GlioblastomaNCT06740955
Hypofractionated Radiotherapy
A study testing hypofractionated postoperative radiotherapy and Conventionally fractionated postoperative radiotherapy in people with Glioblastoma, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This study was a multicenter, open-label, randomized, controlled, phase Ⅲ clinical trial to evaluate the efficacy and safety of hypofractionated concurrent radiotherapy followed by sequential temozolomide after surgery in patients with newly diagnosed glioblastoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- hypofractionated postoperative radiotherapy and Conventionally fractionated postoperative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2024to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed glioblastoma confirmed by histopathology or molecular pathology;
- Complete or partial tumor resection or biopsy via neurosurgery;
- The age of signing the informed consent form was 18-70 years old, male or female; (4) KPS score ≥60; (5) expected survival time ≥6 months;
- 6. Radiotherapy should be started within 6 weeks after surgery; 7. Vital organ function meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days) : Normal bone marrow reserve: white blood cell (WBC) ≥3.0×109/L, neutrophil count (NEUT) ≥1.5×109/L, platelet count (PLT) ≥80×109/L, hemoglobin (Hb) ≥90 g/L Normal renal function or serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥50 ml/ minute (Cockcroft-Gault equation) Normal liver function or total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 times the upper limit of normal (ULN); 8. Able and willing to follow the study and follow-up procedures; 9. Men and women of childbearing potential must agree to use adequate contraception throughout the study and for 6 months after the end of treatment. Female subjects of childbearing potential were required to have a negative blood pregnancy test within 72 hours before the first dose.
- 10. The subjects voluntarily participated in this clinical study and signed the informed consent form. The compliance was good and the subjects could cooperate with the follow-up.
Who cannot join
- Received any previous systemic antitumor therapy against the target lesion;
- Prior radiation therapy to the head;
- Had a history of low-grade glioma and the current tumor transitioned to glioblastoma;
- The patient had glioma in other parts in the past, and now had metastasis, and the metastatic site was glioblastoma.
- Subjects were unable to undergo MRI examination or unable to undergo enhanced MRI examination.
- Patients who received bevacizumab or iodine internal radiation within one month before enrollment;
Show all 17Show fewer
- Participants who participated in other clinical trials within 1 month before enrollment;
- Subjects with severe trauma or severe infection within 1 month before enrollment, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc.
- Severe cardiovascular disease: grade Ⅱ or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmia (QTc interval ≥ 450 ms in men and ≥ 470 ms in women); Patients with grade ⅲ-ⅳ cardiac dysfunction (according to the New York Heart Association NYHA classification, see Appendix 3) or left ventricular ejection fraction (LVEF) less than 50% on echocardiography;
- Subjects underwent major surgery (excluding glioma surgery) within 4 weeks before enrollment;
- The subjects had a history of psychotropic drug abuse or drug use;
- Patients with other malignant tumors within 5 years before enrollment (if cured) were excluded;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA≥500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the detection limit of the analytical method) or co-infection with hepatitis B and C;
- Subjects were allergic to temozolomide or could not receive temozolomide treatment for other reasons;
- The results of blood pregnancy test of female subjects during non-lactation period and within 7 days before the first study treatment were positive. The subject (male or female) declined to commit to using at least one acceptable contraceptive method (i.e., using an intrauterine device (IUD), condom, any form of hormonal contraceptive, or abstinence, etc.) for the entire duration of the study and for 3 months after the last study treatment;
- Other conditions that increase the risk associated with participating in the study or the study drug and, in the investigator's judgment, may make the subject ineligible for the study;
- The investigator determined that he was not fit to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Weiyan Shi, PhD, 13944152797, drwyshi@163.com
About this study
Official title: A Randomized, Open, Controlled, Multi-center Clinical Trial of Hypofractionated Postoperative Radiotherapy for Adult Glioblastoma
This study was a multicenter, open-label, randomized, controlled, phase Ⅲ clinical trial to evaluate the efficacy and safety of hypofractionated concurrent radiotherapy followed by sequential temozolomide after surgery in patients with newly diagnosed glioblastoma.
A total of 420 subjects were enrolled in this study, randomized 1:1. According to the changes in overall survival time after postoperative concurrent chemoradiotherapy with different radiation doses, the stratification factors included the extent of surgical resection (total resection vs subtotal resection); The time of postoperative concurrent chemoradiotherapy (less than 28 days or more than 28 days); MGMT promoter methylation expression (positive or negative).
Read more
The study design was as follows: Participants were required to undergo a screening period within 14 days before randomization to determine eligibility. Subjects who met the inclusion criteria were randomly divided into two groups at a 1:1 ratio: trial group, hypofractionated concurrent chemoradiotherapy followed by at least 6 cycles of adjuvant temozolomide; The control group was treated with the existing standardized treatment (standard dose of concurrent chemoradiotherapy and at least 6 cycles of temozolomide adjuvant chemotherapy).
Experimental group: subjects randomly assigned to the experimental group were required to start treatment within 7 working days. The experimental group received hypofractionated radiotherapy with a total dose of 52.5Gy, 3.5 Gy/ fraction, 15 fractions, 5 fractions per week, and temozolomide was given for 21 days. Sequential temozolomide chemotherapy was started 4 weeks after the end of chemoradiotherapy. Sequential chemotherapy was given 5 days before each 28-day cycle. During the study period, the experimental group was required to complete the vital signs, physical examination, laboratory examination and other examinations within the specified period. After randomization, the experimental group underwent radiologic response assessments (or as deemed necessary by the investigator based on clinical symptoms) and QOLs at the end of radiotherapy, 3-4 weeks after the end of radiotherapy, and every 12 weeks (±7 days). Radiologic response assessments required plain and contrast-enhanced magnetic resonance imaging. If there were residual lesions after surgery, measurable lesions were evaluated according to RANO standard case criteria.
Control group: subjects randomly assigned to the experimental group were treated within 7 working days. The control group received conventional fractionated radiotherapy with a dose of 60Gy, 2Gy per fraction, 30 fractions, 5 fractions per week, and temozolomide was given for a total of 42 days. Sequential temozolomide chemotherapy was started 4 weeks after the end of chemoradiotherapy. Sequential chemotherapy was given 5 days before each 28-day cycle. During the study period, the experimental group was required to complete the vital signs, physical examination, laboratory examination and other examinations within the specified period. After randomization, the experimental group underwent radiologic response assessments (or as deemed necessary by the investigator based on clinical symptoms) and QOLs at the end of radiotherapy, 3-4 weeks after the end of radiotherapy, and every 12 weeks (±7 days). Radiologic response assessments required plain and contrast-enhanced magnetic resonance imaging. Measurable lesions assessed according to RANO criteria were required if residual lesions were present after surgery.
- Conditions
- Glioblastoma
- Being tested
- hypofractionated postoperative radiotherapy, Conventionally fractionated postoperative radiotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionated postoperative radiotherapyRadiation
hypofractionated radiotherapy with a total dose of 52.5Gy, 3.5 Gy/ fraction, 15 fractions, 5 fractions per week,
Conventionally fractionated postoperative radiotherapyRadiation
Conventionally fractionated radiotherapy with a total dose of 60 Gy, 2 Gy/ fraction, 30 fractions, 5 fractions per week,
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | subjects randomly assigned to the experimental group were required to start treatment within 7 working days. The experimental group received hypofractionated radiotherapy with a total dose of 52.5Gy, 3.5 Gy/ fraction, 15 fractions, 5 fractions per week, and temozolomide was given for 21 days. Sequential temozolomide chemotherapy was started 4 weeks after the end of chemoradiotherapy. Sequential chemotherapy was given 5 days before each 28-day cycle. Receives: Radiation: hypofractionated postoperative radiotherapy |
| Control group | Other | subjects randomly assigned to the experimental group were treated within 7 working days. The control group received conventional fractionated radiotherapy with a dose of 60Gy, 2Gy per fraction, 30 fractions, 5 fractions per week, and temozolomide was given for a total of 42 days. Sequential temozolomide chemotherapy was started 4 weeks after the end of chemoradiotherapy. Sequential chemotherapy was given 5 days before each 28-day cycle. Receives: Radiation: Conventionally fractionated postoperative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
It was defined as the time between the start of the randomization date and the death of the subject due to various causes.
Measured: 18 months
Secondary outcomes (2)
Progression-free survival
The experimental and control groups were defined as the time from randomization to tumor progression (according to RANO criteria) or death from any cause, whichever occurred first.
Measured: 12 months
Time to disease progression
Interval between the date of randomization and the occurrence of radiographic progression according to RANO criteria.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start13 Aug 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740955
- Sponsor's protocol ID
- HR-3
- Status last verified
- Aug 2024
- First submitted
- 15 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Panet-Raymond V, Souhami L, Roberge D, Kavan P, Shakibnia L, Muanza T, Lambert C, Leblanc R, Del Maestro R, Guiot MC, Shenouda G. Accelerated hypofractionated intensity-modulated radiotherapy with concurrent and adjuvant temozolomide for patients with glioblastoma multiforme: a safety and efficacy analysis. Int J Radiat Oncol Biol Phys. 2009 Feb 1;73(2):473-8. doi: 10.1016/j.ijrobp.2008.04.030. Epub 2008 Jun 12.
PubMed 18554821Sultanem K, Patrocinio H, Lambert C, Corns R, Leblanc R, Parker W, Shenouda G, Souhami L. The use of hypofractionated intensity-modulated irradiation in the treatment of glioblastoma multiforme: preliminary results of a prospective trial. Int J Radiat Oncol Biol Phys. 2004 Jan 1;58(1):247-52. doi: 10.1016/s0360-3016(03)00819-8.
PubMed 14697445Hingorani M, Colley WP, Dixit S, Beavis AM. Hypofractionated radiotherapy for glioblastoma: strategy for poor-risk patients or hope for the future? Br J Radiol. 2012 Sep;85(1017):e770-81. doi: 10.1259/bjr/83827377.
PubMed 22919020Laperriere N, Zuraw L, Cairncross G; Cancer Care Ontario Practice Guidelines Initiative Neuro-Oncology Disease Site Group. Radiotherapy for newly diagnosed malignant glioma in adults: a systematic review. Radiother Oncol. 2002 Sep;64(3):259-73. doi: 10.1016/s0167-8140(02)00078-6.
PubMed 12242114Roa W, Kepka L, Kumar N, Sinaika V, Matiello J, Lomidze D, Hentati D, Guedes de Castro D, Dyttus-Cebulok K, Drodge S, Ghosh S, Jeremic B, Rosenblatt E, Fidarova E. International Atomic Energy Agency Randomized Phase III Study of Radiation Therapy in Elderly and/or Frail Patients With Newly Diagnosed Glioblastoma Multiforme. J Clin Oncol. 2015 Dec 10;33(35):4145-50. doi: 10.1200/JCO.2015.62.6606. Epub 2015 Sep 21.
PubMed 26392096Roa W, Brasher PM, Bauman G, Anthes M, Bruera E, Chan A, Fisher B, Fulton D, Gulavita S, Hao C, Husain S, Murtha A, Petruk K, Stewart D, Tai P, Urtasun R, Cairncross JG, Forsyth P. Abbreviated course of radiation therapy in older patients with glioblastoma multiforme: a prospective randomized clinical trial. J Clin Oncol. 2004 May 1;22(9):1583-8. doi: 10.1200/JCO.2004.06.082. Epub 2004 Mar 29.
PubMed 15051755Malmstrom A, Gronberg BH, Marosi C, Stupp R, Frappaz D, Schultz H, Abacioglu U, Tavelin B, Lhermitte B, Hegi ME, Rosell J, Henriksson R; Nordic Clinical Brain Tumour Study Group (NCBTSG). Temozolomide versus standard 6-week radiotherapy versus hypofractionated radiotherapy in patients older than 60 years with glioblastoma: the Nordic randomised, phase 3 trial. Lancet Oncol. 2012 Sep;13(9):916-26. doi: 10.1016/S1470-2045(12)70265-6. Epub 2012 Aug 8.
PubMed 22877848Keime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, Guillamo JS, Jadaud E, Colin P, Bondiau PY, Menei P, Loiseau H, Bernier V, Honnorat J, Barrie M, Mokhtari K, Mazeron JJ, Bissery A, Delattre JY; Association of French-Speaking Neuro-Oncologists. Radiotherapy for glioblastoma in the elderly. N Engl J Med. 2007 Apr 12;356(15):1527-35. doi: 10.1056/NEJMoa065901.
PubMed 17429084Athanassiou H, Synodinou M, Maragoudakis E, Paraskevaidis M, Verigos C, Misailidou D, Antonadou D, Saris G, Beroukas K, Karageorgis P. Randomized phase II study of temozolomide and radiotherapy compared with radiotherapy alone in newly diagnosed glioblastoma multiforme. J Clin Oncol. 2005 Apr 1;23(10):2372-7. doi: 10.1200/JCO.2005.00.331.
PubMed 15800329Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.
PubMed 19269895Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
PubMed 15758009Cabrera AR, Kirkpatrick JP, Fiveash JB, Shih HA, Koay EJ, Lutz S, Petit J, Chao ST, Brown PD, Vogelbaum M, Reardon DA, Chakravarti A, Wen PY, Chang E. Radiation therapy for glioblastoma: Executive summary of an American Society for Radiation Oncology Evidence-Based Clinical Practice Guideline. Pract Radiat Oncol. 2016 Jul-Aug;6(4):217-225. doi: 10.1016/j.prro.2016.03.007. Epub 2016 Mar 31.
PubMed 27211230Central Brain Tumor Registry of the United States (CBTRUS) CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2004-2008. Hinsdale, IL: Central Brain Tumor Registry of the United States; 2012. Feb, pp. 1-58.
Wrensch M, Minn Y, Chew T, Bondy M, Berger MS. Epidemiology of primary brain tumors: current concepts and review of the literature. Neuro Oncol. 2002 Oct;4(4):278-99. doi: 10.1093/neuonc/4.4.278.
PubMed 12356358
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Controlled, Multi-center Clinical Trial of Hypofractionated Postoperative Radiotherapy for Adult Glioblastoma
- ClinicalTrials.gov ID
- NCT06740955
- Acronym / sponsor ID
- HR-3
- Conditions
- Glioblastoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a multicenter, open-label, randomized, controlled, phase Ⅲ clinical trial to evaluate the efficacy and safety of hypofractionated concurrent radiotherapy followed by sequential temozolomide after surgery in patients with newly diagnosed glioblastoma.
A total of 420 subjects were enrolled in this study, randomized 1:1. According to the changes in overall survival time after postoperative concurrent chemoradiotherapy with different radiation doses, the stratification factors included the extent of surgical resection (total resection vs subtotal resection); The time of postoperative concurrent chemoradiotherapy (less than 28 days or more than 28 days); MGMT promoter methylation expression (positive or negative).
The study design was as follows: Participants were required to undergo a screening period within 14 days before randomization to determine eligibility. Subjects who met the inclusion criteria were randomly divided into two groups at a 1:1 ratio: trial group, hypofractionated concurrent chemoradiotherapy followed by at least 6 cycles of adjuvant temozolomide; The control group was treated with the existing standardized treatment (standard dose of concurrent chemoradiotherapy and at least 6 cycles of temozolomide adjuvant chemotherapy).
Experimental group: subjects randomly assigned to the experimental group were required to start treatment within 7 working days. The experimental group received hypofractionated radiotherapy with a total dose of 52.5Gy, 3.5 Gy/ fraction, 15 fractions, 5 fractions per week, and temozolomide was given for 21 days. Sequential temozolomide chemotherapy was started 4 weeks after the end of chemoradiotherapy. Sequential chemotherapy was given 5 days before each 28-day cycle. During the study period, the experimental group was required to complete the vital signs, physical examination, laboratory examination and other examinations within the specified period. After randomization, the experimental group underwent radiologic response assessments (or as deemed necessary by the investigator based on clinical symptoms) and QOLs at the end of radiotherapy, 3-4 weeks after the end of radiotherapy, and every 12 weeks (±7 days). Radiologic response assessments required plain and contrast-enhanced magnetic resonance imaging. If there were residual lesions after surgery, measurable lesions were evaluated according to RANO standard case criteria.
Control group: subjects randomly assigned to the experimental group were treated within 7 working days. The control group received conventional fractionated radiotherapy with a dose of 60Gy, 2Gy per fraction, 30 fractions, 5 fractions per week, and temozolomide was given for a total of 42 days. Sequential temozolomide chemotherapy was started 4 weeks after the end of chemoradiotherapy. Sequential chemotherapy was given 5 days before each 28-day cycle. During the study period, the experimental group was required to complete the vital signs, physical examination, laboratory examination and other examinations within the specified period. After randomization, the experimental group underwent radiologic response assessments (or as deemed necessary by the investigator based on clinical symptoms) and QOLs at the end of radiotherapy, 3-4 weeks after the end of radiotherapy, and every 12 weeks (±7 days). Radiologic response assessments required plain and contrast-enhanced magnetic resonance imaging. Measurable lesions assessed according to RANO criteria were required if residual lesions were present after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Radiation: hypofractionated postoperative radiotherapysubjects randomly assigned to the experimental group were required to start treatment within 7 working days. The experimental group received hypofractionated radiotherapy with a total dose of 52.5Gy, 3.5 Gy/ fraction, 15 fractions, 5 fractions per week, and temozolomide was given for 21 days. Sequential temozolomide chemotherapy was started 4 weeks after the end of chemoradiotherapy. Sequential chemotherapy was given 5 days before each 28-day cycle. |
| Control group | Other | Radiation: Conventionally fractionated postoperative radiotherapysubjects randomly assigned to the experimental group were treated within 7 working days. The control group received conventional fractionated radiotherapy with a dose of 60Gy, 2Gy per fraction, 30 fractions, 5 fractions per week, and temozolomide was given for a total of 42 days. Sequential temozolomide chemotherapy was started 4 weeks after the end of chemoradiotherapy. Sequential chemotherapy was given 5 days before each 28-day cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed glioblastoma confirmed by histopathology or molecular pathology;
- Complete or partial tumor resection or biopsy via neurosurgery;
- The age of signing the informed consent form was 18-70 years old, male or female; (4) KPS score ≥60; (5) expected survival time ≥6 months;
- 6. Radiotherapy should be started within 6 weeks after surgery; 7. Vital organ function meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days) : Normal bone marrow reserve: white blood cell (WBC) ≥3.0×109/L, neutrophil count (NEUT) ≥1.5×109/L, platelet count (PLT) ≥80×109/L, hemoglobin (Hb) ≥90 g/L Normal renal function or serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥50 ml/ minute (Cockcroft-Gault equation) Normal liver function or total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 times the upper limit of normal (ULN); 8. Able and willing to follow the study and follow-up procedures; 9. Men and women of childbearing potential must agree to use adequate contraception throughout the study and for 6 months after the end of treatment. Female subjects of childbearing potential were required to have a negative blood pregnancy test within 72 hours before the first dose.
- 10. The subjects voluntarily participated in this clinical study and signed the informed consent form. The compliance was good and the subjects could cooperate with the follow-up.
Key exclusion criteria (17 listed)
- Received any previous systemic antitumor therapy against the target lesion;
- Prior radiation therapy to the head;
- Had a history of low-grade glioma and the current tumor transitioned to glioblastoma;
- The patient had glioma in other parts in the past, and now had metastasis, and the metastatic site was glioblastoma.
- Subjects were unable to undergo MRI examination or unable to undergo enhanced MRI examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypofractionated postoperative radiotherapyhypofractionated radiotherapy with a total dose of 52.5Gy, 3.5 Gy/ fraction, 15 fractions, 5 fractions per week, | Radiation | Experimental group |
| Conventionally fractionated postoperative radiotherapyConventionally fractionated radiotherapy with a total dose of 60 Gy, 2 Gy/ fraction, 30 fractions, 5 fractions per week, | Radiation | Control group |
Primary outcome
Overall Survival
Time frame: 18 months
It was defined as the time between the start of the randomization date and the death of the subject due to various causes.
2 secondary outcomes
Progression-free survival
Time frame: 12 months
Time to disease progression
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Background: PubMed 18554821Panet-Raymond V, Souhami L, Roberge D, Kavan P, Shakibnia L, Muanza T, Lambert C, Leblanc R, Del Maestro R, Guiot MC, Shenouda G. Accelerated hypofractionated intensity-modulated radiotherapy with concurrent and adjuvant temozolomide for patients with glioblastoma multiforme: a safety and efficacy analysis. Int J Radiat Oncol Biol Phys. 2009 Feb 1;73(2):473-8. doi: 10.1016/j.ijrobp.2008.04.030. Epub 2008 Jun 12.
- Background: PubMed 14697445Sultanem K, Patrocinio H, Lambert C, Corns R, Leblanc R, Parker W, Shenouda G, Souhami L. The use of hypofractionated intensity-modulated irradiation in the treatment of glioblastoma multiforme: preliminary results of a prospective trial. Int J Radiat Oncol Biol Phys. 2004 Jan 1;58(1):247-52. doi: 10.1016/s0360-3016(03)00819-8.
- Background: PubMed 22919020Hingorani M, Colley WP, Dixit S, Beavis AM. Hypofractionated radiotherapy for glioblastoma: strategy for poor-risk patients or hope for the future? Br J Radiol. 2012 Sep;85(1017):e770-81. doi: 10.1259/bjr/83827377.
- Background: PubMed 12242114Laperriere N, Zuraw L, Cairncross G; Cancer Care Ontario Practice Guidelines Initiative Neuro-Oncology Disease Site Group. Radiotherapy for newly diagnosed malignant glioma in adults: a systematic review. Radiother Oncol. 2002 Sep;64(3):259-73. doi: 10.1016/s0167-8140(02)00078-6.
- Background: PubMed 26392096Roa W, Kepka L, Kumar N, Sinaika V, Matiello J, Lomidze D, Hentati D, Guedes de Castro D, Dyttus-Cebulok K, Drodge S, Ghosh S, Jeremic B, Rosenblatt E, Fidarova E. International Atomic Energy Agency Randomized Phase III Study of Radiation Therapy in Elderly and/or Frail Patients With Newly Diagnosed Glioblastoma Multiforme. J Clin Oncol. 2015 Dec 10;33(35):4145-50. doi: 10.1200/JCO.2015.62.6606. Epub 2015 Sep 21.
- Background: PubMed 15051755Roa W, Brasher PM, Bauman G, Anthes M, Bruera E, Chan A, Fisher B, Fulton D, Gulavita S, Hao C, Husain S, Murtha A, Petruk K, Stewart D, Tai P, Urtasun R, Cairncross JG, Forsyth P. Abbreviated course of radiation therapy in older patients with glioblastoma multiforme: a prospective randomized clinical trial. J Clin Oncol. 2004 May 1;22(9):1583-8. doi: 10.1200/JCO.2004.06.082. Epub 2004 Mar 29.
- Background: PubMed 22877848Malmstrom A, Gronberg BH, Marosi C, Stupp R, Frappaz D, Schultz H, Abacioglu U, Tavelin B, Lhermitte B, Hegi ME, Rosell J, Henriksson R; Nordic Clinical Brain Tumour Study Group (NCBTSG). Temozolomide versus standard 6-week radiotherapy versus hypofractionated radiotherapy in patients older than 60 years with glioblastoma: the Nordic randomised, phase 3 trial. Lancet Oncol. 2012 Sep;13(9):916-26. doi: 10.1016/S1470-2045(12)70265-6. Epub 2012 Aug 8.
- Background: PubMed 17429084Keime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, Guillamo JS, Jadaud E, Colin P, Bondiau PY, Menei P, Loiseau H, Bernier V, Honnorat J, Barrie M, Mokhtari K, Mazeron JJ, Bissery A, Delattre JY; Association of French-Speaking Neuro-Oncologists. Radiotherapy for glioblastoma in the elderly. N Engl J Med. 2007 Apr 12;356(15):1527-35. doi: 10.1056/NEJMoa065901.
- Background: PubMed 15800329Athanassiou H, Synodinou M, Maragoudakis E, Paraskevaidis M, Verigos C, Misailidou D, Antonadou D, Saris G, Beroukas K, Karageorgis P. Randomized phase II study of temozolomide and radiotherapy compared with radiotherapy alone in newly diagnosed glioblastoma multiforme. J Clin Oncol. 2005 Apr 1;23(10):2372-7. doi: 10.1200/JCO.2005.00.331.
- Background: PubMed 19269895Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.
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- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypofractionated postoperative radiotherapy and Conventionally fractionated postoperative radiotherapy in people with Glioblastoma, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact 硙岩 石 (13944152797, drwyshi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06740955, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.