N/A
Completed N=82
Hypofractionated IMRT With Temozolomide for HGG
Source: ClinicalTrials.gov NCT02082119 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Progression Free Survival (PFS) — 82 Participants — p=<0.05
Summary
To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy, concomitant and adjuvant, in patients with newly diagnosed HGGs after surgery.
Primary endpoint: progression free survival (PFS), Overall Survival (OS) and Toxicity.
Secondary endpoint: to evaluate Quality of life (QoL) of patients after surgery, concomitant chemoradiotherapy and adjuvant chemotherapy through neuropsychological examination.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
82 | <0.05 sig |
| SECONDARY Quality of Life (QoL) of Patients After Surgery, Concomitant Chemo-radiotherapy and Adjuvant Chemotherapy |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 70 years
- Karnosky performance status (KPS) ≥60
- Patients aged >70 years with KPS ≥80
- Histopathologically confirmed of HGG
- Estimated survival ≥ 3 months.
- Multifocal tumor
- Normal liver, Kidney and bone marrow function
- Written informed consent
Exclusion Criteria
- Prior radiation therapy
- KPS ≤ 60
- Age > 70 years and KPS < 70
- Other primary cancer
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT02082119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.