Study of Temozolomide and Lomustine Followed by Radiotherapy versus Standard Treatment in Patients with Newly Diagnosed Grade 2 or 3 Glioma

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What is this study about?

This clinical trial focuses on patients with newly diagnosed grade 2 or 3 glioma, a type of brain tumor with specific genetic characteristics including 1p/19q co-deletion. The study aims to evaluate two different treatment approaches to improve patient outcomes.

The first treatment approach combines two chemotherapy drugs – temozolomide and lomustine – followed by radiation therapy to part of the brain and additional chemotherapy if the disease progresses. The second approach starts with radiation therapy followed by a combination of three chemotherapy drugs: procarbazine, lomustine, and vincristine (known as PCV chemotherapy), with additional treatment options if the disease progresses.

During the study, doctors will monitor how well patients function in their daily activities, their thinking abilities, and their quality of life. These factors, along with survival time, will help determine which treatment approach works better. The medications used in this study are given either by mouth as capsules or through an intravenous line directly into the bloodstream.

1 Initial assessment

Following surgery for grade 2 or 3 glioma (brain tumor), your participation can begin between 2 weeks and 3 months after the operation

Your surgical site must be properly healed before starting the treatment

A brain scan (MRI) will be performed within 72 hours after surgery

2 Treatment path A

Option 1: You will receive temozolomide and lomustine (CETEG) as oral medications

If the disease progresses, you will receive partial brain radiation therapy combined with PCV treatment (procarbazine, lomustine, and vincristine)

The vincristine will be administered through an intravenous line, while other medications will be taken orally

3 Treatment path B

Option 2: You will receive partial brain radiation therapy first

This will be followed by PCV treatment (procarbazine, lomustine, and vincristine)

If the disease progresses, your doctor will determine the best treatment option

4 Monitoring

Regular brain function tests will be conducted throughout the treatment

Quality of life assessments will be performed periodically

Physical functioning and communication abilities will be evaluated regularly

Brain scans will be performed to monitor the tumor

5 Study duration

The study continues from March 2021 to March 2031

Your participation duration will depend on your individual treatment response

Who Can Join the Study?

  • Must have a newly diagnosed WHO grade 2 or 3 glioma confirmed by tissue examination
  • Surgical site from brain biopsy or surgery must be properly healed
  • Must be between 2 weeks and 3 months after surgery without any radiation therapy, chemotherapy, or experimental treatment
  • Must be willing to participate in regular brain function tests and quality of life questionnaires
  • Must need post-surgical therapy
  • Must provide written consent to participate
  • Must be at least 18 years old
  • Must have a Karnofsky Performance score of 60% or higher (a measure of ability to perform daily activities)
  • Must have a life expectancy greater than 6 months
  • Must have tumor tissue samples available for research
  • Must have had an MRI scan within 72 hours after surgery
  • Tumor must have an IDH mutation (a specific genetic change in the tumor)
  • Tumor must have specific genetic changes called 1p/19q co-deletion
  • For women who can become pregnant:
    • Must have a negative pregnancy test within 6 days before starting treatment
    • Must use effective birth control during treatment and for 6 months after
    • Must not donate breast milk during this period
  • For men:
    • Must use effective birth control during treatment and for 6 months after
    • Must not donate sperm during this period

Who Cannot Join the Study?

  • Previous treatment with chemotherapy (drug treatment designed to kill cancer cells) for brain tumor
  • Previous radiation therapy (treatment using high-energy rays) to the brain
  • Presence of other types of cancer that require immediate treatment
  • Severe heart, liver, or kidney disease that could interfere with treatment
  • Pregnancy or breastfeeding
  • Unable to undergo MRI scanning (magnetic resonance imaging) due to metal implants or severe claustrophobia (fear of enclosed spaces)
  • History of seizures that are not well controlled with medication
  • Active infection requiring treatment
  • Known allergic reactions to similar chemotherapy drugs
  • Mental conditions that could prevent understanding of trial requirements
  • Inability to take oral medications
  • Participation in other clinical trials within the past 30 days
  • Blood test results outside of acceptable ranges for safe treatment
  • Life expectancy less than 12 weeks

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany
Universitaetsmedizin Goettingen Goettingen Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany

Other Sites

Site Name City Country Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Johannes Wesling Klinikum Minden Minden Germany
HELIOS Kliniken Schwerin GmbH Schwerin Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Saarland University Hospital Homburg Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Universitaetsklinikum Leipzig AöR Leipzig Germany
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Udnoyedngg Hqkzyhwt Culzlnh Cologne Germany
Gqxefy Uvyyisjowp Fcxgdgofd Frankfurt Germany
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
25.03.2021

Trial locations

Temozolomide
A chemotherapy medication used to treat brain tumors. It works by slowing or stopping the growth of cancer cells. It’s taken as oral medication and is part of the initial treatment combination in this trial.

Lomustine
A chemotherapy drug that can cross the blood-brain barrier to treat brain tumors. It belongs to a group of drugs called alkylating agents, which work by interfering with cancer cell DNA to stop their growth.

Procarbazine
An oral chemotherapy medication that is part of the PCV combination therapy. It works by interfering with cell growth and is commonly used in treating brain tumors.

Vincristine
A chemotherapy medication that is given through an IV (intravenous) infusion. It works by stopping cancer cells from dividing and growing. It’s part of the PCV combination treatment used in this trial.

Investigated diseases:

Glioma (WHO grade 2 and 3) – A brain tumor that develops from glial cells, which support and protect nerve cells in the brain. Grade 2 and 3 gliomas are moderately growing tumors that can infiltrate surrounding brain tissue. These tumors typically start in the cerebral hemispheres of the brain, affecting functions like movement, speech, or memory depending on their location. Over time, these tumors can expand and cause increased pressure within the brain, leading to various neurological symptoms. Grade 3 gliomas generally grow more quickly than grade 2 tumors and show more abnormal cell features under the microscope.

Note: The source data mentions only one disease condition, so I’ve provided a description for that specific condition.

Trial ID:
2024-510616-73-00
Protocol code:
NOA-18
NCT ID:
NCT05331521
Trial Phase:
Therapeutic confirmatory (Phase III)

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