NCT00033254

Brief Summary

Randomized phase III trial to compare the effectiveness of radiation therapy with or without thalidomide in treating patients who have brain metastases. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as thalidomide may stop the growth of brain metastases by stopping blood flow to the tumor. It is not yet known whether radiation therapy is more effective with or without thalidomide in treating brain metastases.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
332

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2002

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

4.2 years

First QC Date

April 9, 2002

Last Update Submit

October 29, 2020

Conditions

Tumors Metastatic to Brain

Outcome Measures

Primary Outcomes (3)

  • Overall survival

    The log-rank statistic will be used.

    Up to 6 years

  • Time to tumor progression

    Cumulative incidence model will be used to analyze the data. A multivariate Cox model analysis will be performed.

    Date of randomization to documentation of progression, assessed up to 6 years

  • Time to neuro-cognitive progression as assessed by the Mini Mental State Exam

    Cumulative incidence model will be used to analyze the data.

    Up to 6 years

Secondary Outcomes (4)

  • Cause of death distribution

    Up to 6 years

  • Frequency of toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0

    Up to 6 years

  • Quality of life as measured by the Spitzer Quality of Life Index (SQLI)

    6 months

  • Quality of life as measured by the SQLI

    12 months

Study Arms (2)

Arm I (radiation therapy)

ACTIVE COMPARATOR

Patients undergo radiotherapy once daily 5 days a week for 3 weeks.

Radiation: radiation therapyProcedure: quality-of-life assessment

Arm II (radiation therapy, thalidomide)

EXPERIMENTAL

Patients undergo radiotherapy as in arm I. Beginning on the first day of radiotherapy, patients receive oral thalidomide once daily.

Radiation: radiation therapyDrug: thalidomideProcedure: quality-of-life assessment

Interventions

radiation therapyRADIATION

Undergo conventional radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation
Arm I (radiation therapy)Arm II (radiation therapy, thalidomide)
thalidomideDRUG

Given orally

Also known as: Kevadon, Synovir, THAL, Thalomid
Arm II (radiation therapy, thalidomide)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Arm I (radiation therapy)Arm II (radiation therapy, thalidomide)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed extracranial primary malignancy
  • Multiple brain metastases
  • At least 1 measurable brain metastasis by MRI
  • More than 4.0 cm
  • Located in midbrain or brainstem (radiosurgery ineligible)
  • Performance status - Zubrod 0-1
  • At least 8 weeks
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 11 g/dL\*
  • Hematocrit at least 35%\*
  • Bilirubin no greater than 1.5 mg/dL
  • ALT no greater than 2 times normal
  • Creatinine no greater than 1.5 mg/dL
  • BUN no greater than 25 mg/dL
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiation Therapy Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

RadiotherapyRadiationThalidomide

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical PhenomenaPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jonathan Knisely

    Radiation Therapy Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2002

First Posted

January 27, 2003

Study Start

March 1, 2002

Primary Completion

May 1, 2006

Last Updated

October 30, 2020

Record last verified: 2020-10

Locations

US(1)