Anaplastic Gliomas With 1p/19q CodeletionPhase 3POLCANCT02444000
gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas
A Phase 3 study testing PCV chemotherapy alone and Radiotherapy+PCV chemotherapy in people with Anaplastic Gliomas With 1p/19q Codeletion, run by Assistance Publique - Hôpitaux de Paris at 33 sites in France.
Trial summary
Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk of neurocognitive deterioration without impairing overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Gliomas With 1p/19q Codeletion
- What is being tested?
- PCV chemotherapy alone and Radiotherapy+PCV chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 33 sitesFrance
- Study dates
- 22 Sep 2015to 21 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Histological confirmation of anaplastic glioma by central pathological review
- Tumor is co-deleted for 1p and 19q
- Age ≥ 18 years of age
- Newly diagnosed and ≤3 months from surgical diagnosis
- Willing and able to complete neurocognitive examination and the QOL
- Karnofsky performance status ≥ 60
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- The following laboratory values obtained ≤ 21 days prior to registration:
- Absolute neutrophil count (ANC) ≥1500 /mm3
- Platelet count ≥100,000 / mm3
- Hemoglobin > 9.0 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- SGOT (AST) ≤ 3 x ULN
- Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
- Provide informed written consent
Who cannot join
- Pregnant and nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception during this study and for up to 6 months following the completion of PCV.
- Received any prior radiation therapy or chemotherapy for any CNS neoplasm.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
France33 sites
CHU d'Amiens- CHU nord
Amiens, 80000
CHU D'Anger
Angers, 49000
CHU annecy genevois
Annecy, 74000
CHU de Bordaux
Bordeaux, 33000
Hopital de la Cavale Blanche
Brest, 29000
CHU de Caen
Caen, 30000
Hopital Gabriel Montpied
Clermont-Ferrand, 63000
CH Louis Pasteur
Colmar, 68000
Hopital François Mitterand
Dijon, 21000
CHU Sud Réunion
La Réunion, 97000
Hopital Roger Salengro
Lille, 59000
Chu Dupuytren
Limoges, 87000
Centre Hospitalier de Bretagne Sud - Hôpital du Scorff
Lorient, 56000
GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP
Lyon, 69000
Hôpital Pierre Wertheimer
Lyon, 69000
CHU la Timone
Marseille, 13000
Hopital CLAIRVAL
Marseille, 13000
ICM, Institut régional du Cancer de Montpellier
Montpellier, 34000
Institut de Cancérologie de l'Ouest (ICO) - site CLCC René Gauducheau
Nantes, 44000
Hopital PASTEUR
Nice, 06000
HIA du Val de Grâce
Paris, 75005
Hopital Saint Louis
Paris, 75010
Groupe Hospitalier Pitié Salpetriere
Paris, 75013
Centre Hospitalier Perpignan
Perpignan, 49000
CHU de Poitiers
Poitiers, 86000
CLCC Eugène Marquis
Rennes, 44000
CHU de Rouen
Rouen, 76000
Hôpital Nord, CHU de Saint-Etienne
Saint-Etienne, 42000
Institut Pul STRAUSS
Strasbourg, 67000
Hôpital Foch
Suresnes, 92000
IUCT Oncopole - CLCC Institut Claudius Regaud
Toulouse, 31000
CHU Bretonneau
Tours, 37000
CLCC Institut Gustave Roussy
Villejuif, 94800
About this study
Official title: A Randomized Trial of Delayed Radiotherapy in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Oligodendroglial Tumors: the POLCA Trial.
Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk of neurocognitive deterioration without impairing overall survival.
Read the detailed description
Multicentric, Randomized phase III study (1:1), Population: newly diagnosed 1p/19-codeleted anaplastic gliomas, Primary objective: To determine whether treating newly diagnosed 1p/19q-codeleted anaplastic gliomas with PCV alone can increase overall survival without neurocognitive deterioration Control group: radiotherapy followed by 6 cycles of PCV chemotherapy. Experimental group: 6 cycles of PCV chemotherapy (radiotherapy being deferred at the time of progression).
Number of centres participating: the 33 centers of the POLA network Recruitment duration: 7 years, the accrual rate being 40 patients per year, and patients are followed-up until the end of the trial.
- Being tested
- PCV chemotherapy alone, Radiotherapy+PCV chemotherapy
- Keywords
- chemotherapy, PCV, radiotherapy, post operative treatment, anaplastic gliomas, 1p/19q codeletion, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV chemotherapy aloneDrug
PCV cycles are 6 weeks long
PCV chemotherapy is given as:
Day 1: CCNU 110 mg/m2 orally; Days 8 and 29: vincristine 1.4 mg/m2 IV; Days 8 to 21: procarbazine 60 mg/m2 orally
Radiotherapy+PCV chemotherapyDrug
Radiotherapy followed by 6 cycles of PCV
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Administration of 6 cycles of PCV chemotherapy PCV chemotherapy is given as: Day 1: CCNU 110 mg/m2 orally; Days 8 and 29: vincristine 1.4 mg/m2 IV; Days 8 to 21: procarbazine 60 mg/m2 orally Receives: Drug: PCV chemotherapy alone |
| control | Active comparator | radiotherapy followed by 6 cycles of PCV chemotherapy given as: Day 1: CCNU 110 mg/m2 orally; Days 8 and 29: vincristine 1.4 mg/m2 IV; Days 8 to 21: procarbazine 60 mg/m2 orally Receives: Drug: Radiotherapy+PCV chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without neurocognitive deterioration
Survival without neurocognitive deterioration (whatever the cause of deterioration, i.e toxicity or tumor progression) defined as the time from study registration to failure in any of the 6 cognitive domains that will be explored (i.e memory, working memory, language, visuo-spatial ability, cognitive executive functions, behavioral executive functions) or death due to any cause, whichever occurs first.
Measured: 9 years
Secondary outcomes (2)
progression free survival
Measured: 9 years
overall survival
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study start22 Sep 2015
- Primary completion11 Oct 2022
- Study completion21 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic Gliomas With 1p/19q CodeletionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Association de Neuro-Oncologues d'Expression Francaise
- Responsible party
- Sponsor
- Investigators
- Caroline DEHAIS, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444000
- Sponsor's protocol ID
- P130917
- Acronym
- POLCA
- Status last verified
- Jan 2026
- First submitted
- 12 May 2015
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Delayed Radiotherapy in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Oligodendroglial Tumors: the POLCA Trial.
- ClinicalTrials.gov ID
- NCT02444000
- Acronym / sponsor ID
- POLCA / P130917
- Keywords
- chemotherapy, PCV, radiotherapy, post operative treatment, anaplastic gliomas, 1p/19q codeletion, cognition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Association de Neuro-Oncologues d'Expression Francaise
- Study start
- 22 Sep 2015 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 21 Sep 2024 (actual)
- First posted
- 14 May 2015 (estimated)
- 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.
Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk of neurocognitive deterioration without impairing overall survival.
Detailed description
Multicentric, Randomized phase III study (1:1), Population: newly diagnosed 1p/19-codeleted anaplastic gliomas, Primary objective: To determine whether treating newly diagnosed 1p/19q-codeleted anaplastic gliomas with PCV alone can increase overall survival without neurocognitive deterioration Control group: radiotherapy followed by 6 cycles of PCV chemotherapy. Experimental group: 6 cycles of PCV chemotherapy (radiotherapy being deferred at the time of progression).
Number of centres participating: the 33 centers of the POLA network Recruitment duration: 7 years, the accrual rate being 40 patients per year, and patients are followed-up until the end of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Drug: PCV chemotherapy aloneAdministration of 6 cycles of PCV chemotherapy PCV chemotherapy is given as: Day 1: CCNU 110 mg/m2 orally; Days 8 and 29: vincristine 1.4 mg/m2 IV; Days 8 to 21: procarbazine 60 mg/m2 orally |
| control | Active comparator | Drug: Radiotherapy+PCV chemotherapyradiotherapy followed by 6 cycles of PCV chemotherapy given as: Day 1: CCNU 110 mg/m2 orally; Days 8 and 29: vincristine 1.4 mg/m2 IV; Days 8 to 21: procarbazine 60 mg/m2 orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histological confirmation of anaplastic glioma by central pathological review
- Tumor is co-deleted for 1p and 19q
- Age ≥ 18 years of age
- Newly diagnosed and ≤3 months from surgical diagnosis
- Willing and able to complete neurocognitive examination and the QOL
Key exclusion criteria (3 listed)
- Pregnant and nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception during this study and for up to 6 months following the completion of PCV.
- Received any prior radiation therapy or chemotherapy for any CNS neoplasm.
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 |
|---|---|---|
| PCV chemotherapy alonePCV cycles are 6 weeks long PCV chemotherapy is given as: Day 1: CCNU 110 mg/m2 orally; Days 8 and 29: vincristine 1.4 mg/m2 IV; Days 8 to 21: procarbazine 60 mg/m2 orally | Drug | experimental |
| Radiotherapy+PCV chemotherapyRadiotherapy followed by 6 cycles of PCV | Drug | control |
Primary outcome
Survival without neurocognitive deterioration
Time frame: 9 years
Survival without neurocognitive deterioration (whatever the cause of deterioration, i.e toxicity or tumor progression) defined as the time from study registration to failure in any of the 6 cognitive domains that will be explored (i.e memory, working memory, language, visuo-spatial ability, cognitive executive functions, behavioral executive functions) or death due to any cause, whichever occurs first.
2 secondary outcomes
progression free survival
Time frame: 9 years
overall survival
Time frame: 9 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Caroline DEHAIS, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PCV chemotherapy alone and Radiotherapy+PCV chemotherapy in people with Anaplastic Gliomas With 1p/19q Codeletion, run by Assistance Publique - Hôpitaux de Paris at 33 sites 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 14 inclusion and 3 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: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without neurocognitive deterioration (time frame: 9 years). 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 23 Jan 2026.