Last reviewed · How we verify
NCT04316039
Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
Phase 2, PHASE3 trial testing Temozolomide in Low-grade Glioma in 250 participants. Currently enrolling.
10 April 2023
Quick facts
| Lead sponsor | West China Hospital |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 250 |
| Start date | 10 April 2018 |
| Primary completion | 10 April 2023 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Temozolomide (temozolomide) — full drug profile →
- intensity modulated radiation therapy
Conditions studied
- Low-grade Glioma — all drugs for Low-grade Glioma →
Sponsor
West China Hospital
Who can join
Adults 18 to 70, any sex, with Low-grade Glioma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
It has been reported that radiation therapy followed by PCV chemotherapy (procarbazine, lomustine and vincristine) could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk WHO grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide to treat these patients, though large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide can improve PFS and OS in patients with high-risk low-grade gliomas.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04316039
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Temozolomide
Trials testing the same drug.
- NCT04373785 — NG101m Adjuvant Therapy in Glioblastoma Patients · Phase 1, PHASE2 · not yet recruiting
- NCT06448286 — PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glio · Phase 3 · not yet recruiting
- NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting
- NCT07452458 — Temporally-Modulated Pulsed Radiation Therapy Versus Standard Radiation Therapy for the Treatment of Newly Diagnosed, ID · Phase 3 · not yet recruiting
- NCT06639607 — PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/Hi · Phase 1, PHASE2 · not yet recruiting
Other recruiting trials for Low-grade Glioma
Currently open trials in the same condition.
- NCT07506239 — Efficacy of Laser Interstitial Thermal Therapy in Young Persons With Low-grade Glioma · NA · recruiting
- NCT07110246 — Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas · Phase 2 · recruiting
- NCT06684795 — FG001 in Subjects with Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery · Phase 2 · recruiting
- NCT06610851 — Monitoring of Patients With Low-grade Gliomas Using Circulating miRNA · recruiting
- NCT06381570 — Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Glioma · EARLY_PHASE1 · recruiting
Other West China Hospital trials
Trials by the same sponsor.
- NCT07583654 — Safety, Tolerability, and Preliminary Antitumor Activity of Cationic Peptide-IL22BP mRNA in Advanced Solid Tumors · Phase 1 · not yet recruiting
- NCT07583914 — Safety, Tolerability, and Preliminary Antitumor Activity of Non-Cationic Peptide-CD47 siRNA in Advanced Solid Tumors · Phase 1 · not yet recruiting
- NCT07492914 — Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma · Phase 2 · recruiting
- NCT07507097 — Study on the Optimal Head Position for Patients With Severe Acute Ischemic Stroke · NA · not yet recruiting
- NCT07472933 — Vebotolimab Combined With Ptorlimab for EGFR-positive Refractory Advanced Biliary Tract Malignancies · Phase 2 · not yet 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 NCT04316039 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by West China Hospital
- Last refreshed: 20 March 2020
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/NCT04316039.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing