Anaplastic OligoastrocytomaPhase 3NCT01765088
A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas
A Phase 3 study testing Temozolomide and α-IFN in people with Anaplastic Oligoastrocytoma and Anaplastic Astrocytoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anaplastic Oligoastrocytoma, Anaplastic Astrocytoma, Glioblastoma
- What is being tested?
- Temozolomide and α-IFN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Dec 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years to 75 years
- newly diagnosed WHO III-IV glioma after operation and radiotherapy
- Karnofsky Performance Score ≥ 60
- Adequate bone marrow, liver and renal function
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent
- anticipating survival ≥2 months
Who cannot join
- Refusal to participate the study
- Known hypersensitivity or contraindication to temozolomide
- Incompletely radiation
- Pregnant or lactating females
- Malignant tumor other than brain tumor
- Contraindicated for MRI examination
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- Unable to comply with the follow-up studies of this trial
- Purulent and chronic infected wounds
- Uncontrolled psychotic disorders or epilepsy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhong-ping Chen, MD,PhD, +86-20-87343310, chenzhp@sysucc.org.cn
Cheng-cheng Guo, MD,PhD, +86-20-87343656, guochch@sysucc.org.cn
About this study
Official title: A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas
This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma.
Read the detailed description
This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma. Four weeks after radiotherapy, newly diagnosed WHO III-IV glioma patients will be randomised into two groups: TMZ group or TMZ+ α-IFN groups.
- Being tested
- Temozolomide, α-IFN
- Keywords
- High-grade glioma, chemotherapy, Temozolomide, Interferon-alpha
- Medical subject headings
- Astrocytoma, Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodar
dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days
α-IFNDrug
Also called INTRONA
3mIU (3million) D1，3，5
| Study group | Role | What they receive |
|---|---|---|
| temozolomide | Active comparator | Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide (150 mg/m^2 daily on Days 1-5 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles) Receives: Drug: Temozolomide |
| temozolomide +α-IFN | Experimental | Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus α-IFN α-IFN：3mIU (3million) Day1,3,5 of each 28 day TMZ：150 mg/m^2 daily on Days 2-6 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles Receives: Drug: Temozolomide; Drug: α-IFN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Over-all survival
Measured: 5-year
Secondary outcomes (1)
Quality of life
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2017
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anaplastic OligoastrocytomaStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongping Chen, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765088
- Sponsor's protocol ID
- CSNO2012001
- Status last verified
- Feb 2018
- First submitted
- 7 Jan 2013
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guo C, Yang Q, Xu P, Deng M, Jiang T, Cai L, Li J, Sai K, Xi S, Ouyang H, Liu M, Li X, Li Z, Ni X, Cao X, Li C, Wu S, Du X, Su J, Xue X, Wang Y, Li G, Qin Z, Yang H, Zhou T, Liu J, Hu X, Wang J, Jiang X, Lin F, Zhang X, Ke C, Lv X, Lv Y, Hu W, Zeng J, Chen Z, Zhong S, Wang H, Chen Y, Zhang J, Li D, Mou Y, Chen Z. Adjuvant Temozolomide Chemotherapy With or Without Interferon Alfa Among Patients With Newly Diagnosed High-grade Gliomas: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2253285. doi: 10.1001/jamanetworkopen.2022.53285.
PubMed 36705923
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas
- ClinicalTrials.gov ID
- NCT01765088
- Acronym / sponsor ID
- CSNO2012001
- Keywords
- High-grade glioma, chemotherapy, Temozolomide, Interferon-alpha
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 10 Jan 2013 (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.
This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma.
Detailed description
This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma. Four weeks after radiotherapy, newly diagnosed WHO III-IV glioma patients will be randomised into two groups: TMZ group or TMZ+ α-IFN groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| temozolomide | Active comparator | Drug: TemozolomideFour weeks after radiotherapy, patients will be received 6 cycle of temozolomide (150 mg/m^2 daily on Days 1-5 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles) |
| temozolomide +α-IFN | Experimental | Drug: Temozolomide, Drug: α-IFNFour weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus α-IFN α-IFN：3mIU (3million) Day1,3,5 of each 28 day TMZ：150 mg/m^2 daily on Days 2-6 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18 years to 75 years
- newly diagnosed WHO III-IV glioma after operation and radiotherapy
- Karnofsky Performance Score ≥ 60
- Adequate bone marrow, liver and renal function
- Ability of subject to understand character and individual consequences of the clinical trial
Key exclusion criteria (9 listed)
- Refusal to participate the study
- Known hypersensitivity or contraindication to temozolomide
- Incompletely radiation
- Pregnant or lactating females
- Malignant tumor other than brain tumor
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 |
|---|---|---|
| TemozolomideAlso: Temodardosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days | Drug | temozolomide, temozolomide +α-IFN |
| α-IFNAlso: INTRONA3mIU (3million) D1，3，5 | Drug | temozolomide +α-IFN |
Primary outcome
Over-all survival
Time frame: 5-year
1 secondary outcome
Quality of life
Time frame: 5-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Derived from this study: PubMed 36705923Guo C, Yang Q, Xu P, Deng M, Jiang T, Cai L, Li J, Sai K, Xi S, Ouyang H, Liu M, Li X, Li Z, Ni X, Cao X, Li C, Wu S, Du X, Su J, Xue X, Wang Y, Li G, Qin Z, Yang H, Zhou T, Liu J, Hu X, Wang J, Jiang X, Lin F, Zhang X, Ke C, Lv X, Lv Y, Hu W, Zeng J, Chen Z, Zhong S, Wang H, Chen Y, Zhang J, Li D, Mou Y, Chen Z. Adjuvant Temozolomide Chemotherapy With or Without Interferon Alfa Among Patients With Newly Diagnosed High-grade Gliomas: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2253285. doi: 10.1001/jamanetworkopen.2022.53285.
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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.
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 Temozolomide and α-IFN in people with Anaplastic Oligoastrocytoma and Anaplastic Astrocytoma, 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 7 inclusion and 9 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 23 Feb 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhong-ping CHEN, MD, PhD (+86-20-87343310, chenzhp@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Over-all survival (time frame: 5-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01765088, which also lists 1 linked publication.
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 23 Feb 2018.