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

NCT04316039 | Recruiting Phase 2

• 1 other identifier: ChiCTR1800015199
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Low-grade Glioma

Keywords

low-grade glioma; High-risk; Radiotherapy; Temozolomide

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  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.

  up to 120 months

Study Arms (2)

RT+TMZ

EXPERIMENTAL

Drug: Temozolomide; Radiation: intensity modulated radiation therapy

RT

ACTIVE COMPARATOR

Radiation: intensity modulated radiation therapy

Interventions

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.

RT+TMZ

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).

RT; RT+TMZ

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Xingchen Peng

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Interventions

Temozolomide; Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Xingchen Peng, Ph.D

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingchen Peng, Ph.D

CONTACT

+86 18980606753; pxx2014@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Associate Professor

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 20, 2020
• Study Start: April 10, 2018
• Primary Completion: April 10, 2023
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 20, 2020

Record last verified: 2020-03

Locations

CN (1)