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Supra-early Post-Surgery Chemotherapy in the Treatment on GBM Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients with prior histological confirmation of newly diagnosed primary glioblastoma multiforme in supratentorial cerebral hemisphere. 2. Gross total resection or partial resection (imaging) >70%. 3. Chemo-radiotherapy to be expected from Week 5 (Day 29) after surgery. 4. Age >=18 and <=70 years. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 6. Life expectancy >=9 months. 7. Laboratory test values must satisfy the following criteria: 1. absolute neutrophil count >=1.5 x 10^9/L; 2. platelet count >=100 x 10^9/L; 3. hemoglobin >=80 g/L; 4. blood urea nitrogen and creatinine < 1.5 x upper limit of normal value (ULN); 5. total bilirubin and direct bilirubin < 1.5 x ULN; 6. alanine aminotransferase and aspartate aminotransferase < 3 x ULN; 7. alkaline phosphatase < 2 x ULN. 8. Patients must be willing to provide written informed consent. 9. Patients of child-bearing potential (including female subjects and the female partners of male subjects) must use an effective method of contraception.

Exclusion Criteria:

1. Patients without prior histological confirmation of primary glioblastoma multiforme. 2. Patient with previous or current malignancies at other sites. 3. Patient who received chemotherapy, radiotherapy for study indication, or other medications for antitumor indication prior to surgery. 4. Patient with recurrent or multiple malignant glioma (including gliomatosis cerebri). 5. Patient with metastatic lesions at the subtentorial or outside of calvaria. 6. Patient who received chemotherapy or radiotherapy sensitizers for head or neck tumor. 7. Patient who received radiotherapy at head or neck which leads to radiotherapy domain overlapping. 8. Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction). 9. Known human immunodeficiency virus (HIV)-positive or acquired immune deficiency syndrome (AIDS)-related illness. 10. Woman who is pregnant or breastfeeding. 11. Patient with a history of hypersensitivity to temozolomide or other analogic alkylating agents. 12. Patient with severe myelosuppression. 13. 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02520635
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Beijing Tiantan Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Song Lin, MD
Principal Investigator Affiliation Beijing Tiantan Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

: 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.

: 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.

Interventions

Drug: - supra-early TEMODAL® chemotherapy

Drug: - standard TEMODAL® chemotherapy

Radiation: - Radiotherapy 60Gy

Contact a Trial Team

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International Sites

Beijing Tiantan Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Beijing Tiantan Hospital

Beijing, Beijing, 100005