GlioblastomaNCT02520635
Supra-early Post-Surgery Chemotherapy in the Treatment on GBM Patients
An observational study of Glioblastoma, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The primary purpose of the study is to evaluate the efficacy and safety of supra-early post-surgery chemotherapy versus standard TEMODAL® regimen in treatment of patients with newly diagnosed glioblastoma multiforme. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- supra-early TEMODAL® chemotherapy, standard TEMODAL® chemotherapy and Radiotherapy 60Gy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with prior histological confirmation of newly diagnosed primary glioblastoma multiforme in supratentorial cerebral hemisphere.
Who may be able to join
- Patients with prior histological confirmation of newly diagnosed primary glioblastoma multiforme in supratentorial cerebral hemisphere.
- Gross total resection or partial resection (imaging) >70%.
- 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.
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- 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 without prior histological confirmation of primary glioblastoma multiforme.
- Patient with previous or current malignancies at other sites.
- 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.
- 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 severe myelosuppression
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100005
About this study
Official title: A Clinical Study of Supra-early Post-Surgery Chemotherapy Plus Standard TEMODAL® Regimen Versus Standard TEMODAL® Regimen in the Treatment on Patients With Newly Diagnosed Glioblastoma Multiforme
The primary purpose of the study is to evaluate the efficacy and safety of supra-early post-surgery chemotherapy versus standard TEMODAL® regimen in treatment of patients with newly diagnosed glioblastoma multiforme. The secondary purpose is to assess the efficacy of supra-early post-surgery chemotherapy in release brain edema.
Read the detailed description
Glioblastoma (GBM) is the most common primary malignant brain tumor. Despite great efforts have been devoted to promoting the treatment effect, GBM remains one of the most lethal tumors concurrent with poor prognosis and inevitable recurrence. The standard treatment protocol for GBM includes surgical resection, radiotherapy and temozolomide (TMZ) based chemotherapy. TMZ, an alkylating agent, has been proved to be efficient to control tumor growth after surgery and gradually has been recognized in routine clinical course for GBM. In a pivotal clinical trial published in 2005, GBM patients received concomitant TMZ and radiotherapy followed by 6 periods of adjuvant TMZ chemotherapy had a median survival of 14.6 months and 5-year survival rate of 9.8%, which has been regarded as a landscape in treatment history of GBM. To date, this regimen remains the standard protocol for newly diagnosed GBM patients. However, the optimal timing of initiation of TMZ or radiotherapy remains unclear. Our previous study showed 75mg per square meter of body surface per day (mg/m2/d) of TMZ chemotherapy alone was effective to control post-operative edema caused by tumor cell infiltration in primary GBM patients. The result suggested anti-cancer agents such as TMZ may be a useful regimen to control tumor cell regrowth after operation. Therefore, we conducted this prospective clinical trial to testify the hypothesis that supra-early initiation of TMZ chemotherapy in newly diagnosed GBM patients is effective to control tumor growth after tumor resection and therefore improve patients'clinical outcome.
- Conditions
- Glioblastoma
- Being tested
- supra-early TEMODAL® chemotherapy, standard TEMODAL® chemotherapy, Radiotherapy 60Gy
- Keywords
- prognosis, supra-early chemotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supra-early TEMODAL® chemotherapyDrug
standard TEMODAL® chemotherapyDrug
Radiotherapy 60GyRadiation
| Study group | Role | What they receive |
|---|---|---|
| TEMODAL® standard therapy regimen | 4 weeks after surgery, patients are administered with radiotherapy that consisted of fractionated focal irradiation at a dose of 2 Gy per fraction given once daily 5 dyas a week over a period of 6 weeks. Concomitant TEMODAL® are administered orally at a daily dose of 75mg/m2 from the first day of radiotherapy until the last day of radiotherapy, but for no longer than 49 days. After a 4-week break, patients were then to receive up to 6 cycles of adjuvant TEMODAL® chemotherapy according to the standard 5-day schedule every 28 days.The dose is 150mg/m2 once daily for cycle 1 and is increase to 200mg/m2 at the beginning of cycle 2, so long as there were no hematologic toxic effects. Receives: Drug: standard TEMODAL® chemotherapy; Radiation: Radiotherapy 60Gy | |
| post-surgery supra-early TEMODAL® chemotherapy | Within 24 hours after surgery, Supra-early TEMODAL® Chemotherapy is administered orally at 75mg/m2/day for 28 days for patients pathologically confirmed as GBM. 4 weeks after surgery, patients are administered with radiotherapy that consisted of fractionated focal irradiation at a dose of 2 Gy per fraction given once daily 5 dyas a week over a period of 6 weeks. Concomitant TEMODAL® are administered orally at a daily dose of 75mg/m2 from the first day of radiotherapy until the last day of radiotherapy, but for no longer than 49 days. After a 4-week break, patients were then to receive up to 6 cycles of adjuvant TEMODAL® chemotherapy according to the standard 5-day schedule every 28 days.The dose is 150mg/m2 once daily for cycle 1 and is increase to 200mg/m2 at the beginning of cycle 2, so long as there were no hematologic toxic effects. Receives: Drug: supra-early TEMODAL® chemotherapy; Radiation: Radiotherapy 60Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: Up to 2 years
Secondary outcomes (3)
Overall Survival (OS)
Measured: Up to 2 years
Objective Response Rate
Measured: Up to 2 years
Treatment-related adverse event
Number of participants with adverse events
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.
- First posted13 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Lin, Beijing Tiantan Hospital
- Investigators
- Song Lin, MD, Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520635
- Sponsor's protocol ID
- B0008
- Status last verified
- Jul 2019
- First submitted
- 26 Jun 2015
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Supra-early Post-Surgery Chemotherapy Plus Standard TEMODAL® Regimen Versus Standard TEMODAL® Regimen in the Treatment on Patients With Newly Diagnosed Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT02520635
- Acronym / sponsor ID
- B0008
- Conditions
- Glioblastoma
- Keywords
- prognosis, supra-early chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to evaluate the efficacy and safety of supra-early post-surgery chemotherapy versus standard TEMODAL® regimen in treatment of patients with newly diagnosed glioblastoma multiforme. The secondary purpose is to assess the efficacy of supra-early post-surgery chemotherapy in release brain edema.
Detailed description
Glioblastoma (GBM) is the most common primary malignant brain tumor. Despite great efforts have been devoted to promoting the treatment effect, GBM remains one of the most lethal tumors concurrent with poor prognosis and inevitable recurrence. The standard treatment protocol for GBM includes surgical resection, radiotherapy and temozolomide (TMZ) based chemotherapy. TMZ, an alkylating agent, has been proved to be efficient to control tumor growth after surgery and gradually has been recognized in routine clinical course for GBM. In a pivotal clinical trial published in 2005, GBM patients received concomitant TMZ and radiotherapy followed by 6 periods of adjuvant TMZ chemotherapy had a median survival of 14.6 months and 5-year survival rate of 9.8%, which has been regarded as a landscape in treatment history of GBM. To date, this regimen remains the standard protocol for newly diagnosed GBM patients. However, the optimal timing of initiation of TMZ or radiotherapy remains unclear. Our previous study showed 75mg per square meter of body surface per day (mg/m2/d) of TMZ chemotherapy alone was effective to control post-operative edema caused by tumor cell infiltration in primary GBM patients. The result suggested anti-cancer agents such as TMZ may be a useful regimen to control tumor cell regrowth after operation. Therefore, we conducted this prospective clinical trial to testify the hypothesis that supra-early initiation of TMZ chemotherapy in newly diagnosed GBM patients is effective to control tumor growth after tumor resection and therefore improve patients'clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEMODAL® standard therapy regimen | – | Drug: standard TEMODAL® chemotherapy, Radiation: Radiotherapy 60Gy4 weeks after surgery, patients are administered with radiotherapy that consisted of fractionated focal irradiation at a dose of 2 Gy per fraction given once daily 5 dyas a week over a period of 6 weeks. Concomitant TEMODAL® are administered orally at a daily dose of 75mg/m2 from the first day of radiotherapy until the last day of radiotherapy, but for no longer than 49 days. After a 4-week break, patients were then to receive up to 6 cycles of adjuvant TEMODAL® chemotherapy according to the standard 5-day schedule every 28 days.The dose is 150mg/m2 once daily for cycle 1 and is increase to 200mg/m2 at the beginning of cycle 2, so long as there were no hematologic toxic effects. |
| post-surgery supra-early TEMODAL® chemotherapy | – | Drug: supra-early TEMODAL® chemotherapy, Radiation: Radiotherapy 60GyWithin 24 hours after surgery, Supra-early TEMODAL® Chemotherapy is administered orally at 75mg/m2/day for 28 days for patients pathologically confirmed as GBM. 4 weeks after surgery, patients are administered with radiotherapy that consisted of fractionated focal irradiation at a dose of 2 Gy per fraction given once daily 5 dyas a week over a period of 6 weeks. Concomitant TEMODAL® are administered orally at a daily dose of 75mg/m2 from the first day of radiotherapy until the last day of radiotherapy, but for no longer than 49 days. After a 4-week break, patients were then to receive up to 6 cycles of adjuvant TEMODAL® chemotherapy according to the standard 5-day schedule every 28 days.The dose is 150mg/m2 once daily for cycle 1 and is increase to 200mg/m2 at the beginning of cycle 2, so long as there were no hematologic toxic effects. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with prior histological confirmation of newly diagnosed primary glioblastoma multiforme in supratentorial cerebral hemisphere.
Key inclusion criteria (16 listed)
- Patients with prior histological confirmation of newly diagnosed primary glioblastoma multiforme in supratentorial cerebral hemisphere.
- Gross total resection or partial resection (imaging) >70%.
- 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.
Key exclusion criteria (13 listed)
- Patients without prior histological confirmation of primary glioblastoma multiforme.
- Patient with previous or current malignancies at other sites.
- 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.
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 |
|---|---|---|
| supra-early TEMODAL® chemotherapy | Drug | post-surgery supra-early TEMODAL® chemotherapy |
| standard TEMODAL® chemotherapy | Drug | TEMODAL® standard therapy regimen |
| Radiotherapy 60Gy | Radiation | TEMODAL® standard therapy regimen, post-surgery supra-early TEMODAL® chemotherapy |
Primary outcome
progression free survival
Time frame: Up to 2 years
3 secondary outcomes
Overall Survival (OS)
Time frame: Up to 2 years
Objective Response Rate
Time frame: Up to 2 years
Treatment-related adverse event
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
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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.
Song Lin, MD study director
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by Beijing Tiantan Hospital at 1 site in China.
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 16 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: status not confirmed, as of the sponsor's last update on 11 Jul 2019. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Song Lin, MD (8601067096509, linsong2005@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (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?
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 11 Jul 2019.