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

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ClinicalTrials.gov Identifier: NCT01015534
Recruitment Status : Completed
First Posted : November 18, 2009
Results First Posted : May 8, 2013
Last Update Posted : May 8, 2013
Sponsor:
Information provided by (Responsible Party):
Carlos Gamboa Vignolle, Instituto Nacional de Cancerologia de Mexico

Tracking Information
First Submitted Date  ICMJE November 17, 2009
First Posted Date  ICMJE November 18, 2009
Results First Submitted Date  ICMJE August 23, 2012
Results First Posted Date  ICMJE May 8, 2013
Last Update Posted Date May 8, 2013
Study Start Date  ICMJE January 2006
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2009)
Objective Response Rates. Assessed with IRM/CT Scan [ Time Frame: at 90 days ]
Change History Complete list of historical versions of study NCT01015534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2013)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2009)
  • Survival Free of Brain Metastases progression [ Time Frame: at 90 days ]
  • Overall Survival [ Time Frame: 1 year ]
  • Side effects [ Time Frame: 4 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment
Official Title  ICMJE Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment
Brief Summary

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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain Neoplasms
Intervention  ICMJE
  • Drug: Temozolomide
    Other Names:
    • Temodar
    • or
    • Temodal
  • Radiation: Whole brain irradiation
    Other Name: Whole brain radiotherapy
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Temozolomide
    • Radiation: Whole brain irradiation
  • Active Comparator: Whole brain irradiation
    Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks
    Intervention: Radiation: Whole brain irradiation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2009)
55
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01015534
Other Study ID Numbers  ICMJE 006/004/TEI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carlos Gamboa Vignolle, Instituto Nacional de Cancerologia de Mexico
Study Sponsor  ICMJE Instituto Nacional de Cancerologia de Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carlos Gamboa-Vignolle, MD Instituto Nacional de Cancerología de México
PRS Account Instituto Nacional de Cancerologia de Mexico
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP