Brain NeoplasmsPhase 2NCT01015534
Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment
A Phase 2 study testing Temozolomide and Whole brain irradiation in people with Brain Neoplasms, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- Temozolomide and Whole brain irradiation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2006to Oct 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Brain Neoplasms
- Being tested
- Temozolomide, Whole brain irradiation
- Keywords
- Brain metastases, Temozolomide, Whole-brain radiotherapy, Phase II trial
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodar, or, Temodal
Whole brain irradiationRadiation
Also called Whole brain radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Temozolomide; Radiation: Whole brain irradiation |
| Whole brain irradiation | Active comparator | Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks Receives: Radiation: Whole brain irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (3)
Survival Free of Brain Metastases Progression (PFS of BM)
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.
Measured: at 90 days
Overall Survival
Overall survival:Time in months measured from treatment initiation until the date of death or the date of last follow-up.
Measured: 1 year
Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startJan 2006
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Gamboa Vignolle, Instituto Nacional de Cancerologia de Mexico
- Investigators
- Carlos Gamboa-Vignolle, MD, Principal investigator, Instituto Nacional de Cancerología de México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015534
- Sponsor's protocol ID
- 006/004/TEI
- Status last verified
- Mar 2013
- First submitted
- 17 Nov 2009
- Last updated
- 8 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 16134182Antonadou 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.
PubMed 12202665Verger 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.
PubMed 15629610Gamboa-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.
PubMed 22257825
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment
- ClinicalTrials.gov ID
- NCT01015534
- Acronym / sponsor ID
- 006/004/TEI
- Conditions
- Brain Neoplasms
- Keywords
- Brain metastases, Temozolomide, Whole-brain radiotherapy, Phase II trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 18 Nov 2009 (estimated)
- Results
- Posted 8 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole brain irradiation plus Temozolomide | Experimental | Drug: Temozolomide, Radiation: Whole brain irradiationWhole 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. |
| Whole brain irradiation | Active comparator | Radiation: Whole brain irradiationWhole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemozolomideAlso: Temodar, or, Temodal | Drug | Whole brain irradiation plus Temozolomide |
| Whole brain irradiationAlso: Whole brain radiotherapy | Radiation | Whole brain irradiation, Whole brain irradiation plus Temozolomide |
Primary outcome
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.
3 secondary outcomes
Survival Free of Brain Metastases Progression (PFS of BM)
Time frame: at 90 days
Overall Survival
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16134182Jones 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.
- Background: PubMed 12202665Antonadou 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.
- Background: PubMed 15629610Verger 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.
- Derived from this study: PubMed 22257825Gamboa-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Gamboa-Vignolle, MD principal investigator
Instituto Nacional de Cancerología de México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temozolomide and Whole brain irradiation in people with Brain Neoplasms, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rates. Assessed With Cranial MRI (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01015534, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2013.