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Compares treatment options for Low-grade Glioma
Official title Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
ClinicalTrials.gov ID: NCT04316039
What this study is testing
What is Temozolomide?
Temozolomide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for low-grade glioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Newly diagnosed supratentorial WHO grade II gliomas;
- Aged 18 to 39 years without total resection, or aged 40 to 70 years with any extent of resection or biopsy;
- Karnofsky performance score (KPS) ≥ 60;
- No more than moderate neurologic symptoms and signs;
- The interval between surgery and randomization is less than 12 weeks;
You likely can't join if
- WHO grade I gliomas or high-grade gliomas according to WHO's grading system;
- Have received prior radiation therapy to the head and neck region;
- Have received prior chemotherapy;
- Synchronous multiple primary malignant tumor excluding carcinoma of the cervix in situ or nonmelanomatous skin cancer;
- Prior malignancy's disease-free survival less than 5 years;
- Have active infection;
See the full eligibility criteria
- Newly diagnosed supratentorial WHO grade II gliomas;
- Aged 18 to 39 years without total resection, or aged 40 to 70 years with any extent of resection or biopsy;
- Karnofsky performance score (KPS) ≥ 60;
- No more than moderate neurologic symptoms and signs;
- The interval between surgery and randomization is less than 12 weeks;
- Have signed the consent form. -
- WHO grade I gliomas or high-grade gliomas according to WHO's grading system;
- Have received prior radiation therapy to the head and neck region;
- Have received prior chemotherapy;
- Synchronous multiple primary malignant tumor excluding carcinoma of the cervix in situ or nonmelanomatous skin cancer;
- Prior malignancy's disease-free survival less than 5 years;
- Have active infection;
- Patients are pregnant or breast-feeding. -
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.