Whole Brain Irradiation in Primary Central Nervous System (CNS) Lymphoma (PCNSL)

NCT00153530 | Completed Phase 4

• 1 other identifier: G-PCNSL-SG1
• Study Type: interventional
• Target: 604
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to deliver primary systemic high-dose methotrexate (MTX) treatment to PCNSL patients and to define the role of whole brain irradiation (WBI) in primary therapy, i.e., to analyze whether patients who have undergone primary chemotherapy can postpone irradiation with its possible late sequelae until recurrence without incurring losses in progression-free and overall survival. This is studied here for the first time worldwide in a systematic, controlled and randomized manner. In this study, one arm with six cycles of high-dose MTX and subsequent irradiation (A1), which comes closest to a "standard arm of primary therapy", at least according to the majority assessment, is compared to irradiation at recurrence with regard to time to progression and overall survival (A2). In primary therapy failure, it will also be analyzed to what extent salvage therapy with AraC is equivalent to irradiation as the "standard arm" with regard to time to progression and overall survival (arm B1 and B2).

Conditions

Central Nervous System Lymphoma

Keywords

primary central nervous system lymphoma

Outcome Measures

Primary Outcomes (1)

• overall survival

  3 years

Secondary Outcomes (1)

• progression-free survival

  3 years

Study Arms (2)

1

ACTIVE COMPARATOR

1 chemotherapy with radiotherapy

Drug: methotrexate; Radiation: radiotherapy

2

EXPERIMENTAL

chemotherapy without radiotherapy

Drug: methotrexate

Interventions

methotrexate DRUG

1. chemotherapy with radiotherapy 2. chemotherapy without radiotherapy

1; 2

radiotherapy RADIATION

whole-brain irradiation

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \> 18 years
• Life expectancy of at least 2 months
• Adequate bone marrow reserve with a peripheral granulocyte count of \> 1,500/µl and thrombocyte count of \> 100,000/µl; bilirubin in the normal range; GOT of \< three times the upper normal limit and adequate renal function with a creatinine clearance of \> 50 ml/min and serum creatinine in the normal range.
• Written informed consent
• In women of child-bearing age, pregnancy is excluded, effective contraception is necessary, and women should not be breast feeding.

You may not qualify if:

• Manifestation of lymphoma outside of the CNS
• Severe diseases in other organs which would make performing intensive chemotherapy impossible; Karnofsky index \> 50% due to previous diseases other than PCNSL. Karnofsky \> 30 will be accepted only due to the PCNSL.
• Active infection
• HIV positivity
• Previous treatment of PCNSL other than with corticosteroids, antiepileptics or diuretics
• Previous radiotherapy of the brain
• Concomitant or previous malignant diseases in the last 5 years except for an adequately treated basal cell carcinoma or cervical carcinoma in situ
• Immunosuppression, concomitant immunosuppressive therapy, or organ transplantation
• Ongoing chemotherapy for another disease

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• University Hospital Tuebingen: collaborator

Study Sites (1)

Charite Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Related Publications (1)

• Thiel E, Korfel A, Martus P, Kanz L, Griesinger F, Rauch M, Roth A, Hertenstein B, von Toll T, Hundsberger T, Mergenthaler HG, Leithauser M, Birnbaum T, Fischer L, Jahnke K, Herrlinger U, Plasswilm L, Nagele T, Pietsch T, Bamberg M, Weller M. High-dose methotrexate with or without whole brain radiotherapy for primary CNS lymphoma (G-PCNSL-SG-1): a phase 3, randomised, non-inferiority trial. Lancet Oncol. 2010 Nov;11(11):1036-47. doi: 10.1016/S1470-2045(10)70229-1. Epub 2010 Oct 20.

  PMID: 20970380 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

Methotrexate; Radiotherapy

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Eckhard Thiel, MD

  Charite Campus Benjamin Franklin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: May 1, 2000
• Study Completion: May 1, 2009
• Last Updated: December 24, 2009

Record last verified: 2009-07

Locations

DE (1)