Primary Chemotherapy by BCNU-TMZ Combination in Newly Diagnosed Anaplastic Oligodendrocytic Tumor… (NCT04755023) | Clinical Trial Compass
CompletedPhase 2
Primary Chemotherapy by BCNU-TMZ Combination in Newly Diagnosed Anaplastic Oligodendrocytic Tumors: Phase II Trial With Translational Molecular Analysis
France53 participantsStarted 2005-12-21
Plain-language summary
The first-line treatment of anaplastic oligodendrogliomas, radiotherapy exclusive or combined with PCV, will be defined by the pending results of phase III of the EORTC.
If the phase II study proposed here achieves its objective, it may help define a new treatment regimen that will be compared to the standard arm from phase III of the EORTC.
In addition, this study, by prospectively testing the predictive value of 1p and 19q deletions and of REGF amplification, may allow characterization of patients using these markers. If validated, this characterization can constitute a key element in any therapeutic evaluation (patient stratification), and potentially a major tool for medical decision support in these tumors.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically proven oligodendroglioma or anaplastic oligoastrocytoma, newly diagnosed, resulting or not from a low grade glioma
* Tumor with measurable contrast enhancement (at least 15 mm in diameter)
* Surgical procedure limited to a biopsy or partial excision
* In the event of partial excision, an early postoperative check-up (\<72 hours) performed at best by MRI, if not by CT, is required.
* Time between surgery and inclusion less than or equal to one and a half months (45 days)
* Age\> 18 years old; \<70
* Karnofsky index\> 60
* Stable or reduced dose of corticosteroids in the 15 days prior to inclusion
* Polynuclear neutrophils\> 1500; platelets\> 100,000
* Bilirubin \<1.25 x UNL; SGOT, SGPT, PAL \<2.5 x UNL
* Absence of serious uncontrolled pathology
* Patient having received and understood the information and having signed the consent
Exclusion Criteria:
* Presence of GBM foci within the tumor
* Absence of evaluable residue after surgery
* Previous chemotherapy or radiotherapy
* Unsatisfactory expected monitoring conditions
* Pregnant or breastfeeding woman; lack of effective contraception if of childbearing age
* History of malignant disease (with the exception of CIS of the cervix and basal cell cancer)
* Contraindications related to the examination of the I.R.M.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
Timeframe: At the end of Cycle 2 (each cycle is 28 days)
2
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
Timeframe: At the end of Cycle 4 (each cycle is 28 days)
3
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
Timeframe: At the end of Cycle 6 (each cycle is 28 days)
4
Objective response rate of the BCNU-TMZ combination administered before radiotherapy