Gateway-study

Phase 2

• Conditions: ewly Diagnosed glioblastoma; glioblastoma

• Registration Number: JPRN-jRCTs051180159
• Lead Sponsor: Kijima Noriyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Stage1
1) To have MRI within 14 days before treatment
2) Suspicion of GBM (grade 4) or detection of malignant gliomas by the pathological diagnosis during surgery or detection of malignant gliomas by the pathological diagnosis during surgery and diagnosis GBM by MRI before implant gliadel
3) Using 5-ALA when the tumor removed
4) To provide tissue sample
5) 20 to 75 years old
6) ECOG performance status of 0 or 1
7) Sufficient function of important organs. And required baseline within 4 weeks before treatment
Neu >= 1,500mm3
Plt >=75,000mm3
Hb >= 8g/dL
AST and ALT <= 3 x baseline that depends on hospital
Serum Bil <= 1.5 x max value that depends on hospital
Alb >= 3.0g/dL
Cr <= 1.5mg/dL
ECG: no abnormal condition
Pulmonary function: SpO2 >= 94%
8) No uncontrollable pleural, peritoneal or cardiac effusion
9) Expect survival time is 3-month and more
10) Written informed consent either before or after surgery(within a 14 day period)

Stage2
1) Take MRI scan within 14 days before implant gliadel
2) Recurrent GBM
3) The best treatment that remove tumor when the GBM recurrent
4) Using 5-ALA when the tumor removed
5) To provide tissue sample
6) Sufficient function of important organs. And required baseline within 4 weeks before treatment
Neu >= 1,500mm3
Plt >=75,000mm3
Hb >= 8g/dL
AST and ALT <= 3 x baseline that depends on hospital
Serum Bil <= 1.5 x max value that depends on hospital
Alb >= 3.0g/dL
Cr <= 1.5mg/dL
ECG: no abnormal condition
Pulmonary function: SpO2 >= 94%
7) No uncontrollable pleural, peritoneal or cardiac effusion
8) Expect survival time is 3-month and more

Exclusion Criteria

Stage1
1) Multiple tumor or tumor that over median line
2) Serum positive for HBs antigen
3) High risk of fatality due to systemic disease within 12 months
4) Falling under any of the following
(1)Patients have had a tumor removed for purposes other than this study(excluding patients who have had biopsies for pathological evaluation)
(2) Chemotherapy before remove tumor
(3) Radiation therapy for brain
5) Treat interstitial therapy or Stereotactic Radiosurgery (SRS)
6) Impossible contrast-enhanced MRI
7) Hypersensitivity to Nitrosourea
8) Treated Malignancy or complication Malignancy except brain
9) Used gliadel or carmustine
10) Impossible join this study because of complications that over Grade3 provided by JCOG
11) Need intravenous transfusion, tube feeding or TPN within 24 hours because of alimentary canal issue and so on
12) Pregnant or nursing females
13) Serious mental disability
14) Other reasons for exclusion

Stage2
1) High risk of fatality due to systemic disease within 6 months
2) Serum positive for HBs antigen
3) Impossible contrast-enhanced MRI
4) Treated Malignancy or complication Malignancy except brain
5) Impossible join this study because of complications that over Grade3 provided by JCOG
6) Need intravenous transfusion, tube feeding or TPN within 24 hours because of alimentary canal issue and so on
7) Pregnant or nursing females
8) Serious mental disability
9) Other reasons for exclusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stage1:Progression Free Survival percentage for 12 months <br>Stgae2:Overall Survival, rate of AE

Secondary Outcome Measures

Name	Time	Method
Stage1:Overall Survival, rate of AE