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NCT04829097
Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma
Phase 3 trial testing Temozolomide in Glioblastoma in 80 participants. Status unknown.
1 November 2023
Quick facts
| Lead sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 November 2020 |
| Primary completion | 1 November 2023 |
| Estimated completion | 1 November 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Temozolomide (temozolomide) — full drug profile →
Conditions studied
- Glioblastoma — all drugs for Glioblastoma →
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Who can join
Adults 18 to 70, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a prospective, multi-center, randomized controlled clinical study. Indications: Glioblastoma diagnosed after surgery (WHO grade IV). The patient received conventional postoperative concurrent radiotherapy and chemotherapy, or neoadjuvant temozolomide combined with concurrent increased intensity-modulated radiotherapy. According to data from previous clinical trials, conventional doses of concurrent radiotherapy and chemotherapy PFS 6.9 months neoadjuvant temozolomide combined with concurrently increased intensity-modulated radiotherapy PFS 13.7 months, an estimated 20% leakage rate, and a total sample size of 80 patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04829097
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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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 NCT04829097 (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 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Last refreshed: 2 April 2021
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/NCT04829097.
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