NCT00863460

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_2

Geographic Reach
1 country

23 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2016

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

7.6 years

First QC Date

March 16, 2009

Last Update Submit

February 4, 2019

Conditions

Primary Central Nervous System Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 2-years progression-free survival in each arm

    2 years after inclusion

Secondary Outcomes (4)

  • 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

    2 years after inclusion

  • Neurotoxicity

    each years during ten years

Study Arms (2)

A

ACTIVE COMPARATOR

MTX-based chemotherapy followed by WBRT

Radiation: cranial radiotherapyDrug: MTX based chemotherapy

B

EXPERIMENTAL

MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue

Drug: intensive chemotherapy and hematopoietic stem cell rescueDrug: MTX based chemotherapy

Interventions

cranial radiotherapyRADIATION

40 Gy

A
intensive chemotherapy and hematopoietic stem cell rescueDRUG

intensive chemotherapy and hematopoietic stem cell rescue

Also known as: Thiotepa IV (250 mg/m²/day) day-9 day-8 day-7, Busulfan IV (0.8 mg/kg X 10) day-6 to day-4, Cyclophosphamide IV (60 mg/kg/day) day-3 & day-2, Reinjection of hematopoietic stem cells day0
B
MTX based chemotherapyDRUG

R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58\&59 and days79\&80

Also known as: R-RMVP :, Rituximab IV if LNH type B (375 mg/m²) day1, Methotrexate IV (3g/m² during 30 minutes) day1 and day15, Etoposide IV (100 mg/m²) day2, Carmustine IV (100 mg/m²) day3, Prednisone PO (60 mg/m²/day)day1 to day5, R-Aracytine :, Aracytine IV (3g/m²) day1 & day2
AB

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Cancérologie Hôpital Sud

Amiens, 80054, France

Location

Chu D'Angers

Angers, France

Location

CHR Argenteuil

Argenteuil, 95100, France

Location

CHU de Besancon

Besançon, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

CHU Hôtel Dieu

Clermont-Ferrand, France

Location

CHU Michalon

Grenoble, 38043, France

Location

Centre Hospitalier Lens

Lens, France

Location

CHU de Limoges

Limoges, 87042, France

Location

CHU de la Timone

Marseille, 13009, France

Location

Hôtel Dieu Nantes

Nantes, France

Location

Centre Antoine Lacassagne

Nice, France

Location

CHU de Nimes

Nîmes, France

Location

GH Pitié-Salpétrière

Paris, 75013, France

Location

CHG Saint Jean

Perpignan, 66046, France

Location

CHU Hôpital Bernard

Poitiers, 86021, France

Location

Chu Reims

Reims, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Centre René Huguenin

Saint-Cloud, 92210, France

Location

Institut de Cancérologie

Saint-Priest-en-Jarez, France

Location

CH de Saint-Quentin

Saint-Quentin, France

Location

Hôpital Bretonneau

Tours, France

Location

CHU Nancy - Hôpital Neurologique

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (2)

  • 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.

    PMID: 35834762DERIVED

  • 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.

    PMID: 30785830DERIVED

MeSH Terms

Interventions

Prednisone

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Carole Soussain, MD

    Institut Curie - Hôpital René Huguenin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 18, 2009

Study Start

October 3, 2008

Primary Completion

May 17, 2016

Study Completion

May 1, 2026

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

FR(23)