NCT04316039 Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
| NCT ID | NCT04316039 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | West China Hospital |
| Condition | Low-grade Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2018-04-10 |
| Primary Completion | 2023-04-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 250 participants in total. It began in 2018-04-10 with a primary completion date of 2023-04-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 patients, though large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide can improve PFS and OS in patients with high-risk low-grade gliomas.
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 interval between surgery and randomization is less than 12 weeks; 6. Have signed the consent form. - Exclusion Criteria: 1. WHO grade I gliomas or high-grade gliomas according to WHO's grading system; 2. Have received prior radiation therapy to the head and neck region; 3. Have received prior chemotherapy; 4. Synchronous multiple primary malignant tumor excluding carcinoma of the cervix in situ or nonmelanomatous skin cancer; 5. Prior malignancy's disease-free survival less than 5 years; 6. Have active infection; 7. Patients are pregnant or breast-feeding. -
Contact & Investigator
Xingchen Peng, Ph.D
PRINCIPAL INVESTIGATOR
West China Hospital
Frequently Asked Questions
Who can join the NCT04316039 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Low-grade Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04316039 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04316039 currently recruiting?
Yes, NCT04316039 is actively recruiting participants. Contact the research team at pxx2014@scu.edu.cn for enrollment information.
Where is the NCT04316039 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT04316039 clinical trial?
NCT04316039 is sponsored by West China Hospital. The principal investigator is Xingchen Peng, Ph.D at West China Hospital. The trial plans to enroll 250 participants.