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Actively Recruiting

Phase 3
Age: 18Years - 60Years
All Genders
ID01649830

Study of Radiotherapy With or Without Temozolomide Chemotherapy in Adults Aged 18 to 60 With Residual Low-grade Brain Tumors

Led by Sun Yat-sen University · Updated on 2020-05-28

290

Participants Needed

1

Research Sites

52 weeks

Total Duration

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

Research Team

Z

Zhong-ping CHEN, MD, PhD

K

Ke SAI, MD, PhD

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