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

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ClinicalTrials.gov Identifier: NCT04316039
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
Xingchen Peng, West China Hospital

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.

Condition or disease Intervention/treatment Phase
Low-grade Glioma Drug: Temozolomide Radiation: intensity modulated radiation therapy Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : April 10, 2023
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RT+TMZ Drug: Temozolomide
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.

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

Active Comparator: RT Radiation: intensity modulated radiation therapy
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 Measures :
  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04316039


Contacts
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Contact: Xingchen Peng, Ph.D +86 18980606753 pxx2014@scu.edu.cn

Locations
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China, Sichuan
Xingchen Peng Recruiting
Chengdu, Sichuan, China, 610041
Contact: Xingchen Peng, Ph.D    +8618980606753    pxx2014@scu.edu.cn   
Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Xingchen Peng, Ph.D West China Hospital
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Responsible Party: Xingchen Peng, PhD, Associate Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT04316039    
Other Study ID Numbers: ChiCTR1800015199
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xingchen Peng, West China Hospital:
low-grade glioma
High-risk
Radiotherapy
Temozolomide
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents