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NCT00978458
Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
Phase 3 trial testing temozolomide in Brain and Central Nervous System Tumors in 540 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2026
Quick facts
| Lead sponsor | Eastern Cooperative Oncology Group |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Primary purpose | treatment |
| Enrollment | 540 |
| Start date | 17 November 2009 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 168 locations across United States |
Drugs / interventions tested
- temozolomide (temozolomide) — full drug profile →
- 3-dimensional conformal radiation therapy
- intensity-modulated radiation therapy
Conditions studied
- Brain and Central Nervous System Tumors — all drugs for Brain and Central Nervous System Tumors →
- Neurotoxicity — all drugs for Neurotoxicity →
Sponsor
Eastern Cooperative Oncology Group
Who can join
Adults 18 to 120, any sex, with Brain and Central Nervous System Tumors or Neurotoxicity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with or without temozolomide in treating patients with low-grade glioma. PURPOSE: This randomized phase III trial is studying radiation therapy so see how well it works when given together with or without temozolomide in treating patients with low-grade glioma.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Low-grade gliomas.
Forst DA, Nahed BV, Loeffler JS, Batchelor TT. · · 2014 · cited 171× · PMID 24664484 · DOI 10.1634/theoncologist.2013-0345 -
Early versus delayed postoperative radiotherapy for treatment of low-grade gliomas.
Dhawan S, Patil CG, Chen C, Venteicher AS. · · 2020 · cited 23× · PMID 31958162 · DOI 10.1002/14651858.cd009229.pub3 -
Radiation therapy and grade II/III oligodendroglial tumors.
Chung C, Laperriere N. · · 2015 · cited 7× · PMID 26477980 · DOI 10.2217/cns.15.25 -
Current and Future Frontiers of Molecularly Defined Oligodendrogliomas.
Rincon-Torroella J, Rakovec M, Materi J, Raj D, et al · · 2022 · cited 5× · PMID 35957904 · DOI 10.3389/fonc.2022.934426
Verify or expand the search:
- PubMed search for NCT00978458
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT04400188 — A Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cel · Phase 1, PHASE2 · completed
- NCT03514069 — Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma · Phase 1 · active not recruiting
- NCT02168270 — Temozolomide and Ascorbic Acid in Treating Patients With Recurrent High-Grade Glioma · Phase 1 · terminated
Other Eastern Cooperative Oncology Group trials
Trials by the same sponsor.
- NCT07068074 — A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients · Phase 3 · not yet recruiting
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- NCT07122492 — A Targeted Electronic Health Approach to Reduce Fear of Recurrence in Breast Cancer Survivors (FoRtitude) · NA · not yet recruiting
- NCT07085728 — Testing the Investigational Agent Combination of Daratumumab, Bortezomib, and Dexamethasone Compared to the Usual Treatm · Phase 2 · not yet recruiting
- NCT06756607 — The ECOG-ACRIN SUPPORT Trial: Multilevel Intervention to Improve Diverse Enrollment in Cancer Clinical Trials · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00978458 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eastern Cooperative Oncology Group
- Last refreshed: 8 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00978458.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing