difficulty in recruiting patients). 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?
Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival. (time frame: 10 years). The study lists 2 primary outcomes in all. 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 5 Aug 2014.