Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01649830
Other study ID # 2012012
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 2012
Est. completion date August 2026

Study information

Verified date May 2020
Source Sun Yat-sen University
Contact Zhong-ping CHEN, MD, PhD
Phone +86-20-87343310
Email chenzhp@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Low-grade glioma (LGG) is a common primary brain tumor in young adults. The infiltrative nature and frequent growth in eloquent area in brain often makes total resection impossible. Until now, no agreement has been achieved on the treatment of LGG without total resection. Post-radiation adjuvant temozolomide (TMZ) is currently the standard of care for high-grade gliomas. Radiotherapy or TMZ is recommended for the treatment of residue low-grade gliomas. However, the efficacy of combined radiotherapy with adjuvant TMZ for residue LGG remains to be defined. In this randomized controlled trial, the investigators will test the hypothesis that radiotherapy with subsequent TMZ chemotherapy is superior to improve the progression-free survival of patients with residue LGG without significant impairment to quality of life compared to radiotherapy alone.


Recruitment information / eligibility

Status Recruiting
Enrollment 290
Est. completion date August 2026
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Age: 18 years to 60 years

- Incompletely resected supratentorial WHO II astrocytoma, oligodendroglioma or oligodendroastrocytoma

- Karnofsky Performance Score = 60

- Adequate bone marrow, liver and renal function

- Ability of subject to understand character and individual consequences of the clinical trial

- Written informed consent

Exclusion Criteria:

- Refusal to participate the study

- Known hypersensitivity or contraindication to temozolomide

- Previous irradiation, prior radiosurgery or prior chemotherapy

- Pregnant or lactating females

- Malignant tumor other than brain tumor

- Contraindicated for MRI examination

- Unable to comply with the follow-up studies of this trial

Study Design


Intervention

Radiation:
Radiotherapy
External beam radiation: 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.
Drug:
Temozolomide
dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days.

Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival 5 years
Secondary Quality of life 5 years
See also
  Status Clinical Trial Phase
Terminated NCT02764151 - First in Patient Study for PF-06840003 in Malignant Gliomas Phase 1
Completed NCT00994071 - A Phase I Study of ABT-888, an Oral Inhibitor of Poly(ADP-ribose) Polymerase and Temozolomide in Children With Recurrent/Refractory CNS Tumors Phase 1
Completed NCT02903784 - Neural Basis of Language Processing N/A
Terminated NCT01502605 - Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas Phase 1
Terminated NCT01044966 - A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma Phase 1/Phase 2
Completed NCT00705198 - Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062) N/A
Completed NCT00165360 - Prolonged Daily Temozolomide for Low-Grade Glioma Phase 2
Active, not recruiting NCT03911388 - HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors Phase 1
Terminated NCT00389090 - A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma Phase 2
Completed NCT00154375 - Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma Phase 3
Completed NCT00001148 - Detecting Malignant Brain Tumor Cells in the Bloodstream During Surgery to Remove the Tumor N/A
Completed NCT03722355 - Hyperfractionated RT With BCNU Versus Conventional RT With BCNU for Supratentorial Malignant Glioma Phase 3
Recruiting NCT03975829 - Pediatric Long-Term Follow-up and Rollover Study Phase 4
Recruiting NCT05686798 - Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma. Phase 1
Active, not recruiting NCT03739372 - Clinical Benefit of Using Molecular Profiling to Determine an Individualized Treatment Plan for Patients With High Grade Glioma N/A
Recruiting NCT05624736 - Hierarchical Diagnosis for Adult Diffuse Glioma Based on Deep Learning
Recruiting NCT05345002 - All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma Phase 2
Recruiting NCT04028479 - The Registry of Oncology Outcomes Associated With Testing and Treatment
Completed NCT00783393 - SCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma (Study P03745) Phase 2
Completed NCT03900689 - Social Determinants of Health in Glioblastoma Population