Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02520635
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Song Lin, Beijing Tiantan Hospital

Tracking Information
First Submitted Date June 26, 2015
First Posted Date August 13, 2015
Last Update Posted Date July 11, 2019
Actual Study Start Date January 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 9, 2015)
progression free survival [ Time Frame: Up to 2 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02520635 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 9, 2015)
  • 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 ]
    Number of participants with adverse events
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Supra-early Post-Surgery Chemotherapy in the Treatment on GBM Patients
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
Brief 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. 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with prior histological confirmation of newly diagnosed primary glioblastoma multiforme in supratentorial cerebral hemisphere.
Condition Glioblastoma
Intervention
  • Drug: supra-early TEMODAL® chemotherapy
  • Drug: standard TEMODAL® chemotherapy
  • Radiation: Radiotherapy 60Gy
Study Groups/Cohorts
  • 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.
    Interventions:
    • 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.
    Interventions:
    • Drug: supra-early TEMODAL® chemotherapy
    • Radiation: Radiotherapy 60Gy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 9, 2019)
180
Original Estimated Enrollment
 (submitted: August 9, 2015)
100
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Song Lin, MD 8601067096509 linsong2005@126.com
Contact: Chun Zeng, MD 8613520118570 zengchun79@aliyun.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02520635
Other Study ID Numbers B0008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Song Lin, Beijing Tiantan Hospital
Study Sponsor Beijing Tiantan Hospital
Collaborators Not Provided
Investigators
Study Director: Song Lin, MD Beijing Tiantan Hospital
PRS Account Beijing Tiantan Hospital
Verification Date July 2019