Clinical trial NCT00863460: Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients
Official title: Prospective , Multicentric, Randomized Phase II Study, Evaluating the Role of Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue After Conventional Chemotherapy for Primary Central Nervous System in Young Patients (< 60 y)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Primary Central Nervous System Lymphoma
Lead sponsor: Institut Curie
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Hoffmann-La Roche
name: Amgen
name: Pierre Fabre Laboratories
First posted: 2009-03-18
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose of the study :

To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.


Eligibility criteria: Inclusion Criteria:

* Histopathologically or cytologically proven diagnostic of Primary CNS lymphoma
* All histological types of non-Hodgkin's lymphoma, except MALT
* Age \> 18 and \< 60 ans.
* Negative for HIV, HCV and HBV
* Written informed consent -

Exclusion Criteria:

* Age \< 18 or \> 60 ans
* Isolated intra-ocular lymphoma
* Previous history of indolent lymphoma
* Previous chemotherapy or radiotherapy for PCNSL
* Isolated CNS relapse of systemic NHL
* Previous history of cancer in the last 5 years, except basocellular carcinoma and non invasive cervix cancer
* Renal insufficiency or creatinin clearance \< 60 ml/min
* Liver enzymes \> 3N.
* Platelets \< 100 000/mm3 or neutrophils \< 1500/mm3)
* Previous history of organ transplantation or other cause of severe immunodeficiency
* Pregnancy or active sexual women with no contraception
* Unable to follow the protocol for any reason

Primary outcomes:
measure: 2-years progression-free survival in each arm
timeFrame: 2 years after inclusion
Secondary outcomes:
measure: Overall response rate at the end of the procedure
timeFrame: at the end of procedure at 1 and 2 years
measure: Overall survival
timeFrame: 2 years after inclusion
measure: Event-free survival
timeFrame: 2 years after inclusion
measure: Neurotoxicity
timeFrame: each years during ten years
Other outcomes:
Locations:
city: Amiens
country: France
facility: Cancérologie Hôpital Sud
city: Angers
country: France
facility: Chu D'Angers
city: Argenteuil
country: France
facility: CHR Argenteuil
city: Besançon
country: France
facility: CHU de Besancon
city: Bordeaux
country: France
facility: Institut Bergonié
city: Clermont-Ferrand
country: France
facility: CHU Hôtel Dieu
city: Grenoble
country: France
facility: CHU Michalon
city: Lens
country: France
facility: Centre Hospitalier Lens
city: Limoges
country: France
facility: CHU de Limoges
city: Marseille
country: France
facility: CHU de la Timone
city: Nantes
country: France
facility: Hôtel Dieu Nantes
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nîmes
country: France
facility: CHU de Nimes
city: Paris
country: France
facility: GH Pitié-Salpétrière
city: Perpignan
country: France
facility: CHG Saint Jean
city: Poitiers
country: France
facility: CHU Hôpital Bernard
city: Reims
country: France
facility: Chu Reims
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Saint Cloud
country: France
facility: Centre René Huguenin
city: Saint-Priest en Jarez
country: France
facility: Institut de Cancérologie
city: Saint-Quentin
country: France
facility: CH de Saint-Quentin
city: Tours
country: France
facility: Hôpital Bretonneau
city: Vandoeuvre les Nancy
country: France
facility: CHU Nancy - Hôpital Neurologique
Study officials:
affiliation: Institut Curie - Hôpital René Huguenin
name: Carole Soussain, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.