Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme

NCT02685605 · View on ClinicalTrials.gov ↗

Study Summary

INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to standard radiochemotherapy.

Conditions Studied

Interventions

  • DRUG Temozolomide
  • PROCEDURE Standard surgery
  • RADIATION Intraoperative radiotherapy
  • RADIATION Radiochemotherapy

Study Locations (19)

Other

  • Hospital Alemão Oswaldo Cruz — São Paulo
  • Beijing Tian Tan Hospital, Capital Medical University — Beijing
  • University Hospital Augsburg — Augsburg
  • Charité - Universitätsmedizin — Berlin
  • St. Georg Hospital — Leipzig
  • University Hospital Mannheim — Mannheim
  • Technical University of Munich (TUM), Department of Radiation Oncology — Munich
  • Klinikum Stuttgart — Stuttgart
  • Helios University Hospital Wuppertal — Wuppertal
  • Gangnam Severance Hospital, Yonsei University College of Medicine — Seoul
  • Catalan Institute of Oncology (ICO) — Barcelona
  • Hospital Reina Sofia — Córdoba
  • The London Clinic — London

New York

  • Long Island Jewish Medical Center, North Shore University Hospital — Lake Success
  • Lenox Hill Hospital, Hofstra Northwell School of Medicine — New York

Arizona

  • Barrow Neurological Institute (SJHMC) — Phoenix

Illinois

  • Stritch School of Medicine Loyola University — Maywood

West Virginia

  • West Virginia University — Morgantown

Quebec

  • Montreal Neurological Institute and Hospital — Montreal

Trial Details

FieldValue
Enrollment Target 314 participants
Start Date 2016-12-09
Est. Completion 2026-06
Phase Phase 3

Sponsor

Universitätsmedizin Mannheim

1 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02685605

The ClinicalTrials.gov registry entry for NCT02685605 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Universitätsmedizin Mannheim, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions — of which Temozolomide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02685605 reports 19 study locations spanning 6 distinct geographic areas — top geographies include Other, New York, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02685605 about?

NCT02685605 is a clinical study titled "Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme". INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to s...

What is the current status of trial NCT02685605?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 314 participants. The study started on 2016-12-09. Estimated completion is 2026-06.

What conditions does trial NCT02685605 study?

This clinical trial studies the following conditions: Glioblastoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02685605?

The interventions under investigation include: Temozolomide (DRUG), Standard surgery (PROCEDURE), Intraoperative radiotherapy (RADIATION), Radiochemotherapy (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02685605?

This trial is sponsored by Universitätsmedizin Mannheim, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02685605 being conducted?

This trial has 19 study locations across Arizona, Illinois, New York, West Virginia, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial