Radiotherapy Plus Temozolomide for Low-grade Gliomas
Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
Recruiting
Phase 2
Phase 3
Interventional Study
Low-grade Glioma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 250 (estimated)
- Sponsor
- West China Hospital · Other
Who this trial is looking for
This trial is looking for patients with a certain type of brain tumor called low-grade gliomas. Participants will receive radiotherapy along with a medication named temozolomide after their surgery.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with a high-risk low-grade glioma
- I am between 18 and 39 years old without complete tumor removal
- I am between 40 and 70 years old with any extent of resection or biopsy
- My Karnofsky performance score is 60 or higher
- I have no more than moderate neurological symptoms
- It has been less than 12 weeks since my surgery
- I have signed the consent form
You may not be able to join if
- I have a high-grade glioma or a WHO grade I glioma
- I have had radiation therapy to my head or neck before
- I have received chemotherapy before
- I have multiple primary cancers, except for certain skin cancers
- My previous cancer treatment was less than 5 years ago
- I have an active infection
- I am pregnant or breastfeeding
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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Answer a few quick questions to see if you may meet the eligibility requirements.
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About This Trial
It has been reported that radiation therapy followed by PCV chemotherapy (procarbazine, lomustine and vincristine) could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk WHO grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide to treat these…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Newly diagnosed supratentorial WHO grade II gliomas;
2. Aged 18 to 39 years without total resection, or aged 40 to 70 years with any extent of resection or biopsy;
3. Karnofsky performance score (KPS) ≥ 60;
4. No more than moderate neurologic symptoms and signs;
5. The interv…
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