Radiotherapy Versus Radiotherapy Combined With Temozolomi... | NCT04316039

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

NCT04316039

Sponsor

West China Hospital

Status

Recruiting

Last Update Posted

Mar 20, 2020Actual

Enrollment

250Estimated

Phase

Phase 2Phase 3

Conditions

Low-grade Glioma

Interventions

Temozolomide
intensity modulated radiation therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 10, 2018Actual

Primary Completion Date

Apr 10, 2023Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Mar 17, 2020

First Submission Date that Met QC Criteria

Mar 19, 2020

First Posted Date

Mar 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2020

Last Update Posted Date

Mar 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RT+TMZ	Experimental		Drug: Temozolomide Radiation: intensity modulated radiation therapy
RT	Active Comparator		Radiation: intensity modulated radiation therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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. -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xingchen Peng, Ph.D	Contact	+86 18980606753		pxx2014@scu.edu.cn

Overall Officials

Name	Affiliation	Role
Xingchen Peng, Ph.D	West China Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xingchen Peng	Recruiting	Chengdu	Sichuan	610041	China

Intervention Browse Module

MeSH Terms

ID	Term
D000077204	Temozolomide
D050397	Radiotherapy, Intensity-Modulated

Ancestor Terms

ID	Term
D003606	Dacarbazine
D014226	Triazenes
D009930	Organic Chemicals
D007093	Imidazoles

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