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

NCT02520635 | Unknown DMC

• 1 other identifier: B0008
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Keywords

prognosis; supra-early chemotherapy

Outcome Measures

Primary Outcomes (1)

• progression free survival

  Up to 2 years

Secondary Outcomes (3)

• Overall Survival (OS)

  Up to 2 years

• Objective Response Rate

  Up to 2 years

• Treatment-related adverse event

  Up to 2 years

Study Arms (2)

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.

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.

Drug: supra-early TEMODAL® chemotherapy; Radiation: Radiotherapy 60Gy

Interventions

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with prior histological confirmation of newly diagnosed primary glioblastoma multiforme in supratentorial cerebral hemisphere.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Song Lin, MD

  Beijing Tiantan Hospital

  STUDY DIRECTOR

Central Study Contacts

Song Lin, MD

CONTACT

8601067096509; linsong2005@126.com

Chun Zeng, MD

CONTACT

8613520118570; zengchun79@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of neurosurgical supratentorial tumor ward

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: August 13, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 11, 2019

Record last verified: 2019-07

Locations

CN (1)