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GlioblastomaPhase 4NCT00686725

Standard Temodal (Temozolomide) Regimen Versus Standard Regimen Plus Early Postsurgery Temodal for Newly Diagnosed Glioblastoma Multiforme (Study P05572)

A Phase 4 study testing Temozolomide and Radiotherapy in people with Glioblastoma, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma multiforme. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Glioblastoma
What is being tested?
Temozolomide and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
No sites listed yet
Study dates
24 Jun 2008to 28 Sep 2011
Phase
Phase 4
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Only the patients who meet all these criteria can be enrolled in the study:
  • Patients with prior histological confirmation of newly diagnosed primary glioblastoma multiforme in supratentorial cerebral hemisphere.
  • Gross total resection or partial resection (imaging) >70%.
  • At least be capable to obtain a tissue sample for MGMT analysis during surgery.
  • Chemo-radiotherapy to be expected from Week 5 (Day 29) after surgery.
  • Age >=18 and <=70 years.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Life expectancy >=9 months.
  • Laboratory test values must satisfy the following criteria:
  • absolute neutrophil count >=1.5 x 10^9/L;
  • platelet count >=100 x 10^9/L;
  • hemoglobin >=80 g/L;
  • blood urea nitrogen and creatinine < 1.5 x upper limit of normal value (ULN);
  • total bilirubin and direct bilirubin < 1.5 x ULN;
  • alanine aminotransferase and aspartate aminotransferase < 3 x ULN;
  • alkaline phosphatase < 2 x ULN.
  • Patients must be willing to provide written informed consent.
  • Patients of child-bearing potential (including female subjects and the female partners of male subjects) must use an effective method of contraception.

Who cannot join

  • Patients will not be enrolled if any of the following criteria apply:
  • Patient with previous or current malignancies (except melanoma) at other sites, unless disease free for at least 3 years.
  • Patient who received chemotherapy, radiotherapy for study indication, or other medications for antitumor indication prior to surgery.
  • Patient with recurrent or multiple malignant glioma (including gliomatosis cerebri).
  • Patient with metastatic lesions at the subtentorial or outside of calvaria.
  • Patient who received chemotherapy or radiotherapy sensitizers for head or neck tumor.
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  • Patient who received radiotherapy at head or neck which leads to radiotherapy domain overlapping.
  • Patient with acute infections requiring intravenous antibiotics.
  • Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
  • Known human immunodeficiency virus (HIV)-positive or acquired immune deficiency syndrome (AIDS)-related illness.
  • Woman who is pregnant or breastfeeding.
  • Patient with a history of hypersensitivity to temozolomide or other analogic alkylating agents.
  • Patient with any other conditions under which investigators think the subject is not suitable for enrolment, such like having known that the subject may not have good compliance.

About this study

Official title: A Clinical Study of Standard TEMODAL® Regimen Versus Standard Regimen Plus Early Post-Surgery TEMODAL® Chemotherapy in Treatment on Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)

The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma multiforme.

Conditions
Glioblastoma
Being tested
Temozolomide, Radiotherapy
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TemozolomideDrug

    Also called Temodal, Temodar, SCH 052365

  • RadiotherapyRadiation

    Also called Irradiation, radiation therapy

Study groups in NCT00686725
Study groupRoleWhat they receive
Temozolomide + RadiationActive comparatorStandard therapy regimen: Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used. Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
Receives: Drug: Temozolomide; Radiation: Radiotherapy
Temozolomide alone, then Temozolomide + RadiationExperimentalEarly postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
Receives: Drug: Temozolomide; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS was defined as the time from randomization to death.

    OS was calculated by the Kaplan-Meier method.

    Measured: Up to 2 years

Secondary outcomes (8)

  1. Progression-Free Survival (PFS)

    PFS was defined as the length of time from randomization to disease progression (the length of time during which the cancer did not get worse) or death.

    PFS was calculated by the Kaplan-Meier method.

    Measured: Up to 2 years

  2. Objective Tumor Assessment After Surgery: Overall Response

    Overall response was based on neuroimaging (magnetic resonance imaging [MRI]), clinical neurological examination, and steroid administration.

    It was assessed as follows:

    Complete Response (CR): Disappearance of all enhancing tumor (measurable

    or non-measurable), no corticosteroid use, and neurologically stable or

    improved.

    Partial Response (PR): ≥50% reduction in size of enhancing tumor

    (measurable or non-measurable) for any measurable lesions or definite

    improvement for any non-measurable lesions, corticosteroid dosage stable or

    reduced, and neurologically stable or improved.

    Progressive Disease (PD): ≥25% increase in contrast enhancement for any

    measurable lesions or definite worsening for any non-measurable lesions, or

    any new tumor on MRI scans, at an increased dose of corticosteroid, with or without neurologic progression. Clinical or radiological worsening resulting from other than tumor factors were excluded.

    Stable Disease (SD): All other situations.

    Measured: Up to 2 years

  3. Relationship Between O6-methylguanine-DNA Methyltransferase (MGMT) Status and Therapy Response: Overall Survival for the MGMT Positive Group

    MGMT was measured by immunohistochemistry (IHC).

    OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive.

    OS was calculated by the Kaplan-Meier method.

    Measured: Up to 2 years

  4. Relationship Between MGMT Status and Therapy Response: Overall Survival for the MGMT Negative Group

    MGMT was measured by IHC.

    OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive.

    OS was calculated by the Kaplan-Meier method.

    Measured: Up to 2 years

  5. Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Positive Group

    MGMT was measured by IHC.

    OS rate was defined as the percentage of participants who were still alive 6, 12, \& 18 months after starting study treatment.

    OS was calculated by the Kaplan-Meier method.

    Measured: 6, 12, & 18 months

  6. Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Negative Group

    MGMT was measured by IHC.

    OS rate was defined as the percentage of participants who were still alive 6, 12, \& 18 months after starting study treatment.

    OS was calculated by the Kaplan-Meier method.

    Measured: 6, 12, & 18 months

  7. Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Positive Group

    MGMT was measured by IHC.

    PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse.

    PFS was calculated by the Kaplan-Meier method.

    Measured: Up to 2 years

  8. Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Negative Group

    MGMT was measured by IHC.

    PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse.

    PFS was calculated by the Kaplan-Meier method.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2008 (estimated)
  2. Study start24 Jun 2008
  3. Primary completion28 Sep 2011
  4. Study completion28 Sep 2011

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00686725
Sponsor's protocol ID
P05572
Status last verified
May 2017
First submitted
27 May 2008
Last updated
14 Jun 2017
Data monitoring committee
No
Individual data sharing
Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

  • Mao Y, Yao Y, Zhang LW, Lu YC, Chen ZP, Zhang JM, Qi ST, You C, Wang RZ, Yang SY, Zhang X, Wang JS, Chen JX, Yang QY, Shen H, Li ZY, Wang X, Ma WB, Yang XJ, Zhen HN, Zhou LF. Does Early Postsurgical Temozolomide Plus Concomitant Radiochemotherapy Regimen Have Any Benefit in Newly-diagnosed Glioblastoma Patients? A Multi-center, Randomized, Parallel, Open-label, Phase II Clinical Trial. Chin Med J (Engl). 2015 Oct 20;128(20):2751-8. doi: 10.4103/0366-6999.167313.

    PubMed 26481741

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Temozolomide and Radiotherapy in people with Glioblastoma, run by Merck Sharp & Dohme LLC.

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 18 inclusion and 13 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 4 Apr 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?

Overall Survival (OS) (time frame: Up to 2 years). 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 NCT00686725, which also lists 1 linked publication.

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 14 Jun 2017.

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