gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas (POLCA)
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ClinicalTrials.gov Identifier: NCT02444000 |
Recruitment Status :
Recruiting
First Posted : May 14, 2015
Last Update Posted : January 25, 2017
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Condition or disease | Intervention/treatment | Phase |
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Anaplastic Gliomas With 1p/19q Codeletion | Drug: PCV chemotherapy alone Drug: Radiotherapy+PCV chemotherapy | Phase 3 |
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 31 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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 280 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Trial of Delayed Radiotherapy in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Oligodendroglial Tumors: the POLCA Trial. |
Study Start Date : | June 2015 |
Estimated Primary Completion Date : | June 2024 |
Estimated Study Completion Date : | June 2024 |

Arm | Intervention/treatment |
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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
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Drug: PCV chemotherapy alone
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 |
Active Comparator: control
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
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Drug: Radiotherapy+PCV chemotherapy
Radiotherapy followed by 6 cycles of PCV |
- 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.
- progression free survival [ Time Frame: 9 years ]
- overall survival [ Time Frame: 9 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria :
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
- 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
Exclusion criteria :
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444000
Contact: Jean-Yves Delattre, MD, PhD | +33(0) 1 42 16 03 85 |
France | |
Groupe Hospitalier Pitié Salpetriere | Recruiting |
Paris, France, 75013 | |
Contact: Jean-Yves Delattre, MD, PhD +33(0) 1 42 16 03 85 jean-yves.delattre@aphp.fr |
Principal Investigator: | Jean-Yves Delattre, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT02444000 |
Other Study ID Numbers: |
P130097 |
First Posted: | May 14, 2015 Key Record Dates |
Last Update Posted: | January 25, 2017 |
Last Verified: | August 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
chemotherapy PCV radiotherapy post operative treatment |
anaplastic gliomas 1p/19q codeletion cognition |
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |