Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 70Years
All Genders
NCT04316039

Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery

Led by West China Hospital · Updated on 2020-03-20

250

Participants Needed

1

Research Sites

559 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Interval between surgery and randomization is less than 12 weeks
  • Have signed the consent form
Not Eligible

You will not qualify if you...

  • WHO grade I gliomas or high-grade gliomas according to WHO's grading system
  • Prior radiation therapy to the head and neck region
  • Prior chemotherapy
  • Synchronous multiple primary malignant tumors excluding carcinoma of the cervix in situ or nonmelanomatous skin cancer
  • Prior malignancy's disease-free survival less than 5 years
  • Active infection
  • Pregnant or breast-feeding patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Xingchen Peng

Chengdu, Sichuan, China, 610041

Actively Recruiting

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Research Team

X

Xingchen Peng, Ph.D

CONTACT

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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