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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

18 criteria

  • 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 trial?

14 criteria

  • 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
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Investigated drugs

  • 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.

What is already known about the treatment

  • Temozolomide

    An oral chemotherapy medication used in the treatment of brain tumors, particularly gliomas. This drug works by damaging the DNA of cancer cells, preventing them from dividing and growing. It belongs to the alkylating agents class of chemotherapy drugs and is typically administered in capsule form as part of a combined treatment approach.

  • Lomustine

    A chemotherapy medication taken orally that belongs to the nitrosoureas class of drugs, commonly used in treating brain tumors and Hodgkin's lymphoma. It works by interfering with cancer cell DNA, stopping or slowing their growth. The medication is usually given as a single dose every six weeks as part of a treatment regimen.

  • Procarbazine

    An oral chemotherapy drug used in combination therapy for brain tumors and Hodgkin's lymphoma. It belongs to the alkylating agents class and works by interfering with DNA synthesis in cancer cells, preventing their multiplication. The medication is typically administered as part of the PCV (Procarbazine, CCNU, and Vincristine) combination therapy protocol.

  • Vincristine

    An intravenous chemotherapy medication belonging to the vinca alkaloids class, commonly used in combination treatments for various cancers including brain tumors. It works by blocking cell division and preventing cancer cells from multiplying. The drug is administered through injection as part of combination chemotherapy regimens like PCV.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510616-73-00Protocol codeNOA-18Estimated enrolment406 patientsSponsorUniversitaetsklinikum Heidelberg AöR

sourced from the EU Clinical Trials Register and site verification

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