NCT01015534

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2006

Typical duration for phase_2

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

January 1, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

May 8, 2013

Completed
Last Updated

May 8, 2013

Status Verified

March 1, 2013

Enrollment Period

3.8 years

First QC Date

November 17, 2009

Results QC Date

August 23, 2012

Last Update Submit

March 25, 2013

Conditions

Brain Neoplasms

Keywords

Brain metastasesTemozolomideWhole-brain radiotherapyPhase II trial

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rates. Assessed With Cranial MRI

    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 Outcomes (3)

  • Survival Free of Brain Metastases Progression (PFS of BM)

    at 90 days

  • Overall Survival

    1 year

  • Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.

    4 months

Study Arms (2)

Whole brain irradiation plus Temozolomide

EXPERIMENTAL

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: TemozolomideRadiation: Whole brain irradiation

Whole brain irradiation

ACTIVE COMPARATOR

Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks

Radiation: Whole brain irradiation

Interventions

TemozolomideDRUG
Also known as: Temodar, or, Temodal
Whole brain irradiation plus Temozolomide
Whole brain irradiationRADIATION
Also known as: Whole brain radiotherapy
Whole brain irradiationWhole brain irradiation plus Temozolomide

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Cancerología de México

México, D.F, 14080, Mexico

Location

Related Publications (4)

  • Jones SF, Greco FA, Gian VG, Miranda FT, Raefsky EL, Hainsworth JD, Willcutt NT, Beschorner AF, Kennerly G, Burris HA 3rd. A Phase I trial of protracted oral fixed-dose temozolomide. Cancer. 2005 Nov 1;104(9):1985-91. doi: 10.1002/cncr.21408.

    PMID: 16134182BACKGROUND

  • Antonadou D, Paraskevaidis M, Sarris G, Coliarakis N, Economou I, Karageorgis P, Throuvalas N. Phase II randomized trial of temozolomide and concurrent radiotherapy in patients with brain metastases. J Clin Oncol. 2002 Sep 1;20(17):3644-50. doi: 10.1200/JCO.2002.04.140.

    PMID: 12202665BACKGROUND

  • Verger E, Gil M, Yaya R, Vinolas N, Villa S, Pujol T, Quinto L, Graus F. Temozolomide and concomitant whole brain radiotherapy in patients with brain metastases: a phase II randomized trial. Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):185-91. doi: 10.1016/j.ijrobp.2004.04.061.

    PMID: 15629610BACKGROUND

  • Gamboa-Vignolle C, Ferrari-Carballo T, Arrieta O, Mohar A. Whole-brain irradiation with concomitant daily fixed-dose temozolomide for brain metastases treatment: a randomised phase II trial. Radiother Oncol. 2012 Feb;102(2):187-91. doi: 10.1016/j.radonc.2011.12.004. Epub 2012 Jan 16.

    PMID: 22257825DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Our study had methodological limitations, such as the two temozolomide dose levels, which in future clinical trials may be adjusted to a single level.

Results Point of Contact

Title
Carlos Gamboa Vignolle/ Radiation Oncologist
Organization
Instituto Nacional de Cancerologia de Mexico
cswgamboa@yahoo.com
0155556280400

Study Officials

  • Carlos Gamboa-Vignolle, MD

    Instituto Nacional de Cancerología de México

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

January 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

May 8, 2013

Results First Posted

May 8, 2013

Record last verified: 2013-03

Locations

ME(1)