Actively Recruiting
Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residual Low-grade Glioma
Led by Sun Yat-sen University · Updated on 2020-05-28
290
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Low-grade glioma (LGG) is a common brain tumor in young adults that often cannot be fully removed due to its location and growth pattern. This trial evaluates whether adding chemotherapy with temozolomide after standard radiotherapy improves progression-free survival without harming quality of life for patients with residual LGG. The study is a phase 3 randomized controlled trial sponsored by Sun Yat-sen University. Participants will receive radiotherapy within 8 weeks after neurosurgery, with a total dose of 54.0 Gy given over 6 to 7 weeks in 27 to 30 fractions. One group will then receive six cycles of temozolomide chemotherapy starting four weeks after radiotherapy, with dosing given daily for 5 days every 28 days. The other group will receive radiotherapy alone without temozolomide. Throughout the trial, participants will be monitored for progression-free survival and quality of life over five years. Evaluations include clinical assessments and follow-up visits to track disease status and any effects on well-being. The study investigates whether combined treatment improves outcomes compared to radiotherapy alone over the long term.
CONDITIONS
Brief Title
Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years
- Incompletely resected supratentorial WHO II astrocytoma, oligodendroglioma, or oligodendroastrocytoma
- Karnofsky Performance Score of 60 or higher
- Adequate bone marrow, liver, and renal function
- Ability to understand the clinical trial and provide written informed consent
You will not qualify if you...
- Refusal to participate in the study
- Known allergy or contraindication to temozolomide
- Previous radiation, radiosurgery, or chemotherapy treatment
- Pregnant or breastfeeding women
- Having a malignant tumor other than brain tumor
- Contraindication for MRI examination
- Unable to comply with follow-up requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 7 weeks
Participants receive external beam radiation totaling 54.0 Gy in 27 to 30 fractions over 6 to 7 weeks to treat residual low-grade glioma.
Daily visits for radiation sessions over 6 to 7 weeks
Duration - 6 cycles of 28 days each
Participants in the experimental arm receive adjuvant temozolomide chemotherapy dosed daily for 5 consecutive days every 28 days, starting 4 weeks after radiotherapy, for 6 cycles.
1 visit per cycle (in-person), total of 6 visits
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Z
Zhong-ping CHEN, MD, PhD
K
Ke SAI, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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