UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022502 |
|---|---|
| Receipt number | R000025939 |
| Scientific Title | Prospective study of intensity-modulated radiation therapy using standard radiation dose for high-grade glioma |
| Date of disclosure of the study information | 2016/05/27 |
| Last modified on | 2023/07/03 13:18:16 |
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Basic information
Public title
Prospective study of intensity-modulated radiation therapy using standard radiation dose for high-grade glioma
Acronym
IMRT using standard radiation dose for HGG
Scientific Title
Prospective study of intensity-modulated radiation therapy using standard radiation dose for high-grade glioma
Scientific Title:Acronym
IMRT using standard radiation dose for HGG
Region
| Japan |
Condition
Condition
High-grade glioma
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the treatment outcomes of IMRT using standard radiation dose (60 Gy in 30 fractions) in patients with high-grade glioma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression-free survival, Completion rate of IMRT, Grade 3 or more non-hematological toxicity evaluated every 12 months
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The prescribed dose of IMRT is 60 Gy in 30 fractions over 6 weeks (2 Gy per fraction, five fractions per week). The chemotherapy regimens are not regulated.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically proven high-grade glioma
2. No tumor recognized in the brainstem and optic nerve on preoperative MRI
3. Planning target volume (irradiated 60Gy) is less than 1/3 of the brain volume
4. Aged 20 to 75 years old
5. ECOG performance status of 0,1 or 3 due to neurological signs caused by the tumor
6. Written informed consent
Key exclusion criteria
1. No prior radiation therapy for intracranial disease
2. Prior treatment for high-grade glioma
3. Women during pregnancy, possible pregnancy, or breast-feeding, patient who wish pregnancy
4. Psychiatric disease
5. Inappropriate patients for this study judged by physicians
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Shibata |
Organization
Kagawa University Hospital
Division name
Department of Radiation Oncology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-898-5111
shibata.toru@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigeo |
| Middle name | |
| Last name | Takahashi |
Organization
Kagawa University Hospital
Division name
Department of Radiation Oncology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-898-5111
Homepage URL
takahashi.shigeo@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagawa University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Neurosurgery, Kagawa University, Faculty of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Kagawa University Faculty of Medicine
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
Tel
087-898-5111
kenkyushien@kagawa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
香川大学医学部附属病院（香川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
https://www.cancerdiagnosisprognosis.org/storage/cdp/3/4/cdp-3-491.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.cancerdiagnosisprognosis.org/storage/cdp/3/4/cdp-3-491.pdf
Number of participants that the trial has enrolled
20
Results
The completion rate of IMRT was 100%. The median follow-up period was 29 months (range=6-68 months). Median OS and PFS were 30 and 14 months, respectively. No patients experienced Grade 3 or higher non-hematological toxicity. The 2-year OS rates were 100%, 57%, and 33% in Radiation Therapy Oncology Group-Recursive Partitioning Analysis (RTOG-RPA) classes I/II, IV, and V, respectively (p=0.002; log-rank test).
Results date posted
| 2023 | Year | 07 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Between 2016 and 2019, 20 patients were enrolled. According to the World Health Organization 2016 Classification, glioblastoma, anaplastic astrocytoma, and anaplastic oligodendroglioma were present in nine, six, and five of the recruited patients, respectively. Gross total resection, partial resection, and biopsy were performed in four, nine, and seven patients, respectively. All patients received concurrent and adjuvant chemotherapy using temozolomide with or without bevacizumab.
Participant flow
This prospective, single-institution and single-arm trial (clinical trial registration number: UMIN000022502) was approved by our institutional ethics committee (approval number: H28-008). Patients with written informed consent were registered before postoperative IMRT.
Inclusion criteria were as follows: patients who 1) had histologically proven HGG, 2) had no tumor in the brainstem and optic nerve on preoperative magnetic resonance imaging (MRI), 3) had a planning target volume (PTV) for 60 Gy less than 1/3 of the brain volume, 4) were aged 20-75 years old, 5) had Eastern Cooperative Oncology Group performance statuses of 0-2, or 3 due to neurological signs caused by their tumors, and 6) provided written informed consent. Histology was diagnosed based on the World Health Organization (WHO) 2016 classification.
Exclusion criteria were as follows: patients who 1) had undergone prior RT for intracranial diseases, 2) had received prior treatment for HGG, 3) were women who were pregnant, possibly pregnant, or breast-feeding, 4) were women who wished to become pregnant during the treatment course, 5) had psychiatric diseases, and 6) were unsuitable for this study, as judged by physicians.
Adverse events
No patients experienced Grade 3 or higher non-hematological toxicity.
Outcome measures
The completion rate of IMRT was 100%. The median follow-up period was 29 months (range=6-68 months). Median OS and PFS were 30 and 14 months, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 27 | Day |
Last modified on
| 2023 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025939
