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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT N° 2007-005378-30 |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Hoffmann-La Roche | INDUSTRY |
| Amgen | INDUSTRY |
| Pierre Fabre Laboratories |
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Purpose of the study :
To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | MTX-based chemotherapy followed by WBRT |
|
| B | Experimental | MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cranial radiotherapy | Radiation | 40 Gy |
| |
| intensive chemotherapy and hematopoietic stem cell rescue |
| Measure | Description | Time Frame |
|---|---|---|
| 2-years progression-free survival in each arm | 2 years after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate at the end of the procedure | at the end of procedure at 1 and 2 years | |
| Overall survival | 2 years after inclusion | |
| Event-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carole Soussain, MD | Institut Curie - Hôpital René Huguenin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancérologie Hôpital Sud | Amiens | 80054 | France | |||
| Chu D'Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35834762 | Derived | Houillier C, Dureau S, Taillandier L, Houot R, Chinot O, Molucon-Chabrot C, Schmitt A, Gressin R, Choquet S, Damaj G, Peyrade F, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Al Jijakli A, Morel P, Waultier A, Paillassa J, Chauchet A, Gastinne T, Laadhari M, Plissonnier AS, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients Age 60 Years and Younger: Long-Term Results of the Randomized Phase II PRECIS Study. J Clin Oncol. 2022 Nov 10;40(32):3692-3698. doi: 10.1200/JCO.22.00491. Epub 2022 Jul 14. | |
| 30785830 |
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| INDUSTRY |
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| Drug |
intensive chemotherapy and hematopoietic stem cell rescue |
|
|
| MTX based chemotherapy | Drug | R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58&59 and days79&80 |
|
|
| 2 years after inclusion |
| Neurotoxicity | each years during ten years |
| Angers |
| France |
| CHR Argenteuil | Argenteuil | 95100 | France |
| CHU de Besancon | Besançon | France |
| Institut Bergonié | Bordeaux | 33076 | France |
| CHU Hôtel Dieu | Clermont-Ferrand | France |
| CHU Michalon | Grenoble | 38043 | France |
| Centre Hospitalier Lens | Lens | France |
| CHU de Limoges | Limoges | 87042 | France |
| CHU de la Timone | Marseille | 13009 | France |
| Hôtel Dieu Nantes | Nantes | France |
| Centre Antoine Lacassagne | Nice | France |
| CHU de Nimes | Nîmes | France |
| GH Pitié-Salpétrière | Paris | 75013 | France |
| CHG Saint Jean | Perpignan | 66046 | France |
| CHU Hôpital Bernard | Poitiers | 86021 | France |
| Chu Reims | Reims | France |
| Hôpital Pontchaillou | Rennes | 35033 | France |
| Centre René Huguenin | Saint-Cloud | 92210 | France |
| Institut de Cancérologie | Saint-Priest-en-Jarez | France |
| CH de Saint-Quentin | Saint-Quentin | France |
| Hôpital Bretonneau | Tours | France |
| CHU Nancy - Hôpital Neurologique | Vandœuvre-lès-Nancy | 54500 | France |
| Derived |
| Houillier C, Taillandier L, Dureau S, Lamy T, Laadhari M, Chinot O, Molucon-Chabrot C, Soubeyran P, Gressin R, Choquet S, Damaj G, Thyss A, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Tanguy ML, Al Jijakli A, Morel P, Bourquard P, Moles MP, Chauchet A, Gastinne T, Constans JM, Langer A, Martin A, Moisson P, Lacomblez L, Martin-Duverneuil N, Delgadillo D, Turbiez I, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; Intergroupe GOELAMS-ANOCEF and the LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Results of the Intergroup ANOCEF-GOELAMS Randomized Phase II PRECIS Study. J Clin Oncol. 2019 Apr 1;37(10):823-833. doi: 10.1200/JCO.18.00306. Epub 2019 Feb 20. |
| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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