Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03633552 |
|
Recruitment Status : Unknown
Verified August 2018 by Seyed Alireza Javadinia, Mashhad University of Medical Sciences.
Recruitment status was: Recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
|
Sponsor:
Mashhad University of Medical Sciences
Information provided by (Responsible Party):
Seyed Alireza Javadinia, Mashhad University of Medical Sciences
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glioblastoma Multiforme of Brain Anaplastic Astrocytoma of Brain | Drug: Temozolomide | Phase 3 |
This study aimed to compare the overall survival and progression free survival between 6 cycles and 12 cycles adjuvant Temozolomide regimens in patients with brain glioblastoma and anaplastic astrocytoma. The main inclusion criterion includes patients newly diagnosed with glioblastoma and anaplastic astrocytoma whose diagnosis is confirmed by histologic evaluation. The main exclusion criteria involve chronic renal, hepatic or cardiac failure. The patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients will receive chemoradiation. After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body surface per day for the first 5 days of every 28 days). In the control group, the patients will receive 6 cycles of adjuvant Temozolomide (in the same dosage). This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1). This study will be conducted in the oncology clinic of Omid Hospital and Imam Reza Hospital, Mashhad. Blinding is not observed in this study. The primary endpoints of study are overall survival and progression free survival.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 62 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1). |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Single-blind, Randomized, Clinical Trial Comparing the Efficacy of 6 Cycles Versus 12 Cycles Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma |
| Actual Study Start Date : | March 3, 2018 |
| Estimated Primary Completion Date : | March 3, 2021 |
| Estimated Study Completion Date : | April 3, 2021 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Temozolomide
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 12-cycle arm
After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meters body surface per day for the first 5 days of every 28 days).
|
Drug: Temozolomide
The patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients will receive chemoradiation. After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body surface per day for the first 5 days of every 28 days). In the control group, the patients will receive 6 cycles of adjuvant Temozolomide (in the same dosage).
Other Name: Temodar, Temodal, Temcad, Glidar |
|
Active Comparator: 6-cycle arm
After completion of chemoradiation, the participants will receive 6 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meters body surface per day for the first 5 days of every 28 days).
|
Drug: Temozolomide
The patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients will receive chemoradiation. After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body surface per day for the first 5 days of every 28 days). In the control group, the patients will receive 6 cycles of adjuvant Temozolomide (in the same dosage).
Other Name: Temodar, Temodal, Temcad, Glidar |
Primary Outcome Measures :
- Overall survival [ Time Frame: up to 1 year from start of treatment ]The time interval between the diagnosis and death.
- Progression-free survival [ Time Frame: up to 1 year from start of treatment ]The time interval between the diagnosis and disease progression based on radiologic criteria or symptoms
Secondary Outcome Measures :
- Anemia [ Time Frame: monthly, up to 12 months during treatment ]blood hemoglobin lower than 10 grams per deciliter
- Neutropenia [ Time Frame: monthly, up to 12 months during treatment ]Blood almost mature neutrophils count lower than 1500/mm3
- Presence of alopecia [ Time Frame: monthly, up to 12 months during treatment ]A condition in which hair is lost
- Presence of nausea [ Time Frame: monthly, up to 12 months during treatment ]An unpleasant sense of unease, discomfort, and revulsion towards food
- Presence of vomiting [ Time Frame: monthly, up to 12 months during treatment ]Eject matter from the stomach through the mouth.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Newly diagnosed glioblastoma and anaplastic astrocytoma
- age between 18 and 70 years
- Karnofsky Performance Scale Index equal or more than 60 percent
- signed informed consent
Exclusion Criteria:
- chronic hepatic
- renal failure
- cardiac failure
- history of hematologic malignancies
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633552
Contacts
| Contact: Seyed Alireza Javadinia, M.D. | 00989155728157 | Javadiniaa941@mums.ac.ir | |
| Contact: Mohammadreza Saghafi, M.D. | 00989127898938 | SaghafiMR951@mums.ac.ir |
Locations
| Iran, Islamic Republic of | |
| Radiation ward of Emam Reza Hospital | Recruiting |
| Mashhad, Razavi Khorasan, Iran, Islamic Republic of, 9137913316 | |
| Contact: Roham Salek, M.D. +985138426936 SalekR@mums.ac.ir | |
| Principal Investigator: Kazem Anvari, M.D. | |
| Omid Hospital | Recruiting |
| Mashhad, Razavi Khorasan, Iran, Islamic Republic of, 917661377 | |
| Contact: Seyed Amir Aledavood, M.D. +985138426936 AledavoodA@mums.ac.ir | |
| Principal Investigator: Kazem Anvari, M.D. | |
| Principal Investigator: Mahdi Silanian Toosi, M.D. | |
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
| Study Director: | Mahdi Silanian Toosi, M.D. | Mashhad University of Medical Sciences | |
| Study Chair: | Kazem Anvari, M.D. | Mashhad University of Medical Sciences |
| Responsible Party: | Seyed Alireza Javadinia, Principal Investigator, Mashhad University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT03633552 |
| Other Study ID Numbers: |
960021 IRCT20160706028815N3 ( Registry Identifier: Iranian Registry of Clinical Trials ) |
| First Posted: | August 16, 2018 Key Record Dates |
| Last Update Posted: | August 16, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | It is not yet known if there will be a plan to make this available. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Keywords provided by Seyed Alireza Javadinia, Mashhad University of Medical Sciences:
|
Glioblastoma Multiforme Anaplastic Astrocytoma Adjuvant treatment Extended chemotherapy |
Additional relevant MeSH terms:
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |