Grade II/III GliomaEarly Phase 1NCT02766270
CCRT With Temozolomide Versus RT Alone in Patients With IDH Wild-type/TERT Promoter Mutation Grade II/III Gliomas
A Early Phase 1 study testing Temozolomide and Radiotherapy in people with Grade II/III Glioma, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The management of lower-grade gliomas (Diffuse low-grade and intermediate-grade gliomas, WHO II and III) is largely based on surgery followed by radiotherapy. Recent studies showed that lower-grade glioma patients with IDH wild-type (IDH-wt) and TERT promoter mutation (TERTp-mut) had dismal clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Grade II/III Glioma
- What is being tested?
- Temozolomide and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2016to Dec 2018
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed supratentorial Diffuse low-grade and intermediate-grade gliomas (World Health Organization grades II and III )
- IDH wild-type and TERT promoter mutation
- Age > 18
- Karnofsky performance score > 60
- Neutrophilic granulocyte count > 1500/µl
- Platelet count > 100 000/µl
Show all 13Show fewer
- Hemoglobin > 10 g/dl
- Serum creatinine < 1.5 times the lab's upper normal limit
- AST or ALT < 1.5 times the lab's upper normal limit
- Adequate medical health to participate in this study
- No previous systemic chemotherapy
- No previous radiotherapy to the brain
- Written informed consent
Who cannot join
- Serious medical or neurological condition with a poor prognosis
- Contraindications to radiotherapy or temozolomide chemotherapy
- Patient unable to follow procedures, visits, examinations described in the study
- Second cancer requiring radiotherapy or chemotherapy
- Inability to undergo gadolinium-contrasted MRIs
- Pregnant women or nursing mothers can not participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Xiao-Guang Qiu, M.D., ttyy6611@126.com
Tao Jiang, M.D.
About this study
Official title: A Prospective Study of Concurrent Chemoradiotherapy With Temozolomide Versus Radiation Therapy Alone in Patients With IDH Wild-type/TERT Promoter Mutation Grade II/III Gliomas
The management of lower-grade gliomas (Diffuse low-grade and intermediate-grade gliomas, WHO II and III) is largely based on surgery followed by radiotherapy. Recent studies showed that lower-grade glioma patients with IDH wild-type (IDH-wt) and TERT promoter mutation (TERTp-mut) had dismal clinical outcomes. These results suggested that current treatment strategies are not adequate for this subtype of lower-grade glioma.
The present study aims to examine the efficacy and safety of concurrent chemoradiotherapy with temozolomide followed by adjuvant temozolomide for lower- grade glioma patients with IDH-wt and TERTp-mut.
Read the detailed description
Diffuse low-grade and intermediate-grade gliomas (which together make up the lower-grade gliomas, World Health Organization grades II and III) are infiltrative neoplasms that arise most often in the cerebral hemispheres of adults and include astrocytomas, oligodendrogliomas, and oligoastrocytomas. The management of lower-grade gliomas is largely based on surgery followed by radiotherapy.
Lower-grade gliomas have highly variable clinical behavior that is not adequately predicted on the basis of histologic class. Consequently, clinicians increasingly rely on genetic classification to guide clinical decision making. Mutations in IDH1 and IDH2 characterize the majority of lower-grade gliomas in adults and define a subtype that is associated with a favorable prognosis. Mutations of the telomerase reverse transcriptase (TERT) promoter, which result in enhanced telomerase activity and lengthened telomeres, have been observed in several human cancers including glioma. Accumulating evidence suggest that TERT promoter mutation is another molecular marker which can stratify lower-grade gliomas into prognostic subgroups in combination with IDH mutation. In our previous study, patients(28/377, 7.4%) who had lower-grade gliomas with IDH wild-type (IDH-wt) and TERT promoter mutation (TERTp-mut) had the poorest clinical outcomes (median OS, 27.7mo; 5-year OS, 29%). These results were accordant with the recent studies and suggested that current treatment strategies are not adequate for this subtype of lower-grade glioma.
Radiotherapy plus temozolomide has emerged as a new standard of care for patients with good PS non-elderly glioblastoma. There are some data that support temozolomide as adjuvant therapy for lower-grade glioma. Given that the IDH-wt/TERTp-mut subgroup of lower-grade gliomas has dismal prognosis, a more aggressive therapy such as concurrent chemoradiotherapy seems to be reasonable. The present study aims to examine the efficacy and safety of concurrent chemoradiotherapy with temozolomide followed by adjuvant temozolomide for lower-grade glioma patients with IDH-wt and TERTp-mut. Half the patients will be randomly assigned to receive concurrent chemoradiotherapy (surgery + concurrent chemoradiotherapy with temozolomide followed by adjuvant temozolomide) and half the patients will be randomly assigned to receive conventional therapy (surgery + radiotherapy only).
- Conditions
- Grade II/III Glioma
- Being tested
- Temozolomide, Radiotherapy
- Keywords
- Grade II/III Glioma, IDH, TERT, Chemoradiotherapy, Temozolomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
RT with daily temozolomide (75 mg/m2/day, 7 days/week for up to 7 weeks) and adjuvant temozolomide (150-200 mg/m2 PO QD for 5 days, repeats every 28 days for up to 12 courses).
RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiotherapy with Temozolomide | Experimental | Patients undergo intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy 5 days a week for 6 weeks (for a total of 60 Gy) and receive temozolomide PO QD (75 mg/m2/day, 7 days/week) for up to 7 weeks. Beginning 4 weeks after completion of chemotherapy and radiation therapy, patients receive temozolomide PO QD on days 1-5 (150-200 mg/m2). Treatment with temozolomide repeats every 28 days for up to 12 courses Receives: Drug: Temozolomide; Radiation: Radiotherapy |
| Radiotherapy alone | Active comparator | Patients undergo intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy 5 days a week for 6 weeks (for a total of 60 Gy) Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall survival is defined as the time from randomization to death.
Measured: Up to 2 years
Secondary outcomes (2)
Progression free survival(PFS)
Progression free survival(PFS) is defined as the time from randomization to progressive disease or death. A combination of neurological examination and MRI brain scan used to define progression.
Measured: Up to 2 years
The incidence and severity of adverse events associated with treatment with RT alone and combined with temozolomide chemotherapy; according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study start26 Sep 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Grade II/III GliomaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Neurosurgical Institute, Beijing Shijitan Hospital, Capital Medical University
- Responsible party
- Principal investigator, Tao Jiang, Beijing Tiantan Hospital
- Investigators
- Tao Jiang, M.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766270
- Sponsor's protocol ID
- CFMD 2016-2-1073
- Status last verified
- Jan 2017
- First submitted
- 4 May 2016
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Yan H, Parsons DW, Jin G, McLendon R, Rasheed BA, Yuan W, Kos I, Batinic-Haberle I, Jones S, Riggins GJ, Friedman H, Friedman A, Reardon D, Herndon J, Kinzler KW, Velculescu VE, Vogelstein B, Bigner DD. IDH1 and IDH2 mutations in gliomas. N Engl J Med. 2009 Feb 19;360(8):765-73. doi: 10.1056/NEJMoa0808710.
PubMed 19228619Parsons DW, Jones S, Zhang X, Lin JC, Leary RJ, Angenendt P, Mankoo P, Carter H, Siu IM, Gallia GL, Olivi A, McLendon R, Rasheed BA, Keir S, Nikolskaya T, Nikolsky Y, Busam DA, Tekleab H, Diaz LA Jr, Hartigan J, Smith DR, Strausberg RL, Marie SK, Shinjo SM, Yan H, Riggins GJ, Bigner DD, Karchin R, Papadopoulos N, Parmigiani G, Vogelstein B, Velculescu VE, Kinzler KW. An integrated genomic analysis of human glioblastoma multiforme. Science. 2008 Sep 26;321(5897):1807-12. doi: 10.1126/science.1164382. Epub 2008 Sep 4.
PubMed 18772396Killela PJ, Reitman ZJ, Jiao Y, Bettegowda C, Agrawal N, Diaz LA Jr, Friedman AH, Friedman H, Gallia GL, Giovanella BC, Grollman AP, He TC, He Y, Hruban RH, Jallo GI, Mandahl N, Meeker AK, Mertens F, Netto GJ, Rasheed BA, Riggins GJ, Rosenquist TA, Schiffman M, Shih IeM, Theodorescu D, Torbenson MS, Velculescu VE, Wang TL, Wentzensen N, Wood LD, Zhang M, McLendon RE, Bigner DD, Kinzler KW, Vogelstein B, Papadopoulos N, Yan H. TERT promoter mutations occur frequently in gliomas and a subset of tumors derived from cells with low rates of self-renewal. Proc Natl Acad Sci U S A. 2013 Apr 9;110(15):6021-6. doi: 10.1073/pnas.1303607110. Epub 2013 Mar 25.
PubMed 23530248Nonoguchi N, Ohta T, Oh JE, Kim YH, Kleihues P, Ohgaki H. TERT promoter mutations in primary and secondary glioblastomas. Acta Neuropathol. 2013 Dec;126(6):931-7. doi: 10.1007/s00401-013-1163-0. Epub 2013 Aug 17.
PubMed 23955565Yang P, Cai J, Yan W, Zhang W, Wang Y, Chen B, Li G, Li S, Wu C, Yao K, Li W, Peng X, You Y, Chen L, Jiang C, Qiu X, Jiang T; CGGA project. Classification based on mutations of TERT promoter and IDH characterizes subtypes in grade II/III gliomas. Neuro Oncol. 2016 Aug;18(8):1099-108. doi: 10.1093/neuonc/now021. Epub 2016 Mar 7.
PubMed 26957363Chan AK, Yao Y, Zhang Z, Chung NY, Liu JS, Li KK, Shi Z, Chan DT, Poon WS, Zhou L, Ng HK. TERT promoter mutations contribute to subset prognostication of lower-grade gliomas. Mod Pathol. 2015 Feb;28(2):177-86. doi: 10.1038/modpathol.2014.94. Epub 2014 Aug 1.
PubMed 25081751Labussiere M, Di Stefano AL, Gleize V, Boisselier B, Giry M, Mangesius S, Bruno A, Paterra R, Marie Y, Rahimian A, Finocchiaro G, Houlston RS, Hoang-Xuan K, Idbaih A, Delattre JY, Mokhtari K, Sanson M. TERT promoter mutations in gliomas, genetic associations and clinico-pathological correlations. Br J Cancer. 2014 Nov 11;111(10):2024-32. doi: 10.1038/bjc.2014.538. Epub 2014 Oct 14.
PubMed 25314060Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.
PubMed 19269895Quinn JA, Reardon DA, Friedman AH, Rich JN, Sampson JH, Provenzale JM, McLendon RE, Gururangan S, Bigner DD, Herndon JE 2nd, Avgeropoulos N, Finlay J, Tourt-Uhlig S, Affronti ML, Evans B, Stafford-Fox V, Zaknoen S, Friedman HS. Phase II trial of temozolomide in patients with progressive low-grade glioma. J Clin Oncol. 2003 Feb 15;21(4):646-51. doi: 10.1200/JCO.2003.01.009.
PubMed 12586801Zhang J, Wang P, Ren Y, Chen L, Feng J, Liu F, Deng K, Bao Z, Qiu X, Liu Y. Chemoradiotherapy with temozolomide vs. radiotherapy alone in patients with IDH wild-type and TERT promoter mutation histological grade 2/3 gliomas: An extension retrospective analysis of a randomized controlled trial. Cancer. 2025 Dec 1;131(23):e70171. doi: 10.1002/cncr.70171.
PubMed 41328764Qiu X, Chen Y, Bao Z, Chen L, Jiang T. Chemoradiotherapy with temozolomide vs. radiotherapy alone in patients with IDH wild-type and TERT promoter mutation WHO grade II/III gliomas: A prospective randomized study. Radiother Oncol. 2022 Feb;167:1-6. doi: 10.1016/j.radonc.2021.12.009. Epub 2021 Dec 10.
PubMed 34902368
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Concurrent Chemoradiotherapy With Temozolomide Versus Radiation Therapy Alone in Patients With IDH Wild-type/TERT Promoter Mutation Grade II/III Gliomas
- ClinicalTrials.gov ID
- NCT02766270
- Acronym / sponsor ID
- CFMD 2016-2-1073
- Conditions
- Grade II/III Glioma
- Keywords
- Grade II/III Glioma, IDH, TERT, Chemoradiotherapy, Temozolomide
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Neurosurgical Institute, Beijing Shijitan Hospital, Capital Medical University
- Study start
- 26 Sep 2016 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 May 2016 (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 management of lower-grade gliomas (Diffuse low-grade and intermediate-grade gliomas, WHO II and III) is largely based on surgery followed by radiotherapy. Recent studies showed that lower-grade glioma patients with IDH wild-type (IDH-wt) and TERT promoter mutation (TERTp-mut) had dismal clinical outcomes. These results suggested that current treatment strategies are not adequate for this subtype of lower-grade glioma.
The present study aims to examine the efficacy and safety of concurrent chemoradiotherapy with temozolomide followed by adjuvant temozolomide for lower- grade glioma patients with IDH-wt and TERTp-mut.
Detailed description
Diffuse low-grade and intermediate-grade gliomas (which together make up the lower-grade gliomas, World Health Organization grades II and III) are infiltrative neoplasms that arise most often in the cerebral hemispheres of adults and include astrocytomas, oligodendrogliomas, and oligoastrocytomas. The management of lower-grade gliomas is largely based on surgery followed by radiotherapy.
Lower-grade gliomas have highly variable clinical behavior that is not adequately predicted on the basis of histologic class. Consequently, clinicians increasingly rely on genetic classification to guide clinical decision making. Mutations in IDH1 and IDH2 characterize the majority of lower-grade gliomas in adults and define a subtype that is associated with a favorable prognosis. Mutations of the telomerase reverse transcriptase (TERT) promoter, which result in enhanced telomerase activity and lengthened telomeres, have been observed in several human cancers including glioma. Accumulating evidence suggest that TERT promoter mutation is another molecular marker which can stratify lower-grade gliomas into prognostic subgroups in combination with IDH mutation. In our previous study, patients(28/377, 7.4%) who had lower-grade gliomas with IDH wild-type (IDH-wt) and TERT promoter mutation (TERTp-mut) had the poorest clinical outcomes (median OS, 27.7mo; 5-year OS, 29%). These results were accordant with the recent studies and suggested that current treatment strategies are not adequate for this subtype of lower-grade glioma.
Radiotherapy plus temozolomide has emerged as a new standard of care for patients with good PS non-elderly glioblastoma. There are some data that support temozolomide as adjuvant therapy for lower-grade glioma. Given that the IDH-wt/TERTp-mut subgroup of lower-grade gliomas has dismal prognosis, a more aggressive therapy such as concurrent chemoradiotherapy seems to be reasonable. The present study aims to examine the efficacy and safety of concurrent chemoradiotherapy with temozolomide followed by adjuvant temozolomide for lower-grade glioma patients with IDH-wt and TERTp-mut. Half the patients will be randomly assigned to receive concurrent chemoradiotherapy (surgery + concurrent chemoradiotherapy with temozolomide followed by adjuvant temozolomide) and half the patients will be randomly assigned to receive conventional therapy (surgery + radiotherapy only).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemoradiotherapy with Temozolomide | Experimental | Drug: Temozolomide, Radiation: RadiotherapyPatients undergo intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy 5 days a week for 6 weeks (for a total of 60 Gy) and receive temozolomide PO QD (75 mg/m2/day, 7 days/week) for up to 7 weeks. Beginning 4 weeks after completion of chemotherapy and radiation therapy, patients receive temozolomide PO QD on days 1-5 (150-200 mg/m2). Treatment with temozolomide repeats every 28 days for up to 12 courses |
| Radiotherapy alone | Active comparator | Radiation: RadiotherapyPatients undergo intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy 5 days a week for 6 weeks (for a total of 60 Gy) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed supratentorial Diffuse low-grade and intermediate-grade gliomas (World Health Organization grades II and III )
- IDH wild-type and TERT promoter mutation
- Age > 18
- Karnofsky performance score > 60
- Neutrophilic granulocyte count > 1500/µl
Key exclusion criteria (6 listed)
- Serious medical or neurological condition with a poor prognosis
- Contraindications to radiotherapy or temozolomide chemotherapy
- Patient unable to follow procedures, visits, examinations described in the study
- Second cancer requiring radiotherapy or chemotherapy
- Inability to undergo gadolinium-contrasted MRIs
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 |
|---|---|---|
| TemozolomideRT with daily temozolomide (75 mg/m2/day, 7 days/week for up to 7 weeks) and adjuvant temozolomide (150-200 mg/m2 PO QD for 5 days, repeats every 28 days for up to 12 courses). | Drug | Chemoradiotherapy with Temozolomide |
| Radiotherapy | Radiation | Chemoradiotherapy with Temozolomide, Radiotherapy alone |
Primary outcome
Overall survival (OS)
Time frame: Up to 2 years
Overall survival is defined as the time from randomization to death.
2 secondary outcomes
Progression free survival(PFS)
Time frame: Up to 2 years
The incidence and severity of adverse events associated with treatment with RT alone and combined with temozolomide chemotherapy; according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Background: PubMed 19228619Yan H, Parsons DW, Jin G, McLendon R, Rasheed BA, Yuan W, Kos I, Batinic-Haberle I, Jones S, Riggins GJ, Friedman H, Friedman A, Reardon D, Herndon J, Kinzler KW, Velculescu VE, Vogelstein B, Bigner DD. IDH1 and IDH2 mutations in gliomas. N Engl J Med. 2009 Feb 19;360(8):765-73. doi: 10.1056/NEJMoa0808710.
- Background: PubMed 18772396Parsons DW, Jones S, Zhang X, Lin JC, Leary RJ, Angenendt P, Mankoo P, Carter H, Siu IM, Gallia GL, Olivi A, McLendon R, Rasheed BA, Keir S, Nikolskaya T, Nikolsky Y, Busam DA, Tekleab H, Diaz LA Jr, Hartigan J, Smith DR, Strausberg RL, Marie SK, Shinjo SM, Yan H, Riggins GJ, Bigner DD, Karchin R, Papadopoulos N, Parmigiani G, Vogelstein B, Velculescu VE, Kinzler KW. An integrated genomic analysis of human glioblastoma multiforme. Science. 2008 Sep 26;321(5897):1807-12. doi: 10.1126/science.1164382. Epub 2008 Sep 4.
- Background: PubMed 23530248Killela PJ, Reitman ZJ, Jiao Y, Bettegowda C, Agrawal N, Diaz LA Jr, Friedman AH, Friedman H, Gallia GL, Giovanella BC, Grollman AP, He TC, He Y, Hruban RH, Jallo GI, Mandahl N, Meeker AK, Mertens F, Netto GJ, Rasheed BA, Riggins GJ, Rosenquist TA, Schiffman M, Shih IeM, Theodorescu D, Torbenson MS, Velculescu VE, Wang TL, Wentzensen N, Wood LD, Zhang M, McLendon RE, Bigner DD, Kinzler KW, Vogelstein B, Papadopoulos N, Yan H. TERT promoter mutations occur frequently in gliomas and a subset of tumors derived from cells with low rates of self-renewal. Proc Natl Acad Sci U S A. 2013 Apr 9;110(15):6021-6. doi: 10.1073/pnas.1303607110. Epub 2013 Mar 25.
- Background: PubMed 23955565Nonoguchi N, Ohta T, Oh JE, Kim YH, Kleihues P, Ohgaki H. TERT promoter mutations in primary and secondary glioblastomas. Acta Neuropathol. 2013 Dec;126(6):931-7. doi: 10.1007/s00401-013-1163-0. Epub 2013 Aug 17.
- Background: PubMed 26957363Yang P, Cai J, Yan W, Zhang W, Wang Y, Chen B, Li G, Li S, Wu C, Yao K, Li W, Peng X, You Y, Chen L, Jiang C, Qiu X, Jiang T; CGGA project. Classification based on mutations of TERT promoter and IDH characterizes subtypes in grade II/III gliomas. Neuro Oncol. 2016 Aug;18(8):1099-108. doi: 10.1093/neuonc/now021. Epub 2016 Mar 7.
- Background: PubMed 25081751Chan AK, Yao Y, Zhang Z, Chung NY, Liu JS, Li KK, Shi Z, Chan DT, Poon WS, Zhou L, Ng HK. TERT promoter mutations contribute to subset prognostication of lower-grade gliomas. Mod Pathol. 2015 Feb;28(2):177-86. doi: 10.1038/modpathol.2014.94. Epub 2014 Aug 1.
- Background: PubMed 25314060Labussiere M, Di Stefano AL, Gleize V, Boisselier B, Giry M, Mangesius S, Bruno A, Paterra R, Marie Y, Rahimian A, Finocchiaro G, Houlston RS, Hoang-Xuan K, Idbaih A, Delattre JY, Mokhtari K, Sanson M. TERT promoter mutations in gliomas, genetic associations and clinico-pathological correlations. Br J Cancer. 2014 Nov 11;111(10):2024-32. doi: 10.1038/bjc.2014.538. Epub 2014 Oct 14.
- Background: PubMed 19269895Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.
- Background: PubMed 12586801Quinn JA, Reardon DA, Friedman AH, Rich JN, Sampson JH, Provenzale JM, McLendon RE, Gururangan S, Bigner DD, Herndon JE 2nd, Avgeropoulos N, Finlay J, Tourt-Uhlig S, Affronti ML, Evans B, Stafford-Fox V, Zaknoen S, Friedman HS. Phase II trial of temozolomide in patients with progressive low-grade glioma. J Clin Oncol. 2003 Feb 15;21(4):646-51. doi: 10.1200/JCO.2003.01.009.
- Derived from this study: PubMed 41328764Zhang J, Wang P, Ren Y, Chen L, Feng J, Liu F, Deng K, Bao Z, Qiu X, Liu Y. Chemoradiotherapy with temozolomide vs. radiotherapy alone in patients with IDH wild-type and TERT promoter mutation histological grade 2/3 gliomas: An extension retrospective analysis of a randomized controlled trial. Cancer. 2025 Dec 1;131(23):e70171. doi: 10.1002/cncr.70171.
- Derived from this study: PubMed 34902368Qiu X, Chen Y, Bao Z, Chen L, Jiang T. Chemoradiotherapy with temozolomide vs. radiotherapy alone in patients with IDH wild-type and TERT promoter mutation WHO grade II/III gliomas: A prospective randomized study. Radiother Oncol. 2022 Feb;167:1-6. doi: 10.1016/j.radonc.2021.12.009. Epub 2021 Dec 10.
- Individual participant dataSharing planned: Undecided
Related trials for Grade II/III Glioma
Active, not recruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
Not yet recruitingPhase 3
HMPL-306 in Participants With Postoperative Residual or Recurrent Grade 2 Glioma Harboring IDH1 or IDH2 Mutations
Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
RecruitingPhase 1
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
Adult Glioblastoma, High Grade Glioma
Active, not recruitingPhase 1
Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma
Recurrent Glioblastoma, Recurrent Malignant Glioma
RecruitingEarly Phase 1
Implantable Microdevice In Primary Brain Tumors
Grade II Glioma, Grade III Glioma
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.
Tao Jiang, M.D. principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Temozolomide and Radiotherapy in people with Grade II/III Glioma, run by Beijing Tiantan 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 13 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 20 Jan 2017. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Xiao-Guang Qiu, M.D. (0086-010-67096611, ttyy6611@126.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: Up to 2 years). 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 NCT02766270, which also lists 11 linked publications.
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 20 Jan 2017.