A Phase 3 interventional study of Standard surgery and Intraoperative radiotherapy in Glioblastoma, sponsored by Universitätsmedizin Mannheim. Active, not recruiting at 19 sites in 8 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by Universitätsmedizin Mannheim · Phase 3, Interventional, and Treatment
INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to standard radiochemotherapy.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's enrollment of 314 is above the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Universitätsmedizin Mannheim is the lead sponsor of 78 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
Patients must have adequate organ functions
Bone marrow function:
Liver Function:
Renal Function:
Inclusion Criteria Related to Surgery:
Exclusion Criteria
Fertile patients refusing to use safe contraceptive methods during the study
Exclusion Criteria Related to Surgery:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard surgery plus intraoperative radiotherapy (20-30 Gy) followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
Procedure: Standard surgery · Radiation: Intraoperative radiotherapy · Radiation: Radiochemotherapy · Drug: Temozolomide
Standard surgery followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
Procedure: Standard surgery · Radiation: Radiochemotherapy · Drug: Temozolomide
Dose to applicator surface: 20-30 Gy; Carl Zeiss INTRABEAM System. IORT with a surface dose of 30 Gy is recommended.Should the proximity to any risk structure not allow to apply 30 Gy, a dose reduction by up to 10 Gy (resulting in a surface dose of 20 Gy) is allowed.
Also known as: IORT
EBRT to 60 Gy plus 75 mg/m2/d temozolomide
Adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
Median Progression-Free Survival
Determined according to modified Response Assessment in Neuro-Oncology (RANO) criteria and serial perfusion imaging
Time frame: 24 Months
Median Overall Survival
Time frame: 24 Months
PFS within a 1-2 cm margin around the cavity
Determined by serial contrast-enhanced MRI scans using modified RANO criteria and serial perfusion imaging
Time frame: 24 Months
OS with respect to Age
Median overall survival of patients \<65 vs. ≥ 65 years
Time frame: 24 Months
PFS with respect to Age
Progression-free survival of patients \<65 vs. ≥ 65 years; determined according to modified RANO criteria and serial perfusion imaging
Time frame: 24 Months
OS with respect to KPS
Median overall survival of patients with KPS 80-100% vs. 60-70%
Time frame: 24 Months
PFS with respect to KPS
Progression-free survival of patients with KPS 80-100% vs. 60-70%; determined according to modified RANO criteria and serial perfusion imaging
Time frame: 24 Months
OS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumor margin
Thickness of anticipated T1-Gd-enhancing (remaining) tumor margin as per the discretion of the surgeon (margin ≥0.5 cm or multiple spots of residual tumor within the cavity vs. \<0.5 cm)
Time frame: 24 Months
PFS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumor margin
Thickness of anticipated T1-Gd-enhancing (remaining) tumor margin as per the discretion of the surgeon (margin ≥0.5 cm or multiple spots of residual tumor within the cavity vs. \<0.5 cm); determined according to modified RANO criteria and serial perfusion imaging
Time frame: 24 Months
OS with respect to extent of resection
Early postoperative MRI scans must be used to determine the extent of resection (EoR). The EoR is given as sum of all maximum diameters of residual lesions in cm. OS will be calculated for the following groups: * Max Diameter group 0: 0 cm (no residual tumor) * Max Diameter group 1: \>0 to ≤1.5 cm (cumulative if multiple residual lesions) * Max Diameter group 2: \>1.5 cm (cumulative if multiple residual lesions)
Time frame: 24 Months
PFS with respect to extent of resection
Early postoperative MRI scans must be used to determine the extent of resection (EoR). The EoR is given as sum of all maximum diameters of residual lesions in cm. PFS will be determined according to modified RANO criteria and serial perfusion imaging for the following groups: * Max Diameter group 0: 0 cm (no residual tumor) * Max Diameter group 1: \>0 to ≤1.5 cm (cumulative if multiple residual lesions) * Max Diameter group 2: \>1.5 cm (cumulative if multiple residual lesions)
Time frame: 24 Months
OS with respect to MGMT promoter methylation status
OS in patients with promoter methylation vs. no promoter methylation
Time frame: 24 Months
PFS with respect to MGMT promoter methylation status
PFS in patients with promoter methylation vs. no promoter methylation; determined according to modified RANO criteria and serial perfusion imaging
Time frame: 24 Months
Quality of Life (QoL) questionnaire
Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20)
Time frame: 24 Months
Activities of daily living (ADL), assessed using the Barthel Index (Mahoney & Barthel, 1965).
Change in functional outcomes as measured by BI from its baseline value.
Time frame: 24 Months
Radiation-related (acute / early delayed / late) neurotoxicity
Assessed by regular neurological examinations and serial MRI scans
Time frame: 24 Months
Plan to share: No
Started Dec 2016 (actual). Primary completion is estimated for Nov 2025, 107 months after the start.
Of 43 phase 3 interventional studies under Glioblastoma, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 87. This study's planned 107 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Universitätsmedizin Mannheim