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

Primary Purpose

Low-grade Glioma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Temozolomide
intensity modulated radiation therapy
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low-grade Glioma focused on measuring low-grade glioma, High-risk, Radiotherapy, Temozolomide

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Newly diagnosed supratentorial WHO grade II gliomas;
  2. Aged 18 to 39 years without total resection, or aged 40 to 70 years with any extent of resection or biopsy;
  3. Karnofsky performance score (KPS) ≥ 60;
  4. No more than moderate neurologic symptoms and signs;
  5. The interval between surgery and randomization is less than 12 weeks;
  6. Have signed the consent form. -

Exclusion Criteria:

  1. WHO grade I gliomas or high-grade gliomas according to WHO's grading system;
  2. Have received prior radiation therapy to the head and neck region;
  3. Have received prior chemotherapy;
  4. Synchronous multiple primary malignant tumor excluding carcinoma of the cervix in situ or nonmelanomatous skin cancer;
  5. Prior malignancy's disease-free survival less than 5 years;
  6. Have active infection;
  7. Patients are pregnant or breast-feeding. -

Sites / Locations

  • Xingchen PengRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RT+TMZ

RT

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 17, 2020
Last Updated
March 19, 2020
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04316039
Brief Title
Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
Official Title
Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
April 10, 2023 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-grade Glioma
Keywords
low-grade glioma, High-risk, Radiotherapy, Temozolomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RT+TMZ
Arm Type
Experimental
Arm Title
RT
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
intensity modulated radiation therapy
Intervention Description
The radiation dose is 50-54 Gy given in 25-30 fractions (1.8-2.0 Gy once daily, 5 days per week).
Primary Outcome Measure Information:
Title
Progression-free survival
Description
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.
Time Frame
up to 120 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xingchen Peng, Ph.D
Phone
+86 18980606753
Email
pxx2014@scu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xingchen Peng, Ph.D
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xingchen Peng
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingchen Peng, Ph.D
Phone
+8618980606753
Email
pxx2014@scu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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