GlioblastomaPhase 3THREE-GLEESNCT06477939
Study of Adding or Not Liposomal Transcrocetin (L-TC) With Concomitant HypoFractionated Radiation ThErapy and TEmozolomide in Newly Diagnosed GLioblastoma (GBM) Patients
A Phase 3 study testing Administration of L-TC and Radiotherapy plus Temozolomide in people with Glioblastoma, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial summary
This is phase III randomized, multicenter study adding or not intra-venous Liposomal Trasncrocetin (L-TC) to hypofractionated radiotherapy and concomitant Temozolomide followed by adjuvant Temozolomide in patients with histologically confirmed diagnosis of glioblastoma (GBM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Administration of L-TC and Radiotherapy plus Temozolomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2025to 31 Dec 2032
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort 1 - Non-operable patients
- Patients aged at least 18 years old and ≤ 70 years old; male or female.
- AND available biopsy
- AND Karnofsky index ≥ 50% at Screening
- Cohort 2 - Elderly patients
- Patients aged > 70 years old; male or female
Show all 26Show fewer
- AND Balducci score I or II. For patients classified in Balducci II, only light Balducci II will be included, as defined by a Charlson score <4 and a score of autonomy IADL = 4. In the oncogeriatric evaluation, symptoms related to brain cancer disease have not to be considered for this criterion.
- Karnofsky score (KPS) of ≥ 70% at Screening
- Regardless resection
- MRI at maximum 48h00 after surgery if partial, subtotal or macroscopically complete or supra-total resection
- For both cohorts
- Histologically confirmed diagnosis of glioblastoma (GBM) (2016 OMS classification) (Louis et al., 2016).
- Contrast enhancing disease on MRI within 14 days prior to screening.
- Within 2 weeks of baseline visit, hematologic and renal functions as specified: Absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,000/mm3, Hgb ≥ 9.0g/dL, creatinine ≤ 1.7mg/dl, total bilirubin ≤ 1.5mg/dL, blood urea nitrogen (BUN) within 2 times the upper limit of normal, transaminases ≤ 4 times above the upper limits of the institutional norm.
- Sexually active patients must use an acceptable method of contraception while receiving doses of study medication.
- Females of childbearing potential must have a negative serum or urine pregnancy test at screening and have additional pregnancy tests during study.
- Patient who cannot undergo MRI
- Pregnant or lactating woman.
- Serious concurrent infection or medical illness that would jeopardize the ability of the patient to receive study treatment with reasonable safety.
- Patients with previous cancer (< 5 years) except basocellular skin tumors and in situ cervix tumor
- Patient has a known hypersensitivity to crocetins, L-TC or any of its excipients.
- Contraindication of temozolomide as described in the Summary of product characteristics.
- Patient who cannot understand French language.
- Patient without French National Health insurance
- Patient who cannot be reliable for follow-up
- Patient under law protection
Who cannot join
- For both cohorts
- Any previous radiotherapy (RT) of the brain whatever the interval between previous brain RT and diagnoses of GBM)
- Any previous treatment of the GBM (except surgery) such as chemotherapy (including Gliadel wafer or gliasite application), immunotherapy, therapy with a biologic agent, hormonal therapy or Carmustine implant for brain tumors or immunotherapy, including vaccination (whatever the interval between previous treatment and diagnoses of GBM). Glucocorticoid therapy is allowed.
- Previous digestive disease with mis-absorption such as Crohn disease or chronic colitis
- Ongoing diarrhea grade ≥ 2 in the NCI CTCAE V5.0 (whatever the cause)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Institut de cancérologie Strasbourg Europe
Strasbourg, 67033
Manon VOEGELIN, 368339523 ext. +33, promotion-rc@icans.eu
About this study
Official title: Phase III Randomized Study of Adding or Not Liposomal Transcrocetin (L-TC) With Concomitant HypoFractionated Radiation ThErapy and TEmozolomide in Newly Diagnosed GLioblastoma (GBM) Patients to Evaluate Efficacy and Safety
This is phase III randomized, multicenter study adding or not intra-venous Liposomal Trasncrocetin (L-TC) to hypofractionated radiotherapy and concomitant Temozolomide followed by adjuvant Temozolomide in patients with histologically confirmed diagnosis of glioblastoma (GBM).
Read the detailed description
During this trial the L-TC will be administered with the hypofractionated chemoradiation treatment to two cohorts:
- Cohort 1 - Non-operable population defined as patients with age less than 70-year-old and with biopsy alone, Karnofski index we propose to use the L-TC with the hypofractionated chemoradiation treatment to two cohorts:
- Cohort 2 - Elderly population defined as patients aged of more than 70-year-old and with Balducci score 1 or with low Balducci score 2 with Karnofski index ≥ 70% but whatever the quality of the surgery. For patients classified with a score of Balducci II, the geriatric assessment is essential. Although we are aware of the heterogeneity of patients in this group, we hope that the geriatric assessment will make it possible to reduce this heterogeneity by including only patients with a Charlson score <4 and a score of autonomy IADL = 4
The eligible population will be randomized this combination with the treatment reference according to Perry et al publication
- Conditions
- Glioblastoma
- Being tested
- Administration of L-TC, Radiotherapy plus Temozolomide
- Keywords
- Brain tumors, Hypoxia, Liposomal transcrocetin
- Medical subject headings
- Glioblastoma, Brain Neoplasms, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of L-TCDrug
Administration of L-TC (300 mg) as an IV perfusion, before each radiotion session
Radiotherapy : delivered at 40.5 Gy in 15 fractions of 2.7 Gy - One fraction a day 5 fractions per week
+ Temozolomide delivered at a dose of 75 mg per square meter per day, given 7 days per week from the first day of radiotherapy until the last day of radiotherapy, but for no longer than 25 days.
Radiotherapy plus TemozolomideOther
Radiotherapy : delivered at 40.5 Gy in 15 fractions of 2.7 Gy - One fraction a day 5 fractions per week
+ Temozolomide delivered at a dose of 75 mg per square meter per day, given 7 days per week from the first day of radiotherapy until the last day of radiotherapy, but for no longer than 25 days.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy plus Temozolomide | Active comparator | Not described Receives: Drug: Administration of L-TC |
| Administration of L-TC on top of Radiotherapy plus Temozolomide | Experimental | Not described Receives: Other: Radiotherapy plus Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall Survival (OS) is defined as the length of time from the date of tumor resection surgery or definitive biopsy to the date of death.
Measured: Up to 24 months
Secondary outcomes (6)
Progression-Free Survival (PFS)
RANO criteria will be used to evaluate response
Measured: Up to 24 months
Evaluation of hypoxia markers
Hypoxia imaging markers between two groups: comparison of volumetric metrics
Measured: Up to 24 months
Quality of life
European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Core Quality of Life Questionnaire (QLQ-C30)
Measured: Up to 24 months
Quality of life (GBM module)
EORTC 20-Item QOL-Brain Neoplasm (QLQ-BN20)
Measured: Up to 24 months
Quality of life (specific for elderly population)
Quality-of-Life Questionnaire EORTC Elderly Cancer Patients (EORTC QLQ-ELD14)
Measured: Up to 24 months
Tolerance
EORTC Elderly Cancer Patients (EORTC QLQ-ELD14)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 554 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Collaborators
- LEAF4Life, Inc.
- Responsible party
- Sponsor
- Investigators
- Georges NOEL, MD, PhD, Principal investigator, Institut de cancérologie Strasbourg Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477939
- Sponsor's protocol ID
- 2020-008
- Other IDs
- 2024-515666-13-00
- Acronym
- THREE-GLEES
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of Adding or Not Liposomal Transcrocetin (L-TC) With Concomitant HypoFractionated Radiation ThErapy and TEmozolomide in Newly Diagnosed GLioblastoma (GBM) Patients to Evaluate Efficacy and Safety
- ClinicalTrials.gov ID
- NCT06477939
- Acronym / sponsor ID
- THREE-GLEES / 2020-008
- Conditions
- Glioblastoma
- Keywords
- Brain tumors, Hypoxia, Liposomal transcrocetin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 554 participants (estimated)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Collaborators
- LEAF4Life, Inc.
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 27 Jun 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 is phase III randomized, multicenter study adding or not intra-venous Liposomal Trasncrocetin (L-TC) to hypofractionated radiotherapy and concomitant Temozolomide followed by adjuvant Temozolomide in patients with histologically confirmed diagnosis of glioblastoma (GBM).
Detailed description
During this trial the L-TC will be administered with the hypofractionated chemoradiation treatment to two cohorts:
- Cohort 1 - Non-operable population defined as patients with age less than 70-year-old and with biopsy alone, Karnofski index we propose to use the L-TC with the hypofractionated chemoradiation treatment to two cohorts:
- Cohort 2 - Elderly population defined as patients aged of more than 70-year-old and with Balducci score 1 or with low Balducci score 2 with Karnofski index ≥ 70% but whatever the quality of the surgery. For patients classified with a score of Balducci II, the geriatric assessment is essential. Although we are aware of the heterogeneity of patients in this group, we hope that the geriatric assessment will make it possible to reduce this heterogeneity by including only patients with a Charlson score <4 and a score of autonomy IADL = 4
The eligible population will be randomized this combination with the treatment reference according to Perry et al publication
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy plus Temozolomide | Active comparator | Drug: Administration of L-TC |
| Administration of L-TC on top of Radiotherapy plus Temozolomide | Experimental | Other: Radiotherapy plus Temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Cohort 1 - Non-operable patients
- Cohort 2 - Elderly patients
- For both cohorts
- Patient who cannot undergo MRI
- Pregnant or lactating woman.
Key exclusion criteria (5 listed)
- For both cohorts
- Any previous radiotherapy (RT) of the brain whatever the interval between previous brain RT and diagnoses of GBM)
- Any previous treatment of the GBM (except surgery) such as chemotherapy (including Gliadel wafer or gliasite application), immunotherapy, therapy with a biologic agent, hormonal therapy or Carmustine implant for brain tumors or immunotherapy, including vaccination (whatever the interval between previous treatment and diagnoses of GBM). Glucocorticoid therapy is allowed.
- Previous digestive disease with mis-absorption such as Crohn disease or chronic colitis
- Ongoing diarrhea grade ≥ 2 in the NCI CTCAE V5.0 (whatever the cause)
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 |
|---|---|---|
| Administration of L-TCAdministration of L-TC (300 mg) as an IV perfusion, before each radiotion session Radiotherapy : delivered at 40.5 Gy in 15 fractions of 2.7 Gy - One fraction a day 5 fractions per week + Temozolomide delivered at a dose of 75 mg per square meter per day, given 7 days per week from the first day of radiotherapy until the last day of radiotherapy, but for no longer than 25 days. | Drug | Radiotherapy plus Temozolomide |
| Radiotherapy plus TemozolomideRadiotherapy : delivered at 40.5 Gy in 15 fractions of 2.7 Gy - One fraction a day 5 fractions per week + Temozolomide delivered at a dose of 75 mg per square meter per day, given 7 days per week from the first day of radiotherapy until the last day of radiotherapy, but for no longer than 25 days. | Other | Administration of L-TC on top of Radiotherapy plus Temozolomide |
Primary outcome
Overall Survival
Time frame: Up to 24 months
Overall Survival (OS) is defined as the length of time from the date of tumor resection surgery or definitive biopsy to the date of death.
6 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Evaluation of hypoxia markers
Time frame: Up to 24 months
Quality of life
Time frame: Up to 24 months
Quality of life (GBM module)
Time frame: Up to 24 months
Quality of life (specific for elderly population)
Time frame: Up to 24 months
Tolerance
Time frame: Up to 24 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 27 Jun 2024.
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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.
Georges NOEL, MD, PhD principal investigator
Institut de cancérologie Strasbourg Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Administration of L-TC and Radiotherapy plus Temozolomide in people with Glioblastoma, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
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 26 inclusion and 5 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: opening soon, as of the sponsor's last update on 27 Jun 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Manon VOEGELIN (368767360 ext. +33, promotion-rc@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2024.