N/A N=82 Treatment

Hypofractionated IMRT With Temozolomide for HGG

Glioma

Bottom Line

View on ClinicalTrials.gov: NCT02082119 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2020

Primary outcome: Primary: Progression Free Survival (PFS) — 82 Participants — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Hypofractionated IMRT (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Istituto Clinico Humanitas
Primary completion: May 2016

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	—	—

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.

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

View full record on ClinicalTrials.gov →

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.