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

NCT ID: NCT00686725

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-24
• Study Completion Date: 2011-09-28

Brief 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.

Conditions

Glioblastoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Temozolomide + Radiation

Standard 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.

Group Type: ACTIVE_COMPARATOR

Temozolomide

Intervention Type: DRUG

Radiotherapy

Intervention Type: RADIATION

Temozolomide alone, then Temozolomide + Radiation

Early 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.

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

Radiotherapy

Intervention Type: RADIATION

Interventions

Temozolomide

Intervention Type: DRUG

Radiotherapy

Intervention Type: RADIATION

Other Intervention Names

Temodal; Temodar; SCH 052365; Irradiation; radiation therapy

Eligibility Criteria

Inclusion Criteria

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.
• 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.

Exclusion Criteria

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

PMID: 26481741 (View on PubMed)

Other Identifiers

P05572

Identifier Type: -

Identifier Source: org_study_id