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

Primary Purpose

Glioma, Glioblastoma Multiforme, Astrocytoma

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Conventional RT

Hyperfractionated RT

Carmustine

About this trial

This is an interventional treatment trial for Glioma focused on measuring Glioma, Glioblastoma, Glioblastoma multiforme, Astrocytoma

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1: Conventional RT + Carmustine

Arm 2: Hyperfractionated RT + Carmustine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Full Information

NCT ID

NCT03722355

First Posted

October 23, 2018

Last Updated

November 7, 2019

Sponsor

Radiation Therapy Oncology Group

1. Study Identification

Unique Protocol Identification Number

NCT03722355

Brief Title

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

Official Title

A Phase III Comparison of Hyperfractionated Radiation Therapy (RT) With BCNU and Conventional RT With BCNU for Supratentorial Malignant Glioma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

November 9, 1990 (Actual)

Primary Completion Date

March 15, 1994 (Actual)

Study Completion Date

October 18, 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radiation Therapy Oncology Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioma, Glioblastoma Multiforme, Astrocytoma

Keywords

Glioma, Glioblastoma, Glioblastoma multiforme, Astrocytoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

712 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Conventional RT + Carmustine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm 2: Hyperfractionated RT + Carmustine

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Conventional RT

Intervention Description

Radiation therapy

Intervention Type

Radiation

Intervention Name(s)

Hyperfractionated RT

Intervention Description

Radiation therapy

Intervention Type

Drug

Intervention Name(s)

Carmustine

Other Intervention Name(s)

BCNU, Gliadel

Intervention Description

Chemotherapy

Primary Outcome Measure Information:

Title

Overall Survival

Description

Overall Survival

Time Frame

From randomization to the date of death or last follow up, assessed up to 131 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Walter J Curran, Jr., MD

Organizational Affiliation

Radiation Therapy Oncology Group

Official's Role

Principal Investigator

12. IPD Sharing Statement

Links:

URL

https://nctn-data-archive.nci.nih.gov/

Description

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Learn more about this trial

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

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