Hyperfractionated RT With BCNU Versus Conventional RT Wit... | NCT03722355

Studies
Hyperfractionated RT With BCNU Versus Conventional RT With BCNU for Supratentorial Malignant Glioma

NCT03722355

Sponsor

Radiation Therapy Oncology Group

Status

Completed

Last Update Posted

Nov 12, 2019Actual

Enrollment

712Actual

Phase

Phase 3

Conditions

Glioma
Glioblastoma Multiforme
Astrocytoma

Interventions

Conventional RT
Hyperfractionated RT
Carmustine

Countries

Not provided

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

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 9, 1990Actual

Primary Completion Date

Mar 15, 1994Actual

Completion Date

Oct 18, 2002Actual

First Submitted Date

Oct 23, 2018

First Submission Date that Met QC Criteria

Oct 24, 2018

First Posted Date

Oct 26, 2018Actual

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

Nov 7, 2019

Last Update Posted Date

Nov 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Hyperfractionated radiation therapy (RT) to 72.0 Gy with BCNU will be compared to conventional radiation therapy to 60.0 Gy with BCNU to determine if hyperfractionated RT can improve the median survival time of adults with supratentorial malignant 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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

712Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: Conventional RT + Carmustine	Active Comparator	Conventional RT: 60.0 Gy/30 fractions/2.0 Gy once daily + carmustine 80 mg/m2 IV on Days 1, 2, 3 of RT then every 8 weeks for 6 cycles	Radiation: Conventional RT Drug: Carmustine
Arm 2: Hyperfractionated RT + Carmustine	Experimental	Hyperfractionated RT: 72.0 Gy/60 fractions/6 weeks/1.2 Gy BID + carmustine 80 mg/m2 IV on Days 1, 2, 3 of RT and then every 8 weeks for 6 cycles	Radiation: Hyperfractionated RT Drug: Carmustine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conventional RT	Radiation	Radiation therapy	Arm 1: Conventional RT + Carmustine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival	Overall Survival	From randomization to the date of death or last follow up, assessed up to 131 months.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histopathologically confirmed glioblastoma multiforme (with areas of necrosis), malignant astrocytoma and astrocytoma with foci of anaplasia
Karnofsky Performance Score ≥ 60
Absolute Neutrophil count ≥ 1,500
Platelets ≥ 100,000
BUN ≤ 25
Creatinine ≤ 1.5
Bilirubin ≤ 2.0
Hemoglobin ≥ 10 gm
SGOT < 2 x upper limit of normal
SGPT < 2 x upper limit of normal

Exclusion Criteria:

No prior radiation to the head or neck area, chemotherapy or radiosensitizer
No malignancy with the past five years except non-melanomatous skin cancer or carcinoma in-situ of the cervix

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Walter J Curran, Jr., MD	Radiation Therapy Oncology Group	Principal Investigator

Locations

Not provided

References Module

Citations

Not provided

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

ID	Term
D002330	Carmustine
C574855	carmustine, poliferprosan 20 drug combination

ID	Term
D009607	Nitrosourea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals

ID	Term
D005910	Glioma
D005909	Glioblastoma
D001254	Astrocytoma