NCT06055517

Brief Summary

Re-irradiation in gliomas is a therapeutic option at recurrence before of 2nd-line chemotherapy. The dose of re-irradiation with conventional fractionation is unfortunately limited by the risk of symptomatic radionecrosis that is significant for cumulative doses above 100 Gy. The use of unconventional low dose rate pulsed radiotherapy (pLDRT) can reduce the risk of radiotoxicity while taking advantage of the cellular hyper-radiosensitivity that occurs at low dose-rates. The present study therefore aims at evaluating whether the use of pLDRT in the re-irradiation of recurrences of gliomas allows maintaining a low risk of symptomatic radionecrosis even for cumulative doses greater than 100 Gy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
22mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
May 2023May 2028

Study Start

First participant enrolled

May 26, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2028

Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

5 years

First QC Date

September 13, 2023

Last Update Submit

September 20, 2023

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

  • To evaluate the incidence of brain radionecrosis in patients undergoing re-irradiation of brain tumors with pulsed low-dose-rate schedule

    Incidence of grade \>=2 brain radionecrosis in patients undergoing re-irradiation of brain tumors with pulsed low-dose-rate schedule, defined according to CTCAE v5.0 scale

    up to 5 years

Secondary Outcomes (7)

  • To assess the median time to local disease progression

    up to 5 years

  • To assess the median survival time

    up to 5 years

  • To assess the incidence of toxicities other than radionecrosis

    up to 5 years

  • To assess the presence of biomarkers associated with the actinic toxicity

    up to 5 years

  • To assess the presence of biomarkers associated with response to therapy

    up to 5 years

  • +2 more secondary outcomes

Study Arms (1)

Pulsed low dose-rate radiotherapy (pLDRT)

EXPERIMENTAL
Radiation: Pulsed low dose-rate radiotherapy (pLDRT)

Interventions

Pulsed low dose-rate radiotherapy (pLDRT)RADIATION

Radiation treatment will be carried out with high-energy photons (6MV) using intensity modulated radiation therapy (IMRT) or volumetric arc radiation therapy (VMAT). The daily dose is 2 Gy, divided into 10 subfractions of 0.2 Gy spaced by 3 minutes. The cumulative dose will be individualized for each patient and can range from a minimum of 40 Gy to a maximum of 60 Gy.

Pulsed low dose-rate radiotherapy (pLDRT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years;
  • Ability to express appropriate informed consent to treatment;
  • Diagnosis of cerebral glioma;
  • Histological/radiological confirmation of disease recurrence/relapse;
  • Previous brain-level radiation therapy completed a minimum of 6 months;
  • Performance status: ECOG=0-2.

You may not qualify if:

  • Refusal to radiation treatment (i.e., absence of informed consent signed);
  • Concomitant chemotherapy;
  • Leptomeningeal spread of disease and localization in both cerebral hemispheres;
  • Current pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano

Aviano, Pordenone, 33081, Italy

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Lorenzo Vinante, MD

    Centro di Riferimento Oncologico di Aviano (CRO)

    PRINCIPAL INVESTIGATOR

  • Lorena Baboci, PhD

    Centro di Riferimento Oncologico di Aviano (CRO)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Vinante, MD

CONTACT

0434659855lorenzo.vinante@cro.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 26, 2023

Study Start

May 26, 2023

Primary Completion (Estimated)

May 26, 2028

Study Completion (Estimated)

May 26, 2028

Last Updated

September 26, 2023

Record last verified: 2023-09

Locations

IT(1)