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NCT06835803 · ClinicalTrials.gov registry record · Phase 2

Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma: A Phase 2 Hybrid Randomized Trial

A Phase 2 study of Glioblastoma (GBM), sponsored by Brigham and Women's Hospital.

Recruiting
Registry status
Phase 2
Development phase
56
Enrollment target
3
Study locations

NCT06835803: Recruiting Phase 2 study of Glioblastoma (GBM), sponsored by Brigham and Women's Hospital.

NCT06835803 is a Phase 2 study of Glioblastoma (GBM) that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 56 participants, below the 79-participant average among 7 other Glioblastoma (GBM) trials with a reported enrollment target (29% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06835803, a Phase 2 study of Glioblastoma (GBM), is actively recruiting participants, sponsored by Brigham and Women's Hospital.

RECRUITING
Registry status
Phase 2
Development phase
56 participants
Enrollment target
3
Study locations

Study Summary

Glioblastoma (GBM) is an aggressive malignancy of the central nervous system. Older adults with GBM have a unique constellation of medical, psychosocial, and supportive care needs. To address these challenges, prior work has evaluated the feasibility of hypofractionation, a treatment approach delivering fewer, larger radiation dosages over a shorter time period. Common hypofractionated regimens deliver a lower biologically equivalent radiation dose than the conventional regimens used for younger adults. Whether dose escalated hypofractionation can further improve outcomes in older adults remains unclear. This will be a hybrid randomized control trial comparing the efficacy and safety of dose-escalated and standard hypofractionated radiotherapy among older adults with newly-diagnosed glioblastoma compared to standard three-week course. This research study involves the administration of radiation therapy. Radiation will either be delivered at the standard daily dose or at an increased daily dose over a three weeks course of radiation treatment. Research study procedures will include a screening evaluation to assess eligibility, as well as clinical visits for radiation delivery and to assess symptoms during treatment and at scheduled follow-up times. Participants will be randomly assigned to one of the two arms of the trial: 1. Standard hypofractionated radiation over 3 weeks 2. Dose-escalated hypofractionated radiation over 3 weeks

Primary Outcome

through study completion, an average of 1 year

Conditions Studied

Interventions

  • RADIATION Dose-escalated radiation therapy
  • RADIATION Standard hypofractionated radiation

Study Locations (3)

Massachusetts

  • Brigham and Women's Hospital - Boston
  • Dana-Farber Brigham Cancer Center, Milford Hospital - Milford
  • Dana-Farber Brigham Cancer Center, South Shore Hospital - South Weymouth

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2025-04-14
Est. Completion 2029-03-31
Phase Phase 2
Brigham and Women's Hospital

937 total trials

What NCT06835803 shows while recruiting

NCT06835803 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 79-participant average among 7 other Glioblastoma (GBM) trials with a reported enrollment target (29% lower).

The record links to 1 condition, with Glioblastoma (GBM) appearing as the primary indexed condition, and to 2 interventions - of which Dose-escalated radiation therapy is the first listed.

NCT06835803 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06835803 about?

NCT06835803 is a clinical study titled "Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma: A Phase 2 Hybrid Randomized Trial". Glioblastoma (GBM) is an aggressive malignancy of the central nervous system. Older adults with GBM have a unique constellation of medical, psychosocial, and supportive care needs. To address these challenges, prior work has evaluated the feasibility of hypofractionation, a treatment approach delive...

What is the current status of trial NCT06835803?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2025-04-14. Estimated completion is 2029-03-31.

What conditions does trial NCT06835803 study?

This clinical trial studies the following conditions: Glioblastoma (GBM).

What interventions are being tested in trial NCT06835803?

The interventions under investigation include: Dose-escalated radiation therapy (RADIATION), Standard hypofractionated radiation (RADIATION).

Who is sponsoring clinical trial NCT06835803?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06835803 being conducted?

This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT06835803, the US trial registry maintained by the National Library of Medicine. NCT06835803 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.