Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment

March 25, 2013 updated by: Carlos Gamboa Vignolle, Instituto Nacional de Cancerologia de Mexico

Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment

RATIONALE

  • Fractionated radiotherapy uses high-energy photons to kill, or damage tumor cells. High daily dose temozolomide combined with fractionated radiotherapy may make tumor cells more sensible to treatment.

PURPOSE

  • This randomized phase II trial, assess in patients with brain metastases from solid tumors, whether the whole brain radiotherapy (WBRT) plus temozolomide is able to improve the results obtained with WBRT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Outcome Measures

  • Objective Response Rates

Secondary Outcome Measures

  • Survival Free of Brain Metastases progression
  • Overall Survival
  • Systemic Side effects

Objectives

Primary

  • Compare objective response rates in both arms of treatment

Secondary

  • Compare survival free of progression in both arms of treatment
  • Compare Overall Survival in both arms of treatment
  • Compare side effects

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • D.F
      • México, D.F, Mexico, 14080
        • Instituto Nacional De Cancerologia de Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Karnofsky performance status (KPS) ≥ 50
  • Life expectancy ≥ 12 weeks
  • Histologically confirmed non lymphomatous solid tumors at primary site
  • Brain metastases diagnosed with cranial MRI/CT.
  • Extracranial metastases or primary tumor uncontrolled are allowed
  • Hemoglobin ≥ 10 g/dl
  • Absolute neutrophil count of > 1500/mm3
  • Platelet count of ≥ 100,000/mm3
  • Blood urea nitrogen (BUN) ≤ 25 mg/dl,
  • Serum creatinin ≤ 1.5 mg/dl
  • Serum bilirubins ≤ 1.5 mg/dl,
  • Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ twice the upper normal limit

Exclusion Criteria

  • Pregnant or breast feeding woman
  • History of allergic reaction to iodinated contrast media
  • Inability to swallow
  • Systemic chemotherapy in previous 3 weeks
  • Oral chemotherapy in previous 2 weeks
  • Prior surgery, chemotherapy, or radiotherapy for a brain neoplasm
  • Meningeal carcinomatosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole brain irradiation plus Temozolomide
Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
Drug: Temozolomide
Other Names:
  • Temodar
  • Temodal
  • or
Radiation: Whole brain irradiation
Other Names:
  • Whole brain radiotherapy
Active Comparator: Whole brain irradiation
Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks
Radiation: Whole brain irradiation
Other Names:
  • Whole brain radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rates. Assessed With Cranial MRI
Time Frame: 90 days

Objective Response (OR) encompassed the number of participants with Complete Response (CR) and the number of participants with Partial Response (PR). CR is the disappearance of all brain metastases, assessed between two or more cranial MRI. PR is at least a 30% decrease in the sum of the longest diameter of the brain metastases, taking as reference the baseline sum longest diameter, assessed between two or more cranial MRI.

Objective Response Rate (ORR) is the ratio between the number of participants with objective response and the total number of participants.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Free of Brain Metastases Progression (PFS of BM)
Time Frame: at 90 days
Progression free survival of brain metastases is the survival of participants without progressive brain metastases or without neurological symptoms. The progressive brain metastases (PBM) were evaluated with cranial MRI. The PBM were defined as an increase of at least 20% in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new metastases.
at 90 days
Overall Survival
Time Frame: 1 year
Overall survival:Time in months measured from treatment initiation until the date of death or the date of last follow-up.
1 year
Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.
Time Frame: 4 months

AE, evaluated and graded according to the NCI common terminology criteria (NCI-CTCAE) v3.0

Grade 3 Severe AE.

Grade 4 Life-threatening or disabling AE.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia de Mexico

Investigators

  • Principal Investigator: Carlos Gamboa-Vignolle, MD, Instituto Nacional De Cancerologia de Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

November 17, 2009

First Posted (Estimate)

November 18, 2009

Study Record Updates

Last Update Posted (Estimate)

May 8, 2013

Last Update Submitted That Met QC Criteria

March 25, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 006/004/TEI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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