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NCT Number: NCT04316039

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

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.

Recruiting

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Key information

Conditions

Low-grade Glioma

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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. -

Exclusion criteria

  • 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. -

Treatment and study plan

Temozolomide

Drug

Concurrent chemotherapy is to receive oral temozolomide, 75 mg/m2 per day, during radiation therapy. Adjuvant chemotherapy will be treated with six cycles of temozolomide, 150 to 200 mg/m2 per day for five consecutive days, repeated every 4 weeks. There is a 28-day break during radiotherapy and adjuvant temozolomide.

Intensity modulated radiation therapy

Radiation

The radiation dose is 50-54 Gy given in 25-30 fractions (1.8-2.0 Gy once daily, 5 days per week).

Primary outcomes

  1. Progression-free survival

    Time frame: up to 120 months

    Our primary outcome is progression-free survival which is calculated from the date of randomization to the date of first reported disease progression or the date of death.

Study contacts

Contact information is provided by the study sponsor or research team.

Xingchen Peng, Ph.D

CONTACT

[email protected]

+86 18980606753

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2028
First posted
Mar 20, 2020
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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